A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03375203
• Collaborator: (none)
• Enrollment: 365
• Locations: 56
• Arms: 5
• Actual Duration (Months): 16.3
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Disorders	Drug: Placebo; Drug: JNJ-42847922, 5 mg; Drug: JNJ-42847922, 10 mg; Drug: JNJ-42847922, 20 mg; Drug: Zolpidem	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 365 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder
• Actual Study Start Date: Nov 23, 2017
• Actual Primary Completion Date: Apr 3, 2019
• Actual Study Completion Date: Apr 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive matching placebo to JNJ-42847922 as oral capsules at normal study bedtime on Nights 1 through 14.	Drug: Placebo; Matching placebo will be administered once daily based upon dosing group.
Experimental: JNJ-42847922 5 milligram (mg) Participant will receive JNJ-42847922 5 mg dose as oral capsules at normal study bedtime on Nights 1 through 14.	Drug: JNJ-42847922, 5 mg; JNJ-42847922 will be administered as 5 mg (2*2.5 mg capsule) oral capsules once daily.; Other Names: MIN-202; Seltorexant
Experimental: JNJ-42847922 10 mg plus Placebo Participant will receive JNJ-42847922 10 mg as oral capsule and one placebo capsule at normal study bedtime on Nights 1 through 14.	Drug: Placebo; Matching placebo will be administered once daily based upon dosing group.; Drug: JNJ-42847922, 10 mg; JNJ-42847922 will be administered as 10 mg oral capsule once daily.; Other Names: MIN-202; Seltorexant
Experimental: JNJ-42847922 20 mg plus Placebo Participant will receive JNJ-42847922 20 mg as oral capsule and one placebo capsule at normal study bedtime on Nights 1 through 14.	Drug: Placebo; Matching placebo will be administered once daily based upon dosing group.; Drug: JNJ-42847922, 20 mg; JNJ-42847922 will be administered as 20 mg oral capsule once daily.; Other Names: MIN-202; Seltorexant
Experimental: Zolpidem plus Placebo Participants will receive Zolpidem 5 mg plus one placebo capsule or 10 mg dose as oral capsule at normal study bedtime on Nights 1 through 14.	Drug: Placebo; Matching placebo will be administered once daily based upon dosing group.; Drug: Zolpidem; Zolpidem will be administered as 5 mg or 10 mg (2*5mg capsule) oral capsule once daily based upon the local labeling information.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 [Baseline and Night 1]

   Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.

Secondary Outcome Measures

1. Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 [Baseline and over first 6 hours on Night 1]

   PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 1. Negative changes in WASO indicate improvement.

2. Change From Baseline in LPS as Measured by PSG on Night 13 [Baseline and Night 13]

   LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. Negative changes in LPS indicate improvement.

3. Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 [Baseline and over first 6 hours on Night 13]

   PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 13. Negative changes in WASO indicate improvement.

4. Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 [Baseline, Over 6 hours on Nights 1 and 13]

   TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.

5. Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 [Baseline, Over 8 hours on Nights 1 and 13]

   TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.

6. Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 [Baseline, Nights 1 and 13]

   Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percentage). Positive changes in SE indicate improvement.

7. Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 [Baseline, Days 1 and 13 (Hours 1 to 8)]

   Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement.

8. Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 [Baseline, Over 6 hours on Day 1 and 13]

   PSG was used to measure the number of night-time awakenings over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement.

9. Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 [Baseline, Day 1 and 13]

   PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement.

10. Change From Baseline in Wake After Final Awakening on Day 1 and 13 [Baseline, Day 1 and 13]

    PSG was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement.

11. Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 [Baseline, Day 1 and 13]

    PSG was used to measure number of night time awakenings per hour. Negative changes in nNAW/hr indicate improvement.

12. Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 [Baseline, Day 1 and 13]

    PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement.

13. Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 [Baseline, Day 1 and 13]

    PSG was used to measure REM duration (time to first REM period from sleep onset).

14. Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 [Baseline, Day 1 and 13]

    PSG was used to measure the REM latency. REM latency was defined as the time to first REM from sleep onset to reaching the first epoch of REM sleep.

15. Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 [Day 1 and 13]

    PSG was used to measure the sleep-onset REM in participants. REM sleep periods within 15 minutes from sleep onset were measured.

16. Change From Baseline in Number of Sleep Cycles on Day 1 and 13 [Baseline, Day 1 and 13]

    PSG was used to measure the number of sleep cycles.

17. Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 [Baseline, Day 1 and 13]

    PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Total time spent was sum of N1, N2 and N3. Positive changes in NREM duration indicate improvement.

18. Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) [Baseline, Days 2 and 14]

    CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement.

19. Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) [Baseline, Days 2 and 14]

    The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality (sQUAL) and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.

20. Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) [Baseline, Days 2 and 14]

    CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. CSD-M parameters analyzed include: s-nNAW. Negative change in s-nNAW indicate improvement.

21. Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 [Baseline, Days 8 and 14]

    PROMIS Sleep Disturbance (PROMIS-SD) Short Form subscale consists of a static 8-item questionnaire. Using a recall period of the past 7 days, it assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Each question has 5 response options ranging in value from 1 to 5. To find the total raw score for a short form with all questions answered, sum the values of the response to each question and a total score ranges from 8 to 40. Lower scores indicate less sleep disturbance. Negative changes in scores indicate improvement.

22. Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 [Baseline, Days 8 and 14]

    PROMIS-Sleep Related Impairment (PROMIS-SRI) scale consists of 8 items to evaluate daytime consequences of functioning 5-point Likert scale ranging from 1 to 5. PROMIS-SRI measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question has five response options ranging in value from 1 to 5. To find total raw score (which range from 8 to 40) with all questions answered, sum values of response to each question. Higher score indicates greater sleep impairment.

23. Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14 [Baseline and Day 14]

    The PGI-S is a self-reported scale to measure severity of illness using a 6-point scale ranging from 1 to 6, (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, participants rated their severity on the PGI-S scale. Negative changes in scores indicate improvement.

24. Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14 [Baseline and Day 14]

    PGI-I is a self-reported scale to measure improvement in illness using a 7-point scale ranging from 1 to 7, (1=very much improved, 2=much improved, 3=improved [just enough to make a difference], 4=no change, 5=worse [just enough to make a difference], 6=much worse, 7=very much worse). Negative changes in scores indicate improvement.

25. Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case [Day 14]

    Percentage of participants who achieved at least 50% reduction from baseline in ISI total score (responders) were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, Scores are summed for a total score which ranges from 0-28. Negative changes in scores indicate improvement. ISI total score is the sum of all item scores. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28).

26. Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case [Day 14]

    Percentage of participants with remission of insomnia symptom defined as, total score of <= 10 on ISI scale. ISI is 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. 5-point Likert scale (0-4) is used to rate each item. ISI total score is the sum of all item scores. ISI total score is the sum of all item scores. Scores are summed for a total score which ranges from 0-28 and interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28).

27. Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14 [Baseline and Day 14]

    The CGI-S is a 7-point scale to measure severity of illness (1=normal [not at all ill], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants). Higher score indicates more severity. Negative changes in scores indicate improvement.

28. Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14 [Baseline and Day 14]

    The CGI-I is a 7-point scale to measure improvement in illness using a 7-point scale ranging from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity. Negative changes in scores indicate improvement.

29. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability [Up to Day 17]

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent adverse events are adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date.

30. Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest [Up to Day 17]

    Treatment-emergent serious adverse events are serious adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date. Events of special interest included: Cataplexy; Sleep paralysis; Complex sleep-related behaviors such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); Abnormal dreams; Falls.

31. Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities [Up to Day 15]

    Clinically significant vital signs (pulse, supine and standing blood pressure (systolic and diastolic), and oral, temperature) and physical abnormalities (body weight) were reported. Abnormally low parameters included pulse (bpm)- decrease value from baseline greater than or equal to (>=) 15 to <=50; Systolic BP (mmHg [Millimeter of mercury])- decrease value from baseline >=20 to <=90; Diastolic BP- decrease value from baseline >=15 to <=50; weight (Kilogram[Kg])- decrease from baseline >=7%; Body temperature (Celsius [C])- <35.5. Abnormally high parameters included pulse- increase value from baseline >=15 to >=100; Systolic BP(mmHg)- increase from baseline of >=20 to >=180; Diastolic BP- increase value from baseline >=15 to >=105; weight(Kg)- increase from baseline of >=7%; body temperature (C)- >37.5.

32. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [Up to Day 14]

    Twelve-lead ECGs were recorded in a supine position and different ECG intervals (Respiratory rate [RR], PR, time for ventricular depolarization [QRS], and total time from ventricular depolarization to complete repolarization [QT]) and heart rate was measured. This included heart rate:<=50 beats per minute (bpm) and >=100 bpm; PR interval <=120 millisecond (msec) and >=200 msec; QRS interval: <=60 msec and >=120 msec; QT interval:<=200 msec and >=500 msec.

