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A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

Sponsor
Eisai Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01463098
Collaborator
(none)
122
Enrollment
2
Locations
14
Arms
10.2
Actual Duration (Months)
61
Patients Per Site
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects.

Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.

Condition or Disease Intervention/Treatment Phase
  • Drug: E2006 1.0 mg
  • Drug: E2006 2.5 mg
  • Drug: E2006 5.0 mg
  • Drug: E2006 10.0 mg
  • Drug: E2006 25.0 mg
  • Drug: E2006 50.0 mg
  • Drug: E2006 100 mg
  • Drug: E2006 200 mg
  • Drug: Zolpidem 10 mg
  • Drug: E2006 Matched Placebo or Zolpidem Matched Placebo
  • Drug: E2006 Matched Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 2-Part, Randomized, Double-Blind, Placebo- and Active- Controlled, Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Subjects and Otherwise Healthy Subjects With Primary Insomnia
Actual Study Start Date :
Oct 5, 2011
Actual Primary Completion Date :
Aug 11, 2012
Actual Study Completion Date :
Aug 11, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: E2006 1.0 mg

Drug: E2006 1.0 mg
E2006 1.0 mg capsule.
Other Names:
  • Lemborexant

    		•
    Experimental: Part A: E2006 2.5 mg

    Drug: E2006 2.5 mg
    E2006 2.5 mg capsule.
    Other Names:
  • Lemborexant

    		•
    Experimental: Part A: E2006 5.0 mg

    Drug: E2006 5.0 mg
    E2006 5.0 mg (2 capsules of 2.5 mg each).
    Other Names:
  • Lemborexant

    		•
    Experimental: Part A: E2006 10.0 mg

    Drug: E2006 10.0 mg
    E2006 10.0 mg capsule.
    Other Names:
  • Lemborexant

    		•
    Experimental: Part A: E2006 25.0 mg

    Drug: E2006 25.0 mg
    E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).
    Other Names:
  • Lemborexant

    		•
    Experimental: Part A: E2006 50.0 mg

    Drug: E2006 50.0 mg
    E2006 50.0 mg capsule.
    Other Names:
  • Lemborexant

    		•
    Experimental: Part A: E2006 100 mg

    Drug: E2006 100 mg
    E2006 100 mg (2 capsules of 50 mg each).
    Other Names:
  • Lemborexant

    		•
    Experimental: Part A: E2006 200 mg

    Drug: E2006 200 mg
    E2006 200 mg (4 capsules of 50 mg each).
    Other Names:
  • Lemborexant

    		•
    Experimental: Part B: Zolpidem 10 mg

    Drug: Zolpidem 10 mg
    Zolpidem 10 mg immediate release tablet.
    Experimental: Part B: E2006 Matched Placebo or Zolpidem Matched Placebo

    Drug: E2006 Matched Placebo or Zolpidem Matched Placebo
    E2006-matched placebo capsules or zolpidem-matched placebo tablets.
    Experimental: Part A: E2006 Matched Placebo

    Drug: E2006 Matched Placebo
    E2006-matched placebo capsule.
    Experimental: Part B: E2006 2.5 mg

    Drug: E2006 2.5 mg
    E2006 2.5 mg capsule.
    Other Names:
  • Lemborexant

    		•
    Experimental: Part B: E2006 10 mg

    Drug: E2006 10.0 mg
    E2006 10.0 mg capsule.
    Other Names:
  • Lemborexant

    		•
    Experimental: Part B: E2006 25 mg

    Drug: E2006 25.0 mg
    E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).
    Other Names:
  • Lemborexant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) [Baseline up to Day 11]

    2. Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values [Baseline up to Day 6]

    3. Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values [Baseline up to Day 11]

    4. Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values [Baseline up to Day 11]

    5. Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline, Day 11]

      The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of Participants with any suicidality has been reported for this outcome measure.

    6. Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 [Baseline, Day 1]

      LPS was the duration of time in minutes from lights off to the first 30 seconds of recording (epoch) of 20 consecutive epochs of non-wakefulness as measured by PSG.

    7. Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 [Baseline, Day 1]

      TST was the duration in minutes including rapid eye movement (REM) sleep plus non-rapid eye movement (NREM) sleep during the time spent in bed.

    8. Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 [Baseline, Day 1]

      Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.

    9. Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 [Baseline, Day 1]

      WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on.

    10. Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 [Baseline, Day 1]

      Number of awakenings was determined from LPS to lights-on. LPS was the duration of time measured from lights off to the first 30 seconds of PSG measurement recording (epoch) of 20 consecutive epochs of non-wake. An awakening was defined as a PSG recording of at least two consecutive wake epochs.

