Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01021852
• Collaborator: (none)
• Enrollment: 326
• Arms: 8
• Actual Duration (Months): 14.1

Study Details

Study Description

Brief Summary

This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of 4 weeks of treatment (Week 4).

Condition or Disease	Intervention/Treatment	Phase
Primary Insomnia	Drug: MK-6096; Drug: Dose-matched Placebo to MK-6096	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 326 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-6096 in Patients With Primary Insomnia
• Actual Study Start Date: Nov 30, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MK-6096 2.5 mg/Placebo Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Experimental: Placebo/MK-6096 2.5 mg Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Experimental: MK-6096 5 mg/Placebo Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Experimental: Placebo/MK-6096 5 mg Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Experimental: MK-6096 10 mg/Placebo Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Experimental: Placebo/MK-6096 10 mg Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Experimental: MK-6096 20 mg/Placebo Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Experimental: Placebo/MK-6096 20 mg Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Drug: MK-6096; MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Drug: Dose-matched Placebo to MK-6096; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.

Outcome Measures

Primary Outcome Measures

1. Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment [Night 1 and end of Week 4]

   SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.

2. Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2 [Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)]

   An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.

3. Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2 [Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)]

   An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.

Secondary Outcome Measures

1. Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment [Night 1 and end of Week 4]

   WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. LS mean WASO was reported for each treatment arm.

2. Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment [Night 1 and end of Week 4]

   LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R&K scoring. LS mean LPS was reported for each treatment arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant is willing to stay overnight at a sleep laboratory on 6 separate nights and is willing to stay in bed for at least 8 hours each night while at the sleep laboratory

• Participant's regular bedtime is between 9 PM and 12 AM (midnight)

• Participant is able to read and complete questionnaires and diaries

• Participant is willing to refrain from napping during the study

Exclusion Criteria:

• If female, participant is breast feeding, pregnant, or planning to become pregnant

• Participant is expecting to donate eggs or sperm during the study

• Participant has any history of a neurological disorder

• Participant has a history within the past 6 months of a cardiovascular disorder such as unstable angina, congestive heart failure or acute coronary syndrome.

• Participant has difficulty sleeping due to a medical condition

• Participant has donated blood products within the 8 weeks prior to the study

• Participant plans to travel across 3 or more time zones during the study

• Participant is currently participating or has participated in a study with an investigational compound or device within the last 30 days

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01021852
• Other Study ID Numbers: 6096-011; MK-6096-011
• First Posted: Nov 30, 2009
• Last Update Posted: Nov 6, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Pre-assignment Detail	326 participants were randomized in this study into one of 8 treatment sequences. Participants received double-blind study drug in Treatment Period (TP)1, followed by a washout period (3 day single-blind placebo plus 11 day drug holiday), and then double-blind study drug in TP2.

Arm/Group Title	MK-6096 2.5 mg/Placebo	Placebo/MK-6096 2.5 mg	MK-6096 5 mg/Placebo	Placebo/MK-6096 5 mg	MK-6096 10 mg/Placebo	Placebo/MK-6096 10 mg	MK-6096 20 mg/Placebo	Placebo/MK-6096 20 mg
Arm/Group Description	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
Period Title: Treatment Period 1
STARTED	40	40	41	40	42	41	41	41
Treated	40	40	41	38	42	41	41	41
COMPLETED	37	39	39	38	39	39	41	40
NOT COMPLETED	3	1	2	2	3	2	0	1
Period Title: Treatment Period 1
STARTED	37	39	39	38	40	39	41	40
COMPLETED	37	39	39	37	39	38	40	40
NOT COMPLETED	0	0	0	1	1	1	1	0
Period Title: Treatment Period 1
STARTED	38	39	39	37	39	39	40	40
COMPLETED	37	39	39	37	39	38	40	40
NOT COMPLETED	1	0	0	0	0	1	0	0
Period Title: Treatment Period 1
STARTED	37	39	39	37	39	38	40	40
COMPLETED	37	38	38	37	37	37	37	38
NOT COMPLETED	0	1	1	0	2	1	3	2