33. Number of Participants With Clinically Significant Laboratory Abnormalities [Up to Day 15]

    Number of participants with clinically significant laboratory abnormalities were reported. Blood samples for serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, chloride, creatine Kinase, gamma glutamyl transferase, lactate dehydrogenase, phosphate, potassium, sodium), and urinalysis (bilirubin, protein) were collected for clinical laboratory testing.

34. Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score [Day 14]

    C-SSRS is a questionnaire designed to solicit occurrence, severity, frequency of suicidal ideation/behaviors using following scores: Suicidal Ideation-1:Wish to be Dead; 2:Non-specific Active Suicidal Thoughts; 3:Active Suicidal Ideation with Any Methods without Intent to Act; 4:Active Suicidal Ideation with Some Intent to Act; 5:Active Suicidal Ideation with Specific Plan/Intent; Suicidal Behavior-6:Preparatory Acts; 7:Aborted Attempt; 8:Interrupted Attempt; 9:Actual Attempt; 10:Completed Suicide. If no events qualify for score of 1-10, score 0 indicate "no event that can be assessed on basis of C-SSRS". Higher scores= greater severity.

35. Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 [Baseline, Days 2 and 14]

    The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a single item assessed on 9-point Likert scale with response options from: 1=very alert to 9=very sleepy (fighting sleep). Negative changes indicate improvement.

36. Postural Stability Measured by Ataxiameter [Day 14 (morning)]

    The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway was measured using an ataxiameter. Participants were instructed to wear a pair of thin socks for each session. Before starting a measurement, participants were asked to stand still and comfortable, with their feet approximately 10 centimeters (cm) apart and their hands in a relaxed position alongside the body and eyes closed. The total period of body sway measurement was 2 minutes.

37. Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) [Baseline and Day 14 (Morning)]

    Power of Attention is a combination of the speed scores from the three tests of attention, and is established to reflect the ability to focus attention and to process information. Power of Attention was calculated from the sum of the reaction time measured from the attentional tasks (Simple Reaction Time, Choice Reaction Time and Digit Vigilance Speed). Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration.

38. Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) [Baseline and Day 14 (Morning)]

    Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.

39. Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) [Baseline and Day 14 (Morning)]

    Quality of working memory is a combination of the scores from Spatial Working Memory and Numeric Working Memory tasks, and is established to reflect the ability to temporarily hold numeric and spatial information in memory. Sum of Spatial and Numeric Working Memory sensitivity indices (SI) (accuracy) was used to calculate the quality of working memory. The quality of working memory score was calculated from formulae that combined the accuracy scores for the original as well as the new (distractor) stimuli. The range for both the numeric working memory and spatial working memory tasks SI are -1 to 1. Smaller scores reflect poorer ability (poorer quality of working memory),larger scores reflect better ability (better quality of working memory). Total score is the sum of Spatial Working Memory and Numeric Working Memory (ranges from -2 to 2). Smaller scores reflect poorer ability (poorer quality of working memory), larger scores reflect better ability (better quality of working memory.

40. Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) [Baseline and Day 14 (Morning)]

    Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (that is an event or a name) and a negative change from baseline reflects impairment compared to baseline.

41. Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) [Baseline and Day 14 (Morning)]

    The sum of the speed measures from the two working memory tasks (Spatial and Numeric) and the two recognition tasks (Word and Picture). Speed of Memory combines reaction times from Spatial Working Memory (range:150 to 30000 millisecond [ms]), Numeric Working Memory (150 to 30000 ms), Word Recognition (250 to 30000 ms) and Picture recognition (250 to 30000 ms) tasks. The total reaction time (sum of above 4 reaction times) measures memory retrieval speed which ranges from 800 to 120000 ms. Slower reaction time reflect poorer ability and faster reaction time reflect better ability.

42. Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST [Day 14 to Day 17]

    CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. Negative change in sSOL, sWASO indicate improvement and positive change in Subjective Total Sleep Time (sTST) indicates improvement.

43. Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) [Day 14 to Day 17]

    CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality (sQUAL) and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.

44. Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) [Day 14 to Day 17]

    CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: s-nNAW. Negative change in s-nNAW indicate improvement.

45. Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 [Day 14 to Day 17]

    PWC-20 is a reliable, sensitive instrument having 20-items used to assess potential withdrawal symptoms following cessation of treatment. Items are as follows: Loss of Appetite, Nausea-Vomiting, Diarrhea, Anxiety-Nervousness, Irritability, Dysphoric Mood-Depression, Insomnia, Fatigue, Poor Coordination, Restlessness, Diaphoresis, Tremor, Dizziness, Headaches, Stiffness, Weakness, Increased Acuity Sound Smell Touch (IASST), Paresthesias, Remember, Derealization. Each item score ranges from 0 (not present)-3 (severe), where higher scores = more affected condition. Total score ranges from 0-60, where higher score indicates more affected condition. PWC-20 score was imputed as follows: sum of the non-missing items * (total number of items) / (number of items non-missing).

46. Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 [Day 17]

    The BWSQ is a 20 symptom self-reported questionnaire to investigate withdrawal symptoms. Total score is the sum of item scores. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. Participants rated the degree to which they were experiencing each symptom as either "0=No," "1=Yes-moderate" or "2=Yes-severe". The questionnaire had been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant must be a man or women of non-childbearing potential (WONCBP), 18 to 85 years of age, inclusive, on the day of signing informed consent. A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. b). Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. c). If reproductive status is questionable, additional evaluation should be considered

• Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder

• Participant must have an Insomnia Severity Index (ISI) total score greater than or equal to (>=) 15 at screening

• Participant must have an self-reported sleep onset latency (sSOL) >=45 minutes and a subjective wake after sleep onset (sWASO) >= 60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the Consensus Sleep Diary - Morning Administration (CSD-M), prior to screening polysomnography (PSG) assessments

• Participant must demonstrate a 2-night mean latency to persistent sleep (LPS) of >= 25 minutes (with neither night less than [<] 20 minutes), a 2 night mean wake after sleep onset (WASO) >= 30 minutes, and a 2 night mean total sleep time (TST) less than or equal to (=<) 6.5 hours, with neither night greater than (>) 7 hours

• Participant must be otherwise healthy or present with stable, well-controlled, chronic conditions on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening

Exclusion Criteria:

• Has history of or current clinically significant and/or unstable liver (moderate or severe hepatic impairment [Child-Pugh Score {>=} 7]) or renal insufficiency (severe renal impairment [estimated creatinine clearance below 30 mL/min]; serum creatinine >2 [milligram per deciliter] mg/dL); significant and/or unstable cardiac, vascular, pulmonary (example, acute or severe respiratory failure), gastrointestinal, endocrine, neurologic (example, myasthenia gravis, narcolepsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the participant's condition or affect the participant's safety during the study (eg, medically frail participant with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary

• Has uncontrolled hypertension (supine systolic blood pressure >150 millimeter of mercury (mm Hg) in adult participants or >160 mm Hg in elderly participants or supine diastolic blood pressure >90 mm Hg, despite diet, exercise, or a stable dose of allowed antihypertensive therapy) at screening or Day 1. (A participant with hypertension may be included if the participant's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months)

• Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Participants with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c [HbA1c] =< 8 percent [%]) may be eligible to participate if otherwise medically healthy. It is expected that laboratory values will generally be within the normal range, though minor deviations, which are not considered to be of clinical significance to both the investigator and the sponsor's Safety Physician, are acceptable

• Has clinically significant ECG abnormalities at screening or Day 1 prior to randomization defined as:

1. QT interval corrected according to Fridericia's formula: >= 450 millisecond (msec) (males); >= 470 msec (females).

2. Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval >210 msec, left bundle branch block.

3. Features of new ischemia.

4. Other clinically important arrhythmia

• Has significant hypersomnia not related to night time insomnia (based on clinical judgment of the investigator)

• Regularly naps more than 3 times per week

• Has a current diagnosis or recent history of psychotic disorder, major depressive disorder (MDD), bipolar disorder, or posttraumatic stress disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the participant's ability to participate in the trial

• Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1. Participants with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan within the past 6 months, should be carefully screened for current suicidal ideation and only participants with non-serious items (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion of the investigator

• Has insomnia related to restless leg syndrome (RLS) (defined as periodic leg movement [PLM]-arousal index of >=10 PLM-related electroencephalograph (EEG) arousals per hour of sleep for adult participants or >15 for elderly participants), sleep breathing disorder (defined as an apnea hypopnea index >=10 cumulative apneas and hypopneas per hour of EEG sleep for adult participants or >15 for elderly participants), or parasomnias. These disorders will be ruled out by the first PSG recording during Part 2 of screening

• Has known allergies, hypersensitivity, intolerance, lack of response, or any contraindication to JNJ-42847922 or zolpidem or their excipients

• Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this study or within 1 month after the last dose of study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Preferred Research Partners	Little Rock	Arkansas	United States	72211
2	Woodland Research Northwest	Rogers	Arkansas	United States	72758
3	California Research Trials DBA Orange Country Research Institute	Anaheim	California	United States	92801
4	Excell Research Inc	Oceanside	California	United States	92056
5	Artemis Institute for Clinical Research	San Diego	California	United States	92103
6	Empire Clinical Research, LLC	Upland	California	United States	91786
7	St. Francis Medical Institute	Clearwater	Florida	United States	33765-2103
8	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
9	Sarkis Clinical Trials	Lake City	Florida	United States	32025
10	Innovative Clinical Research, Inc.	Lauderhill	Florida	United States	33319
11	Suncoast Research Group	Miami	Florida	United States	33135
12	Renstar Medical Research	Ocala	Florida	United States	34471
13	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
14	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
15	NeuroTrials Research, Inc.	Atlanta	Georgia	United States	30342
16	Chicago Research Center	Chicago	Illinois	United States	60634
17	Centennial Medical Group	Elkridge	Maryland	United States	21075
18	Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89104
19	Gastonia Medical Specialty Clinic	Gastonia	North Carolina	United States	28054
20	Clinical Research of Lake Norman	Mooresville	North Carolina	United States	28117
21	CTI Clinical Trial and Consulting Services	Cincinnati	Ohio	United States	45242
22	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
23	Clinical Research of Charleston	Mount Pleasant	South Carolina	United States	29464
24	FutureSearch Trials of Neurology, LP	Austin	Texas	United States	78731
25	Anima	Alken		Belgium	3570
26	Cliniques Universitaires Saint-Luc	Bruxelles		Belgium	1200
27	Universitair Ziekenhuis Gent	Gent		Belgium	9000
28	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
29	Universiteit Antwerpen	Wilrijk		Belgium	2610
30	CHU de Grenoble - Hôpital Albert Michallon	Isere		France	38043
31	Hopital de La Croix Rousse	Lyon Cedex 4		France	69004
32	Hôpital Hôtel Dieu - Paris	Paris		France	75181
33	Centre Hospitalier Specialisé de Rouffach	Rouffach		France	68250
34	Advanced Sleep Research GmbH	Berlin		Germany	10117
35	Emovis GmbH	Berlin		Germany	10629
36	Synexus Clinical Research GmbH	Frankfurt		Germany	60313
37	CTC North GmbH & Co. KG	Hamburg		Germany	20251
38	Synexus Clinical Research GmbH	Sachsen		Germany	04103
39	Somni Bene GmbH	Schwerin		Germany	19053
40	Klinische Forschung Schwerin GmbH	Schwerin		Germany	19055
41	SOUSEIKAI PS Clinic	Fukuoka-shi		Japan	812-0025
42	You Ariyoshi Sleep Clinic	Kitakyushu-shi		Japan	802-0084
43	Takedakai Kochi Kagamigawa Hospital	Kochi-shi		Japan	780-8037
44	Kurume University Hospital	Kurume-shi		Japan	830-0011
45	National Hospital Organization Nagoya Medical Center	Nagoya-shi		Japan	460-0001
46	Gokeikai Osaka Kaisei Hospital	Osaka-shi		Japan	532-0003
47	Wellness Boyodai Hospital	Otaru-shi		Japan	047-0155
48	Suimin Sogo Care Clinic Yoyogi	Shibuya-ku		Japan	151-0053
49	Shinjuku Research Park Clinic	Shinjuku-ku		Japan	169-0073
50	Sekino Hospital	Toshima-ku		Japan	171-0014
51	Mie University Hospital	Tsu-shi		Japan	514-8507
52	Kaiseikai Kita Shin Yokohama Internal Medicine Clinic	Yokohama-shi		Japan	223-0059
53	Centrum Badań Klinicznych PI-House sp. z o.o.	Gdansk		Poland	80-546
54	NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'	Katowice		Poland	40-123
55	Osrodek Badan Klinicznych CROMED	Poznan		Poland	60-782
56	EMC Instytut Medyczny SA	Wroclaw		Poland	50-220

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Jul 25, 2018
• Statistical Analysis Plan - Apr 22, 2019

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03375203
• Other Study ID Numbers: CR108427; 42847922ISM2005; 2017-000980-33
• First Posted: Dec 15, 2017
• Last Update Posted: May 23, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Zolpidem

Study Results

Participant Flow

Pre-assignment Detail

Total of 365 participants were randomized and 364 participants were treated. 1 participant was randomized in error, never received any study drug and was excluded from the analyses. Among 364 treated participants,1 participant randomized to JNJ-42847922 10 mg group, received 5 mg of JNJ-42847922 and was summarized under 5 mg group for safety analyses, and under 10 mg dose group for all other analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Period Title: Overall Study
STARTED	75	72	74	71	73
COMPLETED	69	68	72	69	69
NOT COMPLETED	6	4	2	2	4

Baseline Characteristics

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem	Total
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Total of all reporting groups
Overall Participants	75	71	74	71	73	364
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.6 (11.49)	56.9 (13.85)	57.6 (12.9)	57.6 (11.88)	58.5 (12.03)	57.8 (12.4)
Age, Customized (Count of Participants)
Children (2-11 years)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Adolescents (12-17 years)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Adults (18-64 years)	50 66.7%	45 63.4%	48 64.9%	47 66.2%	48 65.8%	238 65.4%
From 65 to 84 years	25 33.3%	26 36.6%	26 35.1%	24 33.8%	25 34.2%	126 34.6%
85 years and over	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	45 60%	48 67.6%	51 68.9%	50 70.4%	52 71.2%	246 67.6%
Male	30 40%	23 32.4%	23 31.1%	21 29.6%	21 28.8%	118 32.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 17.3%	13 18.3%	10 13.5%	7 9.9%	10 13.7%	53 14.6%
Not Hispanic or Latino	62 82.7%	58 81.7%	63 85.1%	64 90.1%	63 86.3%	310 85.2%
Unknown or Not Reported	0 0%	0 0%	1 1.4%	0 0%	0 0%	1 0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.3%	1 1.4%	0 0%	0 0%	1 1.4%	3 0.8%
Asian	8 10.7%	5 7%	7 9.5%	4 5.6%	6 8.2%	30 8.2%
Native Hawaiian or Other Pacific Islander	1 1.3%	0 0%	0 0%	3 4.2%	0 0%	4 1.1%
Black or African American	11 14.7%	15 21.1%	20 27%	18 25.4%	9 12.3%	73 20.1%
White	54 72%	49 69%	46 62.2%	45 63.4%	57 78.1%	251 69%
More than one race	0 0%	0 0%	1 1.4%	0 0%	0 0%	1 0.3%
Unknown or Not Reported	0 0%	1 1.4%	0 0%	1 1.4%	0 0%	2 0.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1
Description	Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.
Time Frame	Baseline and Night 1

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	71	73	71	73
Mean (Standard Deviation) [Minutes]	-15.24 (78.547)	-29.92 (49.049)	-49.49 (53.216)	-47.69 (48.423)	-40.74 (54.395)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-42847922 5 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	= 0.346
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Back-transformed Least Square Mean Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 90%; 0.70 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-42847922 10 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	= 0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Back-transformed Least Square Mean Ratio
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 90%; 0.51 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-42847922 20 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Back-transformed Least Square Mean Ratio
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 90%; 0.41 to 0.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-42847922 5 mg, JNJ-42847922 10 mg, JNJ-42847922 20 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	MCP-mod
	Comments

2. Secondary Outcome

Title	Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1
Description	PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 1. Negative changes in WASO indicate improvement.
Time Frame	Baseline and over first 6 hours on Night 1

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	71	73
Mean (Standard Deviation) [Minutes]	-15.05 (57.485)	-22.70 (45.904)	-42.57 (40.011)	-44.69 (42.823)	-29.04 (46.779)

3. Secondary Outcome

Title	Change From Baseline in LPS as Measured by PSG on Night 13
Description	LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. Negative changes in LPS indicate improvement.
Time Frame	Baseline and Night 13

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	69	73	69	69
Mean (Standard Deviation) [Minutes]	-23.74 (61.790)	-27.12 (54.726)	-53.99 (60.292)	-41.19 (59.713)	-30.94 (60.236)

4. Secondary Outcome

Title	Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13
Description	PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 13. Negative changes in WASO indicate improvement.
Time Frame	Baseline and over first 6 hours on Night 13

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	68	69	73	68	69
Mean (Standard Deviation) [Minutes]	-17.80 (52.369)	-14.63 (57.207)	-30.74 (52.835)	-38.40 (53.661)	-20.22 (46.465)

5. Secondary Outcome

Title	Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13
Description	TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.
Time Frame	Baseline, Over 6 hours on Nights 1 and 13

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	71	73	71	73
Night 1	25.50 (72.146)	43.26 (50.771)	76.47 (50.711)	80.49 (56.216)	53.70 (57.688)
Night 13	33.16 (71.488)	39.80 (66.556)	66.03 (62.995)	67.66 (66.254)	35.84 (64.950)

6. Secondary Outcome

Title	Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13
Description	TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.
Time Frame	Baseline, Over 8 hours on Nights 1 and 13