    11. Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 [Baseline, Day 1]

      Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.

    12. Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 [Baseline, Day 1]

      Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.

    13. Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 [Baseline, Day 1]

      Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.

    14. Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "How long did you sleep last night" has been reported.

    15. Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Time to fall asleep last night" has been reported.

    16. Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Number of awakening after falling asleep" has been reported.

    17. Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Time spent awake after falling asleep" has been reported.

    18. Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Rate quality of your sleep" has been reported.

    19. Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 [Day 1 (Pre-dose), Day 6]

      DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function.

    20. Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 [Day 1 (Pre-dose), Day 6]

      PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment.

    21. Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 [Day 1 (Pre-dose), Day 6]

      KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 9, which indicates "extremely sleepy, can't stay awake". Higher numbers indicating sleepier and lower numbers more alert.

    Secondary Outcome Measures

    1. Part A: Maximum Plasma Concentration (Cmax) of E2006 [Day 1: Pre-dose, up to 240 hours post-dose]

    2. Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 [Day 1: Pre-dose, up to 240 hours post-dose]

    3. Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 [Day 1: Pre-dose, up to 240 hours post-dose]

    4. Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 [Day 1: Pre-dose, up to 240 hours post-dose]

    5. Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 [Day 1: Pre-dose, up to 240 hours post-dose]

    6. Part A: Terminal Half-life (t1/2) of E2006 in Plasma [Day 1: Pre-dose, up to 240 hours post-dose]

    7. Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) [Day 1: Pre-dose, up to 240 hours post-dose]

    8. Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) [Day 1: Pre-dose, up to 240 hours post-dose]

    9. Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) [Day 1: Pre-dose, up to 120 hours post-dose]

    10. Part A: Renal Clearance (CLR) of Drug E2006 [Day 1: Pre-dose, up to 120 hours post-dose]

    11. Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 [Day 1 (Pre-dose), up to Day 6]

      DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.

    12. Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 [Day 1 (Pre-dose), Day 6]

      PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.

    13. Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 [Day 1 (Pre-dose), Day 6]

      KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 9, which indicates "extremely sleepy, can't stay awake". Higher numbers indicating sleepier and lower numbers more alert. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.

    14. Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "How long did you sleep last night" has been reported.

    15. Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Time to fall asleep last night" has been reported.

    16. Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Number of awakening after falling asleep" has been reported.

    17. Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Time spent awake after falling asleep" has been reported.

    18. Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 [Day 1, Day 6]

      Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Rate quality of your sleep" has been reported.

    19. Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) [Baseline up to Day 11]

    20. Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values [Baseline up to Day 6]

    21. Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values [Baseline up to Day 11]

    22. Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values [Baseline up to Day 11]

    23. Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline, Day 11]

      The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess any suicidality, any suicidal Behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious, behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions-wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality has been reported for this outcome measure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:
    Healthy Subjects:

    • With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800

    • Who report typical sleep latency of </= 30 minutes

    • With typical total sleep time (TST) >/= 420 minutes

    Primary Insomnia Subjects:

    • Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months

    • With a score of > 15 on the Insomnia Severity Index (ISI) at Screening

    • Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the past month

    • Who report 6.5 hours sleep or less on at least 3 nights per week for the past month

    • With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes with neither night < 15 minutes

    • With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with neither night < 15 minutes or mean TST > 420 minutes

    Key Exclusion Criteria:

    • With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)

    • Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment

    • All females must be of non-childbearing potential

    • With a known history of significant neurological or serious psychiatric illness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinilabs, Inc. New York New York United States 10019
    2 Community Research Cincinnati Ohio United States

    Sponsors and Collaborators

    • Eisai Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Inc.
    ClinicalTrials.gov Identifier:
    NCT01463098
    Other Study ID Numbers:
    • E2006-A001-001
    First Posted:
    Nov 1, 2011
    Last Update Posted:
    Jan 18, 2020
    Last Verified:
    Mar 1, 2013
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Zolpidem
    Lemborexant

    Study Results

    Participant Flow

    Recruitment Details Participants took part in the study at 2 investigative sites in United States from 05 October 2011 to 11 August 2012.
    Pre-assignment Detail Part A: A total of 160 healthy participants were screened, of which 96 were screen failures and 64 were enrolled and randomized to receive study treatment. Part B: A total of 281 otherwise healthy participants with primary insomnia were screened, of which 223 were screen failures and 58 were enrolled and randomized to receive study treatment.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 milligram (mg), capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Period Title: Part A (11 Days)
    STARTED 16 6 6 6 6 6 6 6 6 0 0 0 0 0
    COMPLETED 14 6 6 6 5 6 6 6 5 0 0 0 0 0
    NOT COMPLETED 2 0 0 0 1 0 0 0 1 0 0 0 0 0
    Period Title: Part A (11 Days)
    STARTED 0 0 0 0 0 0 0 0 0 12 11 13 10 12
    COMPLETED 0 0 0 0 0 0 0 0 0 12 11 12 10 12
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 1 0 0