Baseline Characteristics

Arm/Group Title	MK-6096 2.5 mg/Placebo	Placebo/MK-6096 2.5 mg	MK-6096 5 mg/Placebo	Placebo/MK-6096 5 mg	MK-6096 10 mg/Placebo	Placebo/MK-6096 10 mg	MK-6096 20 mg/Placebo	Placebo/MK-6096 20 mg	Total
Arm/Group Description	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.	Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.	Total of all reporting groups
Overall Participants	40	40	41	40	42	41	41	41	326
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.9 (11.9)	47.9 (11.7)	44.7 (10.7)	47.6 (10.4)	45.4 (9.9)	45.2 (11.0)	49.8 (9.8)	47.0 (12.3)	46.8 (11.0)
Sex: Female, Male (Count of Participants)
Female	25 62.5%	25 62.5%	26 63.4%	25 62.5%	26 61.9%	26 63.4%	25 61%	25 61%	203 62.3%
Male	15 37.5%	15 37.5%	15 36.6%	15 37.5%	16 38.1%	15 36.6%	16 39%	16 39%	123 37.7%

Outcome Measures

1. Primary Outcome

Title	Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment
Description	SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.
Time Frame	Night 1 and end of Week 4

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization SE efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.

Arm/Group Title	Placebo	MK-6096 2.5 mg	MK-6096 5 mg	MK-6096 10 mg	MK-6096 20 mg
Arm/Group Description	Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.	Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
Measure Participants	313	79	78	80	80
Night 1 (n=313, 79, 78, 80, 80)	74.8 (0.71)	83.3 (1.54)	84.8 (1.55)	85.6 (1.53)	88.2 (1.53)
Week 4 (n=300, 76, 76, 76, 75)	77.0 (0.71)	81.6 (1.42)	81.1 (1.42)	86.7 (1.43)	85.7 (1.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	MK-6096 2.5 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	8.4
	Confidence Interval	(2-Sided) 95%; 5.3 to 11.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.59
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	MK-6096 5 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	9.9
	Confidence Interval	(2-Sided) 95%; 6.8 to 13.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.59
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	MK-6096 10 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	10.7
	Confidence Interval	(2-Sided) 95%; 7.7 to 13.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.57
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	MK-6096 20 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	13.4
	Confidence Interval	(2-Sided) 95%; 10.3 to 16.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.57
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	MK-6096 2.5 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	4.6
	Confidence Interval	(2-Sided) 95%; 1.8 to 7.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.42
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	MK-6096 5 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	4.1
	Confidence Interval	(2-Sided) 95%; 1.3 to 6.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.42
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	MK-6096 10 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	9.7
	Confidence Interval	(2-Sided) 95%; 6.9 to 12.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.43
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	MK-6096 20 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	8.7
	Confidence Interval	(2-Sided) 95%; 5.9 to 11.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.43
	Estimation Comments

2. Secondary Outcome

Title	Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment
Description	WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. LS mean WASO was reported for each treatment arm.
Time Frame	Night 1 and end of Week 4

Outcome Measure Data

Analysis Population Description

FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization WASO efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.

Arm/Group Title	Placebo	MK-6096 2.5 mg	MK-6096 5 mg	MK-6096 10 mg	MK-6096 20 mg
Arm/Group Description	Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.	Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
Measure Participants	313	79	78	80	80
Night 1 (n=313, 79, 78, 80, 80)	83.1 (2.81)	52.3 (6.11)	50.6 (6.14)	52.2 (6.06)	37.3 (6.07)
Week 4 (n=300, 76, 76, 76, 75)	76.1 (2.77)	60.6 (5.62)	62.9 (5.62)	50.5 (5.63)	46.1 (5.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	MK-6096 2.5 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-30.8
	Confidence Interval	(2-Sided) 95%; -43.2 to -18.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.29
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	MK-6096 5 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-32.5
	Confidence Interval	(2-Sided) 95%; -44.9 to -20.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.31
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	MK-6096 10 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-30.9
	Confidence Interval	(2-Sided) 95%; -43.2 to -18.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.21
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	MK-6096 20 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-45.8
	Confidence Interval	(2-Sided) 95%; -58.0 to -33.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.22
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	MK-6096 2.5 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-15.5
	Confidence Interval	(2-Sided) 95%; -26.7 to -4.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.65
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	MK-6096 5 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-13.2
	Confidence Interval	(2-Sided) 95%; -24.4 to -2.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.66
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	MK-6096 10 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-25.7
	Confidence Interval	(2-Sided) 95%; -36.8 to -14.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.67
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	MK-6096 20 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-30.0
	Confidence Interval	(2-Sided) 95%; -41.2 to -18.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.69
	Estimation Comments