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	71	73	71	73
Night 1	37.03 (86.539)	47.85 (64.499)	81.20 (60.607)	81.07 (71.581)	63.88 (59.115)
Night 13	38.45 (83.177)	45.72 (72.640)	64.84 (77.358)	64.27 (82.377)	39.26 (77.773)

7. Secondary Outcome

Title	Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13
Description	Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percentage). Positive changes in SE indicate improvement.
Time Frame	Baseline, Nights 1 and 13

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	71	73	71	73
Night 1	7.74 (18.031)	10.18 (12.818)	16.92 (12.626)	16.86 (14.963)	13.29 (12.317)
Night 13	7.99 (17.322)	9.51 (15.154)	13.67 (16.037)	13.56 (17.199)	8.27 (16.323)

8. Secondary Outcome

Title	Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
Description	Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement.
Time Frame	Baseline, Days 1 and 13 (Hours 1 to 8)

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	71	73
WASO (hour 1): Day 1	-3.40 (13.074)	-3.55 (10.510)	-3.44 (12.969)	-6.37 (14.213)	-5.40 (12.086)
WASO (hour 1): Day 13	0.43 (12.083)	-4.78 (8.824)	-7.05 (14.569)	-7.47 (13.004)	-4.90 (11.821)
WASO (hour 2): Day 1	1.06 (18.481)	-5.72 (11.817)	-9.62 (16.721)	-10.82 (13.658)	-7.68 (14.812)
WASO (hour 2):Day 13	1.11 (18.504)	-4.12 (14.596)	-9.04 (17.034)	-9.64 (14.963)	-4.37 (16.883)
WASO (hour 3): Day 1	-5.57 (18.316)	-3.91 (12.037)	-11.05 (13.272)	-9.64 (13.055)	-9.62 (14.141)
WASO (hour 3): Day 13	-5.70 (17.681)	-0.31 (18.562)	-8.10 (12.446)	-6.99 (15.331)	-5.12 (18.140)
WASO (hour 4): Day 1	-5.33 (17.109)	-4.73 (13.193)	-9.67 (14.495)	-9.74 (14.727)	-6.23 (16.471)
WASO (hour 4): Day 13	-5.49 (18.185)	-3.47 (16.754)	-9.57 (14.483)	-6.21 (14.140)	-7.00 (15.727)
WASO (hour 5): Day 1	-3.36 (22.284)	-6.16 (15.820)	-7.53 (14.371)	-7.44 (15.834)	-4.34 (16.150)
WASO (hour 5): Day 13	-4.96 (22.597)	-4.06 (20.776)	-5.34 (20.232)	-7.97 (17.016)	-5.03 (16.306)
WASO (hour 6): Day 1	-1.06 (17.258)	-4.46 (22.383)	-5.44 (17.510)	-7.78 (18.348)	-1.46 (19.965)
WASO (hour 6): Day 13	-4.69 (19.658)	-3.09 (21.426)	0.56 (22.721)	-7.37 (20.872)	0.84 (20.768)
WASO (hour 7): Day 1	-5.01 (22.247)	-5.71 (19.784)	-3.84 (16.756)	-1.61 (19.349)	-6.15 (13.756)
WASO (hour 7): Day 13	-3.57 (21.828)	-4.92 (18.271)	-1.50 (21.145)	1.16 (23.642)	-0.75 (18.096)
WASO (hour 8): Day 1	-7.52 (23.369)	0.66 (21.311)	-0.65 (22.278)	1.25 (22.046)	-3.95 (20.149)
WASO (hour 8): Day 13	-1.73 (24.898)	-0.63 (20.118)	1.88 (23.845)	1.24 (20.858)	-3.22 (22.343)

9. Secondary Outcome

Title	Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13
Description	PSG was used to measure the number of night-time awakenings over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement.
Time Frame	Baseline, Over 6 hours on Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	71	73
Day 1	-2.08 (6.412)	-0.87 (7.224)	0.14 (7.385)	-0.94 (9.102)	-1.14 (8.727)
Day 13	-2.02 (6.928)	0.93 (7.769)	-0.40 (8.352)	-2.13 (7.542)	-0.57 (7.803)

10. Secondary Outcome

Title	Change From Baseline in Wake During Total Sleep Period on Day 1 and 13
Description	PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement.
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	71	73
Day 1	-13.79 (63.082)	-27.47 (58.188)	-49.64 (47.106)	-52.25 (40.828)	-32.36 (53.737)
Day 13	-18.83 (59.005)	-19.79 (60.626)	-42.57 (53.867)	-41.95 (64.846)	-20.58 (56.799)

11. Secondary Outcome

Title	Change From Baseline in Wake After Final Awakening on Day 1 and 13
Description	PSG was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement.
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	71	73
Day 1	-13.63 (50.958)	-0.28 (29.552)	2.80 (38.492)	7.21 (45.189)	-5.40 (29.473)
Day 13	-5.32 (55.112)	-0.39 (31.519)	12.42 (62.515)	5.62 (48.641)	-2.17 (29.376)

12. Secondary Outcome

Title	Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13
Description	PSG was used to measure number of night time awakenings per hour. Negative changes in nNAW/hr indicate improvement.
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	71	73
Day 1	-0.35 (1.069)	-0.14 (1.204)	0.02 (1.231)	-0.16 (1.517)	-0.19 (1.455)
Day 13	-0.34 (1.155)	0.16 (1.295)	-0.07 (1.392)	-0.36 (1.257)	-0.10 (1.300)

13. Secondary Outcome

Title	Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13
Description	PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement.
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	70	73
Day 1	12.05 (57.535)	10.71 (61.015)	23.11 (73.749)	53.90 (92.802)	35.63 (74.617)
Day 13	11.08 (45.714)	32.13 (70.549)	33.12 (71.826)	48.92 (88.909)	27.55 (75.080)

14. Secondary Outcome

Title	Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13
Description	PSG was used to measure REM duration (time to first REM period from sleep onset).
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	71	73	71	73
Day 1	10.32 (24.366)	10.23 (28.891)	25.12 (29.495)	23.79 (31.175)	5.41 (22.381)
Day 13	5.70 (29.875)	6.40 (25.188)	17.42 (28.699)	12.91 (32.051)	5.97 (28.811)

15. Secondary Outcome

Title	Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13
Description	PSG was used to measure the REM latency. REM latency was defined as the time to first REM from sleep onset to reaching the first epoch of REM sleep.
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	73	70	73	70	72
Day 1	-26.60 (82.487)	-38.06 (79.396)	-85.61 (84.380)	-88.36 (76.551)	-42.73 (67.024)
Day 13	-26.41 (87.903)	-32.11 (86.623)	-83.89 (83.313)	-73.40 (81.747)	-31.59 (64.953)

16. Secondary Outcome

Title	Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13
Description	PSG was used to measure the sleep-onset REM in participants. REM sleep periods within 15 minutes from sleep onset were measured.
Time Frame	Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	71	73	71	73
Day 1	1.3 1.7%	4.2 5.9%	9.6 13%	14.1 19.9%	0 0%
Day 13	1.4 1.9%	2.9 4.1%	4.1 5.5%	8.7 12.3%	2.9 4%

17. Secondary Outcome

Title	Change From Baseline in Number of Sleep Cycles on Day 1 and 13
Description	PSG was used to measure the number of sleep cycles.
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	71	73	71	73
Day 1	0.43 (1.138)	0.40 (1.006)	0.97 (1.049)	0.75 (1.155)	0.62 (0.941)
Day 13	0.20 (1.222)	0.41 (1.062)	0.77 (1.182)	0.45 (1.219)	0.32 (0.955)

18. Secondary Outcome

Title	Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13
Description	PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Total time spent was sum of N1, N2 and N3. Positive changes in NREM duration indicate improvement.
Time Frame	Baseline, Day 1 and 13

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	71	73	71	73
Day 1	27.87 (68.202)	37.62 (49.817)	56.08 (45.218)	57.29 (54.245)	58.47 (52.803)
Day 13	32.74 (61.726)	39.33 (61.524)	47.41 (59.791)	51.37 (59.310)	33.28 (62.466)

19. Secondary Outcome

Title	Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
Description	CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement.
Time Frame	Baseline, Days 2 and 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	71	66	68	69	68
sSOL: Day 2	15.20 (61.761)	-3.99 (46.858)	-16.49 (42.699)	-27.60 (34.456)	-24.98 (30.395)
sSOL: Day 14	10.92 (68.201)	-8.81 (45.936)	-31.33 (36.888)	-33.93 (37.274)	-14.53 (53.705)
sWASO: Day 2	0.81 (75.475)	-5.47 (61.067)	-18.54 (51.301)	-13.28 (48.225)	-15.99 (84.549)
sWASO : Day 14	-5.60 (55.955)	-18.25 (56.719)	-25.20 (58.872)	-20.16 (65.568)	-17.56 (51.007)
sTST: Day 2	-12.64 (96.051)	4.90 (92.105)	29.25 (67.934)	34.50 (76.904)	37.07 (71.297)
sTST: Day 14	3.30 (89.019)	29.34 (83.772)	36.79 (88.379)	45.35 (81.983)	27.68 (90.387)