    Baseline Characteristics

    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg Total
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Total of all reporting groups
    Overall Participants 16 6 6 6 6 6 6 6 6 12 11 13 10 12 122
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    16
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    12
    100%
    11
    100%
    13
    100%
    10
    100%
    12
    100%
    122
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    8
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    6
    50%
    5
    45.5%
    6
    46.2%
    4
    40%
    6
    50%
    59
    48.4%
    Male
    8
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    3
    50%
    6
    50%
    6
    54.5%
    7
    53.8%
    6
    60%
    6
    50%
    63
    51.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    12.5%
    2
    33.3%
    1
    16.7%
    2
    33.3%
    1
    16.7%
    1
    16.7%
    2
    33.3%
    3
    50%
    3
    50%
    0
    0%
    0
    0%
    1
    7.7%
    0
    0%
    0
    0%
    18
    14.8%
    Not Hispanic or Latino
    14
    87.5%
    4
    66.7%
    5
    83.3%
    4
    66.7%
    5
    83.3%
    5
    83.3%
    4
    66.7%
    3
    50%
    3
    50%
    12
    100%
    11
    100%
    12
    92.3%
    10
    100%
    12
    100%
    104
    85.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    10%
    0
    0%
    2
    1.6%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    0
    0%
    0
    0%
    0
    0%
    3
    2.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Black or African American
    6
    37.5%
    3
    50%
    2
    33.3%
    3
    50%
    2
    33.3%
    4
    66.7%
    2
    33.3%
    2
    33.3%
    2
    33.3%
    6
    50%
    2
    18.2%
    7
    53.8%
    4
    40%
    5
    41.7%
    50
    41%
    White
    8
    50%
    3
    50%
    3
    50%
    3
    50%
    2
    33.3%
    2
    33.3%
    2
    33.3%
    3
    50%
    4
    66.7%
    6
    50%
    8
    72.7%
    6
    46.2%
    5
    50%
    7
    58.3%
    62
    50.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    12.5%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4
    3.3%

    Outcome Measures

    1. Primary Outcome
    Title Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)
    Description
    Time Frame Baseline up to Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    AEs
    7
    43.8%
    1
    16.7%
    0
    0%
    1
    16.7%
    4
    66.7%
    2
    33.3%
    4
    66.7%
    2
    33.3%
    5
    83.3%
    SAEs
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values
    Description
    Time Frame Baseline up to Day 6