20. Secondary Outcome

Title	Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
Description	The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality (sQUAL) and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.
Time Frame	Baseline, Days 2 and 14

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	71	66	68	69	68
sFRESH: Day 2	0.07 (0.930)	0.14 (0.865)	0.34 (0.852)	0.58 (1.050)	0.41 (0.876)
sFRESH: Day 14	0.26 (0.826)	0.39 (1.081)	0.51 (1.005)	0.59 (1.018)	0.41 (1.051)
sQUAL: Day 2	0.11 (0.995)	0.14 (1.054)	0.49 (0.896)	0.49 (1.091)	0.66 (0.818)
sQUAL: Day 14	0.26 (1.024)	0.43 (1.172)	0.79 (1.189)	0.67 (1.159)	0.52 (1.084)

21. Secondary Outcome

Title	Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW)
Description	CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. CSD-M parameters analyzed include: s-nNAW. Negative change in s-nNAW indicate improvement.
Time Frame	Baseline, Days 2 and 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	71	66	68	69	68
Day 2	0.64 (2.197)	0.21 (1.465)	0.49 (1.465)	0.27 (1.418)	0.38 (6.076)
Day 14	0.10 (1.234)	0.04 (1.580)	0.05 (1.320)	-0.02 (1.175)	-0.22 (1.376)

22. Secondary Outcome

Title	Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14
Description	PROMIS Sleep Disturbance (PROMIS-SD) Short Form subscale consists of a static 8-item questionnaire. Using a recall period of the past 7 days, it assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Each question has 5 response options ranging in value from 1 to 5. To find the total raw score for a short form with all questions answered, sum the values of the response to each question and a total score ranges from 8 to 40. Lower scores indicate less sleep disturbance. Negative changes in scores indicate improvement.
Time Frame	Baseline, Days 8 and 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	63	60	66	63	66
Day 8	-4.9 (6.81)	-9.0 (7.13)	-9.2 (7.17)	-9.6 (8.16)	-8.3 (7.31)
Day 14	-5.7 (7.75)	-10.8 (7.64)	-10.3 (7.39)	-9.5 (7.93)	-10.1 (8.06)

23. Secondary Outcome

Title	Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14
Description	PROMIS-Sleep Related Impairment (PROMIS-SRI) scale consists of 8 items to evaluate daytime consequences of functioning 5-point Likert scale ranging from 1 to 5. PROMIS-SRI measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question has five response options ranging in value from 1 to 5. To find total raw score (which range from 8 to 40) with all questions answered, sum values of response to each question. Higher score indicates greater sleep impairment.
Time Frame	Baseline, Days 8 and 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	61	59	63	62	65
Day 8	-4.0 (6.56)	-7.0 (6.15)	-5.5 (6.55)	-8.8 (7.09)	-4.9 (6.98)
Day 14	-5.2 (6.88)	-9.1 (6.53)	-6.3 (6.94)	-7.8 (6.98)	-7.4 (6.35)

24. Secondary Outcome

Title	Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14
Description	The PGI-S is a self-reported scale to measure severity of illness using a 6-point scale ranging from 1 to 6, (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, participants rated their severity on the PGI-S scale. Negative changes in scores indicate improvement.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	59	59	65	62	65
Median (Full Range) [Unit on a Scale]	0.00 (-5.0)	-1.00 (-4.0)	-1.00 (-4.0)	-1.00 (-5.0)	-1.00 (-4.0)

25. Secondary Outcome

Title	Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14
Description	PGI-I is a self-reported scale to measure improvement in illness using a 7-point scale ranging from 1 to 7, (1=very much improved, 2=much improved, 3=improved [just enough to make a difference], 4=no change, 5=worse [just enough to make a difference], 6=much worse, 7=very much worse). Negative changes in scores indicate improvement.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	60	62	69	65	67
Median (Full Range) [Units on a Scale]	3.00 (0.0)	2.00 (0.0)	2.00 (0.0)	2.00 (0.0)	2.00 (0.0)

26. Secondary Outcome

Title	Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case
Description	Percentage of participants who achieved at least 50% reduction from baseline in ISI total score (responders) were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, Scores are summed for a total score which ranges from 0-28. Negative changes in scores indicate improvement. ISI total score is the sum of all item scores. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number participants evaluable for this outcome measure. Participants with missing values at a given time point were excluded from frequency calculation for that time point.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	69	73	69	70
Number [percentage of participants]	23.2 30.9%	42.0 59.2%	31.5 42.6%	34.8 49%	42.9 58.8%

27. Secondary Outcome

Title	Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case
Description	Percentage of participants with remission of insomnia symptom defined as, total score of <= 10 on ISI scale. ISI is 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. 5-point Likert scale (0-4) is used to rate each item. ISI total score is the sum of all item scores. ISI total score is the sum of all item scores. Scores are summed for a total score which ranges from 0-28 and interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28).
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Participants with missing values at a given time point are excluded from the frequency calculation for that time point.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	69	73	69	70
Number [percentage of participants]	24.6 32.8%	43.5 61.3%	37.0 50%	39.1 55.1%	50.0 68.5%

28. Secondary Outcome

Title	Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14
Description	The CGI-S is a 7-point scale to measure severity of illness (1=normal [not at all ill], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants). Higher score indicates more severity. Negative changes in scores indicate improvement.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	69	73	69	70
Median (Full Range) [Units on a scale]	0.0	-1.0	-1.0	-1.0	-1.0

29. Secondary Outcome

Title	Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14
Description	The CGI-I is a 7-point scale to measure improvement in illness using a 7-point scale ranging from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity. Negative changes in scores indicate improvement.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	69	73	69	70
Median (Full Range) [Units on a Scale]	3.0	3.0	3.0	3.0	2.0

30. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
Description	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent adverse events are adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date.
Time Frame	Up to Day 17

Outcome Measure Data

Analysis Population Description

Safety analysis set (SAS) included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	72	73	71	73
Count of Participants [Participants]	37 49.3%	29 40.8%	23 31.1%	21 29.6%	31 42.5%

31. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest
Description	Treatment-emergent serious adverse events are serious adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date. Events of special interest included: Cataplexy; Sleep paralysis; Complex sleep-related behaviors such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); Abnormal dreams; Falls.
Time Frame	Up to Day 17

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	72	73	71	73
Treatment-emergent Serious AE	0 0%	0 0%	0 0%	1 1.4%	1 1.4%
Events of Special Interest	2 2.7%	1 1.4%	2 2.7%	1 1.4%	4 5.5%

32. Secondary Outcome

Title	Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Description	Clinically significant vital signs (pulse, supine and standing blood pressure (systolic and diastolic), and oral, temperature) and physical abnormalities (body weight) were reported. Abnormally low parameters included pulse (bpm)- decrease value from baseline greater than or equal to (>=) 15 to <=50; Systolic BP (mmHg [Millimeter of mercury])- decrease value from baseline >=20 to <=90; Diastolic BP- decrease value from baseline >=15 to <=50; weight (Kilogram[Kg])- decrease from baseline >=7%; Body temperature (Celsius [C])- <35.5. Abnormally high parameters included pulse- increase value from baseline >=15 to >=100; Systolic BP(mmHg)- increase from baseline of >=20 to >=180; Diastolic BP- increase value from baseline >=15 to >=105; weight(Kg)- increase from baseline of >=7%; body temperature (C)- >37.5.
Time Frame	Up to Day 15

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	75	72	73	71	73
Supine Pulse Rate: Abnormally low	2 2.7%	2 2.8%	2 2.7%	3 4.2%	0 0%
Supine Pulse Rate: Abnormally high	1 1.3%	0 0%	0 0%	0 0%	1 1.4%
Standing Pulse Rate: Abnormally low	1 1.3%	0 0%	0 0%	1 1.4%	1 1.4%
Standing Pulse Rate: Abnormally high	8 10.7%	7 9.9%	3 4.1%	6 8.5%	11 15.1%
Supine Systolic BP: Abnormally low	3 4%	0 0%	3 4.1%	2 2.8%	2 2.7%
Supine Systolic BP: Abnormally high	1 1.3%	0 0%	0 0%	0 0%	0 0%
Standing Systolic BP: Abnormally low	2 2.7%	1 1.4%	1 1.4%	3 4.2%	5 6.8%
Standing Systolic BP: Abnormally high	2 2.7%	0 0%	0 0%	0 0%	0 0%
Supine Diastolic BP: Abnormally low	2 2.7%	0 0%	0 0%	0 0%	4 5.5%
Supine Diastolic BP: Abnormally high	0 0%	1 1.4%	0 0%	0 0%	1 1.4%
Standing Diastolic BP: Abnormally low	0 0%	1 1.4%	0 0%	1 1.4%	0 0%
Standing Diastolic BP: Abnormally high	0 0%	0 0%	0 0%	0 0%	1 1.4%
Temperature: Abnormally low	2 2.7%	3 4.2%	0 0%	3 4.2%	2 2.7%
Temperature: Abnormally high	1 1.3%	0 0%	0 0%	2 2.8%	1 1.4%
Weight: Abnormally low	0 0%	0 0%	0 0%	0 0%	0 0%
Weight: Abnormally high	2 2.7%	0 0%	0 0%	1 1.4%	0 0%