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Count of Participants [Participants]
    6
    37.5%
    1
    16.7%
    3
    50%
    1
    16.7%
    2
    33.3%
    2
    33.3%
    3
    50%
    1
    16.7%
    0
    0%
    3. Primary Outcome
    Title Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values
    Description
    Time Frame Baseline up to Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values
    Description
    Time Frame Baseline up to Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5. Primary Outcome
    Title Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
    Description The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of Participants with any suicidality has been reported for this outcome measure.
    Time Frame Baseline, Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Baseline
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 11
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6. Primary Outcome
    Title Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1
    Description LPS was the duration of time in minutes from lights off to the first 30 seconds of recording (epoch) of 20 consecutive epochs of non-wakefulness as measured by PSG.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic (PD) analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Baseline
    56.3
    (20.5)
    51.8
    (26.7)
    50.1
    (35.1)
    55.9
    (40.5)
    62.8
    (38.3)
    Change From Baseline at Day 1
    -7.17
    (30.9)
    -33.1
    (20.3)
    -28.1
    (45.2)
    -28.8
    (39.0)
    -43.9
    (35.9)
    7. Primary Outcome
    Title Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1
    Description TST was the duration in minutes including rapid eye movement (REM) sleep plus non-rapid eye movement (NREM) sleep during the time spent in bed.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Baseline
    335
    (56.2)
    349
    (49.9)
    341
    (46.7)
    345
    (60.7)
    342
    (46.9)
    Change From Baseline at Day 1
    14.0
    (47.6)
    61.3
    (41.9)
    51.9
    (60.5)
    61.8
    (34.0)
    85.8
    (49.9)
    8. Primary Outcome
    Title Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1
    Description Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Baseline
    69.8
    (11.7)
    72.7
    (10.4)
    71.1
    (9.72)
    71.9
    (12.6)
    71.3
    (9.77)
    Change From Baseline at Day 1
    2.90
    (9.93)
    12.8
    (8.73)
    10.8
    (12.6)
    12.9
    (7.08)
    17.9
    (10.4)
    9. Primary Outcome
    Title Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1
    Description WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Baseline
    95.7
    (52.9)
    85.7
    (39.6)
    95.6
    (41.5)
    84.7
    (64.0)
    85.4
    (20.7)
    Change From Baseline at Day 1
    -7.52
    (27.3)
    -32.1
    (30.7)
    -28.9
    (59.0)
    -28.3
    (53.6)
    -45.6
    (21.1)
    10. Primary Outcome
    Title Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1
    Description Number of awakenings was determined from LPS to lights-on. LPS was the duration of time measured from lights off to the first 30 seconds of PSG measurement recording (epoch) of 20 consecutive epochs of non-wake. An awakening was defined as a PSG recording of at least two consecutive wake epochs.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Baseline
    10.5
    (3.91)
    12.4
    (5.33)
    11.9
    (3.48)
    12.3
    (4.08)
    10.9
    (3.52)
    Change From Baseline at Day 1
    0.125
    (3.48)
    -3.45
    (3.08)
    -1.38
    (4.87)
    -0.30
    (6.85)
    0.542
    (4.17)
    11. Primary Outcome
    Title Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1
    Description Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Stage N1: Baseline
    11.8
    (5.74)
    10.3
    (3.47)
    15.2
    (5.70)
    11.9
    (4.44)
    11.5
    (2.54)
    Stage N1: Change at Day 1
    0.00429
    (5.29)
    -0.715
    (5.02)
    -4.28
    (6.11)
    2.19
    (4.92)
    -2.67
    (2.49)
    Stage N2: Baseline
    56.5
    (7.73)
    56.3
    (6.70)
    57.5
    (10.9)
    60.6
    (12.0)
    51.5
    (6.61)
    Stage N2: Change at Day 1
    0.390
    (4.64)
    -0.316
    (4.96)
    -0.306
    (7.49)
    -3.12
    (9.36)
    -2.73
    (5.77)
    Stage N3/Slow Wave Sleep: Baseline
    14.0
    (8.74)
    15.0
    (9.77)
    10.9
    (9.78)
    11.8
    (12.1)
    17.2
    (4.75)
    Stage N3/Slow Wave Sleep : Change at Day 1
    0.0613
    (2.90)
    2.15
    (3.77)
    -0.0852
    (6.10)
    1.01
    (8.55)
    -0.42
    (3.28)
    Stage REM: Baseline
    17.7
    (4.86)
    18.4
    (4.59)
    16.4
    (3.52)
    15.7
    (3.46)
    19.8
    (4.93)
    Stage REM: Change at Day 1
    -0.455
    (3.58)
    -1.12
    (4.13)
    4.67
    (6.54)
    -0.0712
    (7.07)
    5.82
    (5.27)
    12. Primary Outcome
    Title Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1
    Description Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Stage N1: Baseline
    37.8
    (16.6)
    35.1
    (11.3)
    50.1
    (15.5)
    40.7
    (17.3)
    38.9
    (11.0)
    Stage N1: Change at Day 1
    2.38
    (17.8)
    3.41
    (17.4)
    -7.65
    (15.0)
    14.7
    (19.9)
    -1.35
    (11.1)
    Stage N2: Baseline
    190
    (39.4)
    195
    (27.7)
    198
    (52.7)
    212
    (63.6)
    175
    (29.2)
    Stage N2: Change at Day 1
    10.4
    (34.3)
    34.4
    (33.9)
    29.6
    (52.3)
    21.5
    (38.8)
    33.6
    (36.6)
    Stage N3/Slow Wave Sleep: Baseline
    47.7
    (33.2)
    53.4
    (35.2)
    36.5
    (32.1)
    38.3
    (37.8)
    59.1
    (18.2)
    Stage N3/Slow Wave Sleep: Change at Day 1
    1.94
    (12.7)
    16.3
    (17.4)
    3.73
    (18.3)
    14.9
    (28.8)
    12.7
    (11.3)
    Stage REM: Baseline
    59.4
    (19.3)
    65.3
    (20.0)
    56.7
    (15.7)
    54.0
    (14.0)
    68.8
    (19.6)
    Stage REM: Change at Day 1
    -0.729
    (13.3)
    7.14
    (19.2)
    26.3
    (31.8)
    10.7
    (29.5)
    40.8
    (21.7)
    13. Primary Outcome
    Title Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1
    Description Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.
    Time Frame Baseline, Day 1

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Baseline
    167
    (22.3)
    168
    (35.5)
    174
    (42.2)
    188
    (45.6)
    153
    (36.7)
    Change From Baseline at Day 1
    0.250
    (35.7)
    4.18
    (41.2)
    -16.3
    (30.4)
    14.4
    (53.1)
    14.0
    (28.1)
    14. Primary Outcome
    Title Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "How long did you sleep last night" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1
    302.1
    (82.39)
    292.3
    (61.21)
    298.8
    (106.45)
    302.5
    (71.70)
    276.3
    (82.77)
    Change From Day 1 at Day 6
    -3.3
    (74.66)
    12.7
    (55.11)
    42.4
    (89.08)
    -41.5
    (87.24)
    20.0
    (60.11)
    15. Primary Outcome
    Title Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Time to fall asleep last night" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1
    70.8
    (22.55)
    67.3
    (30.36)
    72.2
    (51.99)
    82.5
    (61.02)
    108.1
    (65.00)
    Change From Day 1 at Day 6
    8.3
    (36.33)
    9.1
    (28.09)
    -3.8
    (31.37)
    46.5
    (76.63)
    -13.7
    (42.57)
    16. Primary Outcome
    Title Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Number of awakening after falling asleep" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1
    2.7
    (1.30)
    2.7
    (1.42)
    2.8
    (1.30)
    2.7
    (1.42)
    3.6
    (1.24)
    Change From Day 1 at Day 6
    -0.1
    (1.16)
    -0.3
    (1.10)
    -0.6
    (1.39)
    0.7
    (2.31)
    0.3
    (0.97)
    17. Primary Outcome
    Title Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Time spent awake after falling asleep" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1
    133.8
    (115.76)
    101.8
    (76.36)
    82.3
    (46.31)
    102.0
    (68.56)
    128.8
    (88.30)
    Change From Day 1 at Day 6
    -27.9
    (136.39)
    -5.5
    (55.70)
    -3.7
    (54.03)
    46.8
    (140.47)
    10.7
    (93.91)
    18. Primary Outcome
    Title Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Rate quality of your sleep" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1
    2.8
    (0.72)
    3.1
    (0.83)
    2.6
    (0.65)
    2.6
    (0.70)
    2.8
    (0.75)
    Change From Day 1 at Day 6
    -0.6
    (0.67)
    -0.5
    (0.93)
    -0.5
    (0.78)
    0.2
    (0.92)
    -0.4
    (1.00)
    19. Primary Outcome
    Title Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6
    Description DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function.
    Time Frame Day 1 (Pre-dose), Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1 (Pre-dose)
    53.0
    (9.56)
    50.7
    (11.64)
    48.2
    (10.80)
    51.0
    (6.48)
    49.5
    (11.87)
    Change From Day 1 (Pre-dose) at Day 6
    9.8
    (15.15)
    10.5
    (14.44)
    14.3
    (13.34)
    8.3
    (15.33)
    11.7
    (20.67)
    20. Primary Outcome
    Title Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6
    Description PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment.
    Time Frame Day 1 (Pre-dose), Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1 (Pre-dose)
    2.3
    (3.67)
    3.0
    (2.86)
    4.1
    (7.57)
    4.4
    (4.22)
    5.2
    (12.00)
    Change From Day 1 (Pre-dose) at Day 6
    0.3
    (2.49)
    2.3
    (6.84)
    0.9
    (5.33)
    -1.4
    (3.66)
    -1.2
    (9.57)
    21. Primary Outcome
    Title Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6
    Description KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 9, which indicates "extremely sleepy, can't stay awake". Higher numbers indicating sleepier and lower numbers more alert.
    Time Frame Day 1 (Pre-dose), Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Day 1 (Pre-dose)
    4.4
    (1.83)
    3.8
    (2.04)
    4.0
    (2.20)
    4.8
    (2.20)
    5.5
    (1.93)
    Change From Day 1 (Pre-dose) at Day 6
    -0.4
    (1.68)
    1.0
    (1.41)
    0.2
    (1.34)
    0.3
    (1.95)
    -0.7
    (2.27)
    22. Secondary Outcome
    Title Part A: Maximum Plasma Concentration (Cmax) of E2006
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)]
    5.15
    (27.1)
    14.9
    (43.0)
    22.3
    (19.1)
    32.0
    (57.3)
    107
    (20.3)
    161
    (32.9)
    242
    (47.0)
    429
    (12.2)
    23. Secondary Outcome