33. Secondary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description	Twelve-lead ECGs were recorded in a supine position and different ECG intervals (Respiratory rate [RR], PR, time for ventricular depolarization [QRS], and total time from ventricular depolarization to complete repolarization [QT]) and heart rate was measured. This included heart rate:<=50 beats per minute (bpm) and >=100 bpm; PR interval <=120 millisecond (msec) and >=200 msec; QRS interval: <=60 msec and >=120 msec; QT interval:<=200 msec and >=500 msec.
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	74	70	71	68	71
Heart rate: <=50 bpm	10 13.3%	7 9.9%	5 6.8%	6 8.5%	6 8.2%
Heart rate:>=100 bpm	0 0%	0 0%	0 0%	0 0%	0 0%
PR interval: <=120 msec	0 0%	0 0%	0 0%	1 1.4%	0 0%
PR interval: >=200 msec	4 5.3%	4 5.6%	4 5.4%	2 2.8%	7 9.6%
QRS interval: <=60 msec	0 0%	0 0%	0 0%	0 0%	0 0%
QRS interval: >=120 msec	0 0%	0 0%	0 0%	0 0%	0 0%
QT interval: <=200 msec	0 0%	0 0%	0 0%	0 0%	0 0%
QT interval: >=500 msec	1 1.3%	0 0%	0 0%	1 1.4%	0 0%

34. Secondary Outcome

Title	Number of Participants With Clinically Significant Laboratory Abnormalities
Description	Number of participants with clinically significant laboratory abnormalities were reported. Blood samples for serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, chloride, creatine Kinase, gamma glutamyl transferase, lactate dehydrogenase, phosphate, potassium, sodium), and urinalysis (bilirubin, protein) were collected for clinical laboratory testing.
Time Frame	Up to Day 15

Outcome Measure Data

Analysis Population Description

Analysis population was SAS. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here,'n' (number analyzed) signifies number of participants who were evaluable for specified categories. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922.This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	70	71	68	71
Alanine Aminotransferase: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Albumin: Abnormally low	0 0%	0 0%	0 0%	0 0%	0 0%
Albumin: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Aspartate Aminotransferase: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Bicarbonate: Abnormally low	0 0%	0 0%	0 0%	0 0%	0 0%
Bicarbonate: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Bilirubin: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Calcium: Abnormally low	0 0%	0 0%	0 0%	0 0%	0 0%
Calcium: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Chloride: Abnormally low	1 1.3%	0 0%	0 0%	0 0%	0 0%
Chloride: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Creatine Kinase: Abnormally high	0 0%	1 1.4%	0 0%	0 0%	0 0%
Creatinine: Abnormally high	0 0%	1 1.4%	0 0%	0 0%	0 0%
Direct Bilirubin: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Gamma Glutamyl Transferase: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Lactate Dehydrogenase: Abnormally high	0 0%	0 0%	1 1.4%	0 0%	0 0%
Phosphate: Abnormally low	0 0%	0 0%	0 0%	0 0%	0 0%
Phosphate: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%
Potassium: Abnormally low	0 0%	0 0%	0 0%	0 0%	0 0%
Potassium: Abnormally high	0 0%	0 0%	3 4.1%	1 1.4%	2 2.7%
Protein: Abnormally low	0 0%	1 1.4%	0 0%	0 0%	0 0%
Sodium: Abnormally low	0 0%	0 0%	0 0%	0 0%	0 0%
Sodium: Abnormally high	0 0%	0 0%	0 0%	0 0%	0 0%

35. Secondary Outcome

Title	Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
Description	C-SSRS is a questionnaire designed to solicit occurrence, severity, frequency of suicidal ideation/behaviors using following scores: Suicidal Ideation-1:Wish to be Dead; 2:Non-specific Active Suicidal Thoughts; 3:Active Suicidal Ideation with Any Methods without Intent to Act; 4:Active Suicidal Ideation with Some Intent to Act; 5:Active Suicidal Ideation with Specific Plan/Intent; Suicidal Behavior-6:Preparatory Acts; 7:Aborted Attempt; 8:Interrupted Attempt; 9:Actual Attempt; 10:Completed Suicide. If no events qualify for score of 1-10, score 0 indicate "no event that can be assessed on basis of C-SSRS". Higher scores= greater severity.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to drug and received at least 1 dose of drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	70	72	69	70
Score 0: No Event	69 92%	70 98.6%	72 97.3%	69 97.2%	70 95.9%
Score 1: Wish to be Dead	0 0%	0 0%	0 0%	0 0%	0 0%
Score 2: Non-Specific Active Suicidal Thoughts	0 0%	0 0%	0 0%	0 0%	0 0%
Score 3: Suicidal Ideation Without Plan and Intent	0 0%	0 0%	0 0%	0 0%	0 0%
Score 4: Suicidal Ideation Intent to Act Without Plan	0 0%	0 0%	0 0%	0 0%	0 0%
Score 5: Suicidal Ideation With Plan and Intent	0 0%	0 0%	0 0%	0 0%	0 0%
Score 6: Preparatory Acts or Behavior	0 0%	0 0%	0 0%	0 0%	0 0%
Score 7: Aborted Attempt	0 0%	0 0%	0 0%	0 0%	0 0%
Score 8: Interrupted Attempt	0 0%	0 0%	0 0%	0 0%	0 0%
Score 9: Actual Attempt	0 0%	0 0%	0 0%	0 0%	0 0%
Score 10: Completed Suicide	0 0%	0 0%	0 0%	0 0%	0 0%

36. Secondary Outcome

Title	Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14
Description	The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a single item assessed on 9-point Likert scale with response options from: 1=very alert to 9=very sleepy (fighting sleep). Negative changes indicate improvement.
Time Frame	Baseline, Days 2 and 14

Outcome Measure Data

Analysis Population Description

Analysis population was SAS. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	66	62	65	59	67
Day 2	0.3 (1.75)	-0.4 (1.86)	-0.2 (1.42)	-0.5 (1.86)	-0.4 (1.68)
Day 14	0.1 (1.82)	-0.8 (2.15)	-0.6 (1.72)	-0.7 (1.90)	-0.7 (2.01)

37. Secondary Outcome

Title	Postural Stability Measured by Ataxiameter
Description	The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway was measured using an ataxiameter. Participants were instructed to wear a pair of thin socks for each session. Before starting a measurement, participants were asked to stand still and comfortable, with their feet approximately 10 centimeters (cm) apart and their hands in a relaxed position alongside the body and eyes closed. The total period of body sway measurement was 2 minutes.
Time Frame	Day 14 (morning)

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	66	66	69	67	69
Mean (Standard Deviation) [1/3 Degree Angle of Arc]	-0.06 (17.15)	3.14 (16.14)	-0.87 (15.62)	-0.25 (14.71)	1.65 (14.11)

38. Secondary Outcome

Title	Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Description	Power of Attention is a combination of the speed scores from the three tests of attention, and is established to reflect the ability to focus attention and to process information. Power of Attention was calculated from the sum of the reaction time measured from the attentional tasks (Simple Reaction Time, Choice Reaction Time and Digit Vigilance Speed). Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration.
Time Frame	Baseline and Day 14 (Morning)

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	67	66	68	67	69
Mean (Standard Deviation) [milliseconds (ms)]	35.88 (125.43)	48.59 (137.75)	67.09 (257.67)	37.07 (124.23)	35.38 (189.99)

39. Secondary Outcome

Title	Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Description	Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.
Time Frame	Baseline and Day 14 (Morning)

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	67	66	68	67	69
Mean (Standard Deviation) [units on a scale]	0.36 (5.31)	-0.20 (3.16)	-1.37 (6.35)	0.10 (5.05)	-0.39 (5.14)

40. Secondary Outcome

Title	Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Description	Quality of working memory is a combination of the scores from Spatial Working Memory and Numeric Working Memory tasks, and is established to reflect the ability to temporarily hold numeric and spatial information in memory. Sum of Spatial and Numeric Working Memory sensitivity indices (SI) (accuracy) was used to calculate the quality of working memory. The quality of working memory score was calculated from formulae that combined the accuracy scores for the original as well as the new (distractor) stimuli. The range for both the numeric working memory and spatial working memory tasks SI are -1 to 1. Smaller scores reflect poorer ability (poorer quality of working memory),larger scores reflect better ability (better quality of working memory). Total score is the sum of Spatial Working Memory and Numeric Working Memory (ranges from -2 to 2). Smaller scores reflect poorer ability (poorer quality of working memory), larger scores reflect better ability (better quality of working memory.
Time Frame	Baseline and Day 14 (Morning)