    Title Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Median (Full Range) [hours]
    1.000
    1.010
    1.550
    1.000
    2.010
    2.525
    3.000
    3.000
    24. Secondary Outcome
    Title Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameter for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [nanogram hour per milliliter (ng*h/mL)]
    17.0
    (17.5)
    53.8
    (36.4)
    93.2
    (18.9)
    150
    (38.9)
    648
    (15.4)
    1060
    (33.0)
    1850
    (33.8)
    3970
    (24.8)
    25. Secondary Outcome
    Title Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL]
    18.4
    (29.9)
    74.4
    (45.9)
    126
    (18.7)
    274
    (30.4)
    1390
    (31.3)
    1960
    (38.5)
    4300
    (35.1)
    9290
    (39.5)
    26. Secondary Outcome
    Title Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 5 4 5 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL]
    19.5
    (19.8)
    72.3
    (54.3)
    146
    (20.9)
    299
    (31.7)
    1470
    (33.7)
    2020
    (40.3)
    4520
    (36.8)
    9910
    (39.5)
    27. Secondary Outcome
    Title Part A: Terminal Half-life (t1/2) of E2006 in Plasma
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Median (Full Range) [hours]
    12.700
    30.100
    31.350
    56.150
    65.500
    51.850
    59.750
    65.200
    28. Secondary Outcome
    Title Part A: Apparent Total Clearance of E2006 From Plasma (CL/F)
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [liter per hour (L/h)]
    44.8
    (39.0)
    28.2
    (54.2)
    33.9
    (18.6)
    33.4
    (31.8)
    17.0
    (33.4)
    24.8
    (40.3)
    22.1
    (36.9)
    20.2
    (39.4)
    29. Secondary Outcome
    Title Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F)
    Description
    Time Frame Day 1: Pre-dose, up to 240 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [liter (L)]
    1170
    (40.7)
    1200
    (34.4)
    1610
    (25.3)
    2670
    (26.6)
    1580
    (24.5)
    1810
    (28.7)
    1930
    (28.1)
    1680
    (35.4)
    30. Secondary Outcome
    Title Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae)
    Description
    Time Frame Day 1: Pre-dose, up to 120 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [milligram (mg)]
    0.000108
    (28.6)
    0.0000777
    (126)
    0.000667
    (153)
    0.00141
    (47.4)
    0.00788
    (72.1)
    0.0113
    (23.1)
    0.0307
    (65.5)
    0.0402
    (56.8)
    31. Secondary Outcome
    Title Part A: Renal Clearance (CLR) of Drug E2006
    Description
    Time Frame Day 1: Pre-dose, up to 120 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.
    Arm/Group Title Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 6 6 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [milliliter per minute (mL/min)]
    0.0877
    (29.8)
    0.0157
    (70.7)
    0.0881
    (129)
    0.0938
    (68.7)
    0.111
    (66.2)
    0.107
    (34.5)
    0.140
    (44.6)
    0.0844
    (41.7)
    32. Secondary Outcome
    Title Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6
    Description DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.
    Time Frame Day 1 (Pre-dose), up to Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
    Arm/Group Title Part A: Placebo: Matched to 1, 2.5, 5 mg E2006 Part A: Placebo: Matched to 10, 25, 50, 100, 200 mg E2006 Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo (matched to 1 mg, 2.5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006-matched placebo (matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 10 6 6 6 6 6 6 6 6
    Day 1 (Pre-dose)
    53.7
    (13.84)
    59.1
    (15.27)
    52.3
    (10.33)
    63.7
    (8.57)
    61.2
    (13.53)
    60.5
    (9.97)
    59.2
    (8.06)
    59.8
    (8.80)
    56.5
    (8.57)
    62.8
    (18.93)
    Maximum Change From Day 1 (Pre-dose) at Day 6
    14.3
    (14.01)
    7.8
    (18.23)
    16.0
    (11.42)
    9.0
    (18.57)
    8.8
    (18.81)
    -9.0
    (34.71)
    5.8
    (30.01)
    2.6
    (27.57)
    -13.0
    (18.97)
    -16.3
    (34.62)
    33. Secondary Outcome
    Title Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6
    Description PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.
    Time Frame Day 1 (Pre-dose), Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