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	67	65	68	67	69
Mean (Standard Deviation) [Units on scale]	0.00 (0.35)	-0.03 (0.28)	-0.02 (0.41)	-0.04 (0.29)	0.05 (0.28)

41. Secondary Outcome

Title	Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Description	Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (that is an event or a name) and a negative change from baseline reflects impairment compared to baseline.
Time Frame	Baseline and Day 14 (Morning)

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant is summarized under the 5 mg dose group. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	66	65	68	66	67
Mean (Standard Deviation) [units on scale]	-22.84 (53.73)	-23.15 (46.02)	-33.58 (48.82)	-25.45 (56.37)	-37.96 (55.94)

42. Secondary Outcome

Title	Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Description	The sum of the speed measures from the two working memory tasks (Spatial and Numeric) and the two recognition tasks (Word and Picture). Speed of Memory combines reaction times from Spatial Working Memory (range:150 to 30000 millisecond [ms]), Numeric Working Memory (150 to 30000 ms), Word Recognition (250 to 30000 ms) and Picture recognition (250 to 30000 ms) tasks. The total reaction time (sum of above 4 reaction times) measures memory retrieval speed which ranges from 800 to 120000 ms. Slower reaction time reflect poorer ability and faster reaction time reflect better ability.
Time Frame	Baseline and Day 14 (Morning)

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	67	65	68	67	69
Mean (Standard Deviation) [millisecond]	-104.75 (787.74)	258.38 (719.56)	7.57 (806.27)	-65.67 (761.77)	-83.70 (1060.38)

43. Secondary Outcome

Title	Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST
Description	CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. Negative change in sSOL, sWASO indicate improvement and positive change in Subjective Total Sleep Time (sTST) indicates improvement.
Time Frame	Day 14 to Day 17

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	63	58	57	56	58
sSOL	-20.56 (74.145)	-4.83 (43.769)	9.67 (29.798)	15.55 (32.327)	9.57 (72.253)
sWASO	-12.39 (57.711)	-0.76 (66.663)	-2.13 (41.505)	-10.80 (63.672)	3.76 (58.805)
sTST	30.95 (101.367)	13.07 (102.093)	6.96 (96.664)	19.71 (66.447)	-7.95 (102.183)

44. Secondary Outcome

Title	Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
Description	CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality (sQUAL) and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.
Time Frame	Day 14 to Day 17

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	63	58	57	56	58
sFRESH	0.13 (1.085)	0.17 (1.011)	0.04 (1.017)	0.11 (1.073)	-0.03 (0.898)
sQUAL	0.19 (1.242)	0.24 (1.129)	-0.07 (1.083)	0.02 (1.120)	-0.12 (1.010)

45. Secondary Outcome

Title	Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW)
Description	CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: s-nNAW. Negative change in s-nNAW indicate improvement.
Time Frame	Day 14 to Day 17

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	63	58	57	56	58
Mean (Standard Deviation) [awakenings]	0.16 (3.525)	-0.59 (2.009)	-0.35 (1.217)	-0.36 (1.052)	-0.34 (1.396)

46. Secondary Outcome

Title	Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
Description	PWC-20 is a reliable, sensitive instrument having 20-items used to assess potential withdrawal symptoms following cessation of treatment. Items are as follows: Loss of Appetite, Nausea-Vomiting, Diarrhea, Anxiety-Nervousness, Irritability, Dysphoric Mood-Depression, Insomnia, Fatigue, Poor Coordination, Restlessness, Diaphoresis, Tremor, Dizziness, Headaches, Stiffness, Weakness, Increased Acuity Sound Smell Touch (IASST), Paresthesias, Remember, Derealization. Each item score ranges from 0 (not present)-3 (severe), where higher scores = more affected condition. Total score ranges from 0-60, where higher score indicates more affected condition. PWC-20 score was imputed as follows: sum of the non-missing items * (total number of items) / (number of items non-missing).
Time Frame	Day 14 to Day 17

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	69	69	70	68	69
Loss of Appetite: No Symptoms	65 86.7%	69 97.2%	65 87.8%	68 95.8%	66 90.4%
Loss of Appetite: Improved Symptoms	0 0%	0 0%	4 5.4%	0 0%	1 1.4%
Loss of Appetite: Symptoms Present and Unchanged	0 0%	0 0%	0 0%	0 0%	0 0%
Loss of Appetite: New or Worsened Symptoms	4 5.3%	0 0%	1 1.4%	0 0%	2 2.7%
Nausea-Vomiting: No Symptoms	67 89.3%	67 94.4%	66 89.2%	67 94.4%	63 86.3%
Nausea-Vomiting: Improved Symptoms	0 0%	1 1.4%	3 4.1%	0 0%	5 6.8%
Nausea-Vomiting: Symptoms Present and Unchanged	0 0%	0 0%	0 0%	0 0%	1 1.4%
Nausea-Vomiting: New or Worsened Symptoms	2 2.7%	1 1.4%	1 1.4%	1 1.4%	0 0%
Diarrhea: No Symptoms	65 86.7%	69 97.2%	67 90.5%	67 94.4%	63 86.3%
Diarrhea: Improved Symptoms	2 2.7%	0 0%	1 1.4%	1 1.4%	4 5.5%
Diarrhea: Symptoms Present and Unchanged	0 0%	0 0%	1 1.4%	0 0%	0 0%
Diarrhea: New or Worsened Symptoms	2 2.7%	0 0%	1 1.4%	0 0%	2 2.7%
Anxiety-Nervousness: No Symptoms	64 85.3%	68 95.8%	64 86.5%	62 87.3%	62 84.9%
Anxiety-Nervousness:Improved Symptoms	2 2.7%	1 1.4%	3 4.1%	3 4.2%	5 6.8%
Anxiety-Nervousness:Symptoms Present and Unchanged	2 2.7%	0 0%	1 1.4%	2 2.8%	0 0%
Anxiety-Nervousness: New or Worsened Symptoms	1 1.3%	0 0%	2 2.7%	1 1.4%	2 2.7%
Irritability: No Symptoms	58 77.3%	58 81.7%	59 79.7%	60 84.5%	58 79.5%
Irritability:Improved Symptoms	6 8%	9 12.7%	5 6.8%	4 5.6%	9 12.3%
Irritability:Symptoms Present and Unchanged	3 4%	1 1.4%	3 4.1%	3 4.2%	0 0%
Irritability:New or Worsened Symptoms	2 2.7%	1 1.4%	3 4.1%	1 1.4%	2 2.7%
Dysphoric Mood: No Symptoms	66 88%	66 93%	68 91.9%	65 91.5%	66 90.4%
Dysphoric Mood: Improved Symptoms	0 0%	3 4.2%	1 1.4%	1 1.4%	1 1.4%
Dysphoric Mood: Symptoms Present and Unchanged	2 2.7%	0 0%	1 1.4%	1 1.4%	0 0%
Dysphoric Mood: New or Worsened Symptoms	1 1.3%	0 0%	0 0%	1 1.4%	2 2.7%
Insomnia: No Symptoms	12 16%	14 19.7%	11 14.9%	17 23.9%	16 21.9%
Insomnia: Improved Symptoms	19 25.3%	15 21.1%	13 17.6%	11 15.5%	15 20.5%
Insomnia: Symptoms Present and Unchanged	27 36%	28 39.4%	32 43.2%	28 39.4%	21 28.8%
Insomnia: New or Worsened Symptoms	11 14.7%	12 16.9%	14 18.9%	12 16.9%	17 23.3%
Fatigue: No Symptoms	30 40%	43 60.6%	41 55.4%	45 63.4%	44 60.3%
Fatigue: Improved Symptoms	21 28%	15 21.1%	19 25.7%	8 11.3%	14 19.2%
Fatigue: Symptoms Present and Unchanged	5 6.7%	7 9.9%	8 10.8%	9 12.7%	5 6.8%
Fatigue: New or Worsened Symptoms	13 17.3%	4 5.6%	2 2.7%	6 8.5%	6 8.2%
Poor Coordination: No Symptoms	61 81.3%	65 91.5%	63 85.1%	61 85.9%	61 83.6%
Poor Coordination: Improved Symptoms	6 8%	3 4.2%	7 9.5%	5 7%	5 6.8%
Poor Coordination: Symptoms Present and Unchanged	1 1.3%	1 1.4%	0 0%	1 1.4%	1 1.4%
Poor Coordination: New/Worsened Symptoms	1 1.3%	0 0%	0 0%	1 1.4%	2 2.7%
Restlessness:No Symptoms	55 73.3%	59 83.1%	59 79.7%	60 84.5%	60 82.2%
Restlessness:Improved Symptoms	9 12%	6 8.5%	9 12.2%	5 7%	7 9.6%
Restlessness:Symptoms Present and Unchanged	3 4%	2 2.8%	1 1.4%	1 1.4%	1 1.4%
Restlessness:New or Worsened Symptoms	2 2.7%	2 2.8%	1 1.4%	2 2.8%	1 1.4%
Diaphoresis:No Symptoms	64 85.3%	68 95.8%	65 87.8%	65 91.5%	64 87.7%
Diaphoresis:Improved Symptoms	3 4%	1 1.4%	2 2.7%	2 2.8%	2 2.7%
Diaphoresis:Symptoms Present and Unchanged	0 0%	0 0%	0 0%	0 0%	1 1.4%
Diaphoresis:New or Worsened Symptoms	2 2.7%	0 0%	3 4.1%	1 1.4%	2 2.7%
Tremor: No Symptoms	66 88%	68 95.8%	69 93.2%	68 95.8%	67 91.8%
Tremor: Improved Symptoms	2 2.7%	0 0%	0 0%	0 0%	0 0%
Tremor: Symptoms Present and Unchanged	0 0%	1 1.4%	0 0%	0 0%	0 0%
Tremor: New or Worsened Symptoms	1 1.3%	0 0%	1 1.4%	0 0%	2 2.7%
Dizziness:No Symptoms	63 84%	69 97.2%	66 89.2%	64 90.1%	60 82.2%
Dizziness: Improved Symptoms	3 4%	0 0%	2 2.7%	3 4.2%	7 9.6%
Dizziness: Symptoms Present and Unchanged	1 1.3%	0 0%	1 1.4%	1 1.4%	1 1.4%
Dizziness:New or Worsened Symptoms	2 2.7%	0 0%	1 1.4%	0 0%	1 1.4%
Headaches:No Symptoms	56 74.7%	51 71.8%	61 82.4%	60 84.5%	56 76.7%
Headaches:Improved Symptoms	9 12%	12 16.9%	4 5.4%	7 9.9%	3 4.1%
Headaches:Symptoms Present and Unchanged	2 2.7%	5 7%	3 4.1%	0 0%	3 4.1%
Headaches:New or Worsened Symptoms	2 2.7%	1 1.4%	2 2.7%	1 1.4%	7 9.6%
Stiffness:No Symptoms	59 78.7%	62 87.3%	64 86.5%	63 88.7%	59 80.8%
Stiffness:Improved Symptoms	8 10.7%	2 2.8%	2 2.7%	3 4.2%	3 4.1%
Stiffness:Symptoms Present and Unchanged	1 1.3%	2 2.8%	2 2.7%	0 0%	1 1.4%
Stiffness:New or Worsened Symptoms	1 1.3%	3 4.2%	2 2.7%	2 2.8%	6 8.2%
Weakness:No Symptoms	61 81.3%	69 97.2%	65 87.8%	65 91.5%	65 89%
Weakness:Improved Symptoms	3 4%	0 0%	3 4.1%	3 4.2%	2 2.7%
Weakness:Symptoms Present and Unchanged	3 4%	0 0%	1 1.4%	0 0%	0 0%
Weakness:New or Worsened Symptoms	2 2.7%	0 0%	1 1.4%	0 0%	2 2.7%
IASST: No Symptoms	64 85.3%	66 93%	66 89.2%	63 88.7%	62 84.9%
IASST: Improved Symptoms	1 1.3%	1 1.4%	1 1.4%	3 4.2%	2 2.7%
IASST: Symptoms Present and Unchanged	2 2.7%	1 1.4%	0 0%	0 0%	1 1.4%
IASST: New or Worsened Symptoms	2 2.7%	1 1.4%	3 4.1%	2 2.8%	4 5.5%
Paresthesias:No Symptoms	62 82.7%	68 95.8%	66 89.2%	68 95.8%	68 93.2%
Paresthesias:Improved Symptoms	4 5.3%	0 0%	2 2.7%	0 0%	0 0%
Paresthesias:Symptoms Present and Unchanged	1 1.3%	1 1.4%	0 0%	0 0%	0 0%
Paresthesias:New or Worsened Symptoms	2 2.7%	0 0%	2 2.7%	0 0%	1 1.4%
Remember:No Symptoms	50 66.7%	60 84.5%	56 75.7%	56 78.9%	53 72.6%
Remember:Improved Symptoms	9 12%	7 9.9%	9 12.2%	8 11.3%	6 8.2%
Remember:Symptoms Present and Unchanged	5 6.7%	1 1.4%	4 5.4%	1 1.4%	5 6.8%
Remember:New or Worsened Symptoms	5 6.7%	1 1.4%	1 1.4%	3 4.2%	5 6.8%
Derealization:No Symptoms	64 85.3%	68 95.8%	68 91.9%	67 94.4%	68 93.2%
Derealization:Improved Symptoms	4 5.3%	1 1.4%	1 1.4%	1 1.4%	1 1.4%
Derealization:Symptoms Present and Unchanged	0 0%	0 0%	0 0%	0 0%	0 0%
Derealization:New or Worsened Symptoms	1 1.3%	0 0%	1 1.4%	0 0%	0 0%