    Arm/Group Title Part A: Placebo: Matched to 1, 2.5, 5 mg E2006 Part A: Placebo: Matched to 10, 25, 50, 100, 200 mg E2006 Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo (matched to 1 mg, 2,5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006-matched placebo (matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 10 6 6 6 6 6 6 6 6
    Day 1 (Pre-dose)
    1.0
    (0.89)
    1.8
    (2.39)
    1.3
    (2.42)
    2.5
    (2.43)
    1.3
    (1.97)
    1.5
    (1.38)
    0.3
    (0.52)
    2.5
    (2.07)
    2.0
    (1.90)
    6.5
    (4.18)
    Maximum Change From Day 1 (Pre-dose) at Day 6
    6.0
    (10.70)
    4.7
    (3.37)
    3.4
    (2.07)
    1.4
    (4.45)
    2.5
    (9.33)
    22.6
    (10.45)
    19.7
    (19.50)
    26.6
    (12.42)
    29.2
    (14.13)
    32.0
    (16.63)
    34. Secondary Outcome
    Title Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6
    Description KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 9, which indicates "extremely sleepy, can't stay awake". Higher numbers indicating sleepier and lower numbers more alert. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.
    Time Frame Day 1 (Pre-dose), Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
    Arm/Group Title Part A: Placebo: Matched to 1, 2.5, 5 mg E2006 Part A: Placebo: Matched to 10, 25, 50, 100, 200 mg E2006 Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo (matched to 1 mg, 2,5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006-matched placebo (matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 6 10 6 6 6 6 6 6 6 6
    Day 1 (Pre-dose)
    5.2
    (1.83)
    2.8
    (1.48)
    3.2
    (0.98)
    3.8
    (2.04)
    3.5
    (2.88)
    3.0
    (1.10)
    2.0
    (1.10)
    2.3
    (2.07)
    2.2
    (0.98)
    2.5
    (1.52)
    Maximum Change From Day 1 (Pre-dose) at Day 6
    -0.8
    (4.02)
    0.5
    (2.95)
    0.0
    (2.55)
    -0.2
    (3.13)
    0.8
    (4.60)
    5.3
    (1.21)
    4.8
    (2.99)
    5.4
    (3.44)
    6.0
    (1.26)
    6.3
    (1.86)
    35. Secondary Outcome
    Title Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "How long did you sleep last night" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Day 1
    457.7
    (24.81)
    475.0
    (12.25)
    443.3
    (42.39)
    436.7
    (36.29)
    473.3
    (7.53)
    469.2
    (26.54)
    438.3
    (21.37)
    455.0
    (48.06)
    434.2
    (45.21)
    Change From Day 1 at Day 6
    3.0
    (29.58)
    -85.8
    (82.12)
    10.8
    (26.54)
    22.5
    (32.52)
    -4.2
    (21.54)
    -11.0
    (79.23)
    36. Secondary Outcome
    Title Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Time to fall asleep last night" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Day 1
    13.2
    (6.99)
    15.7
    (9.73)
    17.2
    (9.91)
    14.5
    (10.17)
    15.0
    (8.94)
    16.7
    (7.53)
    15.8
    (3.76)
    10.0
    (5.48)
    15.0
    (7.07)
    Change From Day 1 at Day 6
    2.1
    (10.46)
    20.0
    (39.37)
    -4.7
    (6.68)
    -3.8
    (5.49)
    4.2
    (3.76)
    7.0
    (27.93)
    37. Secondary Outcome
    Title Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Number of awakening after falling asleep" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Day 1
    1.1
    (0.77)
    1.8
    (0.75)
    1.3
    (1.03)
    0.8
    (0.75)
    0.5
    (0.84)
    1.2
    (0.98)
    0.8
    (0.98)
    1.8
    (0.41)
    1.8
    (1.72)
    Change From Day 1 at Day 6
    -0.6
    (1.24)
    1.7
    (1.97)
    0.3
    (1.51)
    0.2
    (0.41)
    -0.7
    (1.03)
    -1.0
    (1.79)
    38. Secondary Outcome
    Title Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Time spent awake after falling asleep" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Day 1
    4.6
    (4.86)
    6.2
    (3.76)
    16.8
    (22.14)
    5.3
    (7.53)
    1.7
    (2.58)
    5.0
    (4.47)
    5.0
    (6.32)
    11.2
    (5.60)
    6.7
    (4.08)
    Change From Day 1 at Day 6
    -1.9
    (8.18)
    53.3
    (53.82)
    5.0
    (8.37)
    5.0
    (4.65)
    -3.0
    (7.75)
    -2.5
    (4.37)
    39. Secondary Outcome
    Title Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6
    Description Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Rate quality of your sleep" has been reported.
    Time Frame Day 1, Day 6

    Outcome Measure Data

    Analysis Population Description
    PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
    Measure Participants 16 6 6 6 6 6 6 6 6
    Day 1
    1.1
    (0.77)
    0.3
    (0.52)
    1.5
    (1.22)
    0.7
    (0.82)
    1.0
    (0.00)
    0.5
    (0.84)
    1.0
    (0.89)
    0.8
    (0.98)
    1.5
    (0.84)
    Change From Day 1 at Day 6
    0.2
    (0.67)
    1.3
    (1.03)
    0.0
    (0.00)
    0.0
    (0.00)
    0.2
    (0.75)
    -0.2
    (1.17)
    40. Secondary Outcome
    Title Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)
    Description
    Time Frame Baseline up to Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    AEs
    1
    6.3%
    6
    100%
    2
    33.3%
    6
    100%
    6
    100%
    SAEs
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    41. Secondary Outcome
    Title Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values
    Description
    Time Frame Baseline up to Day 6

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Count of Participants [Participants]
    3
    18.8%
    6
    100%
    4
    66.7%
    3
    50%
    7
    116.7%
    42. Secondary Outcome
    Title Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values
    Description
    Time Frame Baseline up to Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    43. Secondary Outcome
    Title Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values
    Description
    Time Frame Baseline up to Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    44. Secondary Outcome
    Title Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
    Description The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess any suicidality, any suicidal Behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious, behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions-wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality has been reported for this outcome measure.
    Time Frame Baseline, Day 11

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.
    Arm/Group Title Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    Measure Participants 12 11 13 10 12
    Baseline
    2
    12.5%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 11
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Baseline up to Day 11 (for Both Part A and Part B)
    Adverse Event Reporting Description
    Arm/Group Title Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Arm/Group Description Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1. Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1. Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
    All Cause Mortality
    Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Serious Adverse Events
    Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Part A: E2006 Matched Placebo Part A: E2006 1.0 mg Part A: E2006 2.5 mg Part A: E2006 5 mg Part A: E2006 10 mg Part A: E2006 25 mg Part A: E2006 50 mg Part A: E2006 100 mg Part A: E2006 200 mg Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Part B: Zolpidem 10 mg Part B: E2006 2.5 mg Part B: E2006 10 mg Part B: E2006 25 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/16 (43.8%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 4/6 (66.7%) 2/6 (33.3%) 4/6 (66.7%) 2/6 (33.3%) 5/6 (83.3%) 1/12 (8.3%) 6/11 (54.5%) 2/13 (15.4%) 6/10 (60%) 6/12 (50%)
    Blood and lymphatic system disorders
    Leukopenia 0/16 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Cardiac disorders
    Palpitations 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Eye disorders
    Photopsia 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Photophobia 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 1/10 (10%) 0/12 (0%)
    Gastrointestinal disorders
    Constipation 1/16 (6.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 1/12 (8.3%)
    Nausea 1/16 (6.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 1/13 (7.7%) 1/10 (10%) 0/12 (0%)
    Vomiting 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 1/10 (10%) 0/12 (0%)
    Abdominal pain 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 1/10 (10%) 0/12 (0%)
    Oral disorder 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 1/10 (10%) 0/12 (0%)
    General disorders
    Application site erythema 1/16 (6.3%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Application site irritation 1/16 (6.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Application site rash 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Application site erosion 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 1/13 (7.7%) 0/10 (0%) 0/12 (0%)
    Chest discomfort 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Vessel puncture site pain 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Infections and infestations
    Gastroenteritis 1/16 (6.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Injury, poisoning and procedural complications
    Excoriation 1/16 (6.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Investigations
    Blood phosphorus decreased 1/16 (6.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Blood triglycerides increased 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    White blood cell count decreased 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Alanine aminotransferase increased 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 1/10 (10%) 0/12 (0%)
    Oxygen saturation decreased 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 2/11 (18.2%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Metabolism and nutrition disorders
    Increased appetite 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 1/13 (7.7%) 0/10 (0%) 0/12 (0%)
    Musculoskeletal and connective tissue disorders
    Muscle twitching 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Myalgia 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Nervous system disorders
    Headache 2/16 (12.5%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 1/12 (8.3%) 0/11 (0%) 0/13 (0%) 2/10 (20%) 2/12 (16.7%)
    Sinus headache 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Sleep paralysis 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 2/6 (33.3%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 1/10 (10%) 0/12 (0%)
    Somnolence 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Dizziness 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Sleep phase rhythm disturbance 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 1/10 (10%) 2/12 (16.7%)
    Psychiatric disorders
    Abnormal dreams 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Anxiety 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Hallucination 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Insomnia 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Euphoric mood 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 1/12 (8.3%)
    Hypnagogic hallucination 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Renal and urinary disorders
    Urine odour abnormal 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 1/11 (9.1%) 0/13 (0%) 0/10 (0%) 0/12 (0%)
    Skin and subcutaneous tissue disorders
    Rash 0/16 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/12 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Results Point of Contact

    Name/Title Eisai Medical Information
    Organization Eisai Inc.
    Phone +1-888-274-2378
    Email esi_medinfo@eisai.com
    Responsible Party:
    Eisai Inc.
    ClinicalTrials.gov Identifier:
    NCT01463098
    Other Study ID Numbers:
    • E2006-A001-001
    First Posted:
    Nov 1, 2011
    Last Update Posted:
    Jan 18, 2020
    Last Verified:
    Mar 1, 2013