47. Secondary Outcome

Title	Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17
Description	The BWSQ is a 20 symptom self-reported questionnaire to investigate withdrawal symptoms. Total score is the sum of item scores. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. Participants rated the degree to which they were experiencing each symptom as either "0=No," "1=Yes-moderate" or "2=Yes-severe". The questionnaire had been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms.
Time Frame	Day 17

Outcome Measure Data

Analysis Population Description

SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participant analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.

Arm/Group Title	Placebo	JNJ-42847922 5 mg	JNJ-42847922 10 mg	JNJ-42847922 20 mg	Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.	Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
Measure Participants	58	54	56	51	55
Mean (Standard Deviation) [Units on a Scale]	1.5 (2.58)	1.2 (1.90)	2.0 (3.44)	1.5 (2.93)	2.0 (3.10)

Adverse Events

Time Frame	Up to Day 17
Adverse Event Reporting Description	Safety analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
Arm/Group Title	Placebo		JNJ-42847922 5 mg		JNJ-42847922 10 mg		JNJ-42847922 20 mg		Zolpidem
Arm/Group Description	Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.		Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.		Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.		Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.		Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
All Cause Mortality
	Placebo		JNJ-42847922 5 mg		JNJ-42847922 10 mg		JNJ-42847922 20 mg		Zolpidem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/72 (0%)		0/73 (0%)		0/71 (0%)		0/73 (0%)
Serious Adverse Events
	Placebo		JNJ-42847922 5 mg		JNJ-42847922 10 mg		JNJ-42847922 20 mg		Zolpidem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/72 (0%)		0/73 (0%)		1/71 (1.4%)		1/73 (1.4%)
Nervous system disorders
Cerebral Haemorrhage	0/75 (0%)	0	0/72 (0%)	0	0/73 (0%)	0	1/71 (1.4%)	1	0/73 (0%)	0
Cognitive Disorder	0/75 (0%)	0	0/72 (0%)	0	0/73 (0%)	0	0/71 (0%)	0	1/73 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Placebo		JNJ-42847922 5 mg		JNJ-42847922 10 mg		JNJ-42847922 20 mg		Zolpidem
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/75 (29.3%)		16/72 (22.2%)		10/73 (13.7%)		13/71 (18.3%)		21/73 (28.8%)
Gastrointestinal disorders
Diarrhoea	3/75 (4%)	4	0/72 (0%)	0	0/73 (0%)	0	1/71 (1.4%)	1	4/73 (5.5%)	4
Nausea	2/75 (2.7%)	2	1/72 (1.4%)	1	2/73 (2.7%)	2	0/71 (0%)	0	5/73 (6.8%)	5
General disorders
Fatigue	8/75 (10.7%)	8	4/72 (5.6%)	4	3/73 (4.1%)	3	2/71 (2.8%)	2	2/73 (2.7%)	2
Infections and infestations
Nasopharyngitis	1/75 (1.3%)	1	4/72 (5.6%)	4	1/73 (1.4%)	1	0/71 (0%)	0	1/73 (1.4%)	1
Urinary Tract Infection	4/75 (5.3%)	4	0/72 (0%)	0	1/73 (1.4%)	1	1/71 (1.4%)	1	0/73 (0%)	0
Musculoskeletal and connective tissue disorders
Myalgia	3/75 (4%)	4	1/72 (1.4%)	1	1/73 (1.4%)	1	0/71 (0%)	0	4/73 (5.5%)	4
Nervous system disorders
Disturbance in Attention	4/75 (5.3%)	4	2/72 (2.8%)	2	1/73 (1.4%)	1	1/71 (1.4%)	1	4/73 (5.5%)	4
Dizziness	1/75 (1.3%)	1	0/72 (0%)	0	0/73 (0%)	0	0/71 (0%)	0	5/73 (6.8%)	7
Headache	8/75 (10.7%)	8	7/72 (9.7%)	8	4/73 (5.5%)	6	6/71 (8.5%)	8	8/73 (11%)	10
Somnolence	1/75 (1.3%)	1	1/72 (1.4%)	1	0/73 (0%)	0	4/71 (5.6%)	4	4/73 (5.5%)	5
Psychiatric disorders
Restlessness	4/75 (5.3%)	4	0/72 (0%)	0	2/73 (2.7%)	2	2/71 (2.8%)	2	1/73 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.