3. Secondary Outcome

Title	Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment
Description	LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R&K scoring. LS mean LPS was reported for each treatment arm.
Time Frame	Night 1 and end of Week 4

Outcome Measure Data

Analysis Population Description

FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization LPS efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.

Arm/Group Title	Placebo	MK-6096 2.5 mg	MK-6096 5 mg	MK-6096 10 mg	MK-6096 20 mg
Arm/Group Description	Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.	Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
Measure Participants	313	79	78	80	80
Night 1 (n=313, 79, 78, 80, 80)	43.4 (2.06)	33.2 (4.35)	27.7 (4.36)	19.9 (4.32)	23.0 (4.31)
Week 4 (n=300, 76, 76, 76, 75)	39.4 (2.19)	30.5 (4.55)	30.7 (4.55)	19.9 (4.57)	28.1 (4.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	MK-6096 2.5 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-10.2
	Confidence Interval	(2-Sided) 95%; -18.9 to -1.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.43
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	MK-6096 5 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-15.7
	Confidence Interval	(2-Sided) 95%; -24.5 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.44
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	MK-6096 10 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-23.5
	Confidence Interval	(2-Sided) 95%; -32.1 to -14.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.38
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	MK-6096 20 mg vs. Placebo at Night 1 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-20.3
	Confidence Interval	(2-Sided) 95%; -29.0 to -11.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.38
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	MK-6096 2.5 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.055
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-8.9
	Confidence Interval	(2-Sided) 95%; -18.0 to 0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.61
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	MK-6096 5 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.060
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-8.7
	Confidence Interval	(2-Sided) 95%; -17.8 to 0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.61
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	MK-6096 10 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-19.5
	Confidence Interval	(2-Sided) 95%; -28.6 to -10.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.62
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	MK-6096 20 mg vs. Placebo at Week 4 A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-11.3
	Confidence Interval	(2-Sided) 95%; -20.5 to -2.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.63
	Estimation Comments

4. Primary Outcome

Title	Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2
Description	An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.
Time Frame	Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)

Outcome Measure Data

Analysis Population Description

All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.

Arm/Group Title	Placebo	MK-6096 2.5 mg	MK-6096 5 mg	MK-6096 10 mg	MK-6096 20 mg
Arm/Group Description	Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.	Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
Measure Participants	315	79	78	80	81
Number [percentage of participants]	26.0 65%	26.6 66.5%	25.6 62.4%	32.5 81.3%	34.6 82.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -9.5 to 12.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -10.3 to 11.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; -4.2 to 18.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.5
	Confidence Interval	(2-Sided) 95%; -2.3 to 20.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2
Description	An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.
Time Frame	Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)

Outcome Measure Data

Analysis Population Description

APaT population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.

Arm/Group Title	Placebo	MK-6096 2.5 mg	MK-6096 5 mg	MK-6096 10 mg	MK-6096 20 mg
Arm/Group Description	Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.	Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.	Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
Measure Participants	315	79	78	80	81
Number [percentage of participants]	2.2 5.5%	5.1 12.8%	1.3 3.2%	2.5 6.3%	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 2.5 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; -1.0 to 10.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 5 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -3.6 to 4.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 10 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -2.7 to 6.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, MK-6096 20 mg
	Comments	Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 95%; -4.5 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	From time of first dose through follow-up (up to 86 days)
Adverse Event Reporting Description	APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
Arm/Group Title	Placebo		MK-6096 2.5 mg		MK-6096 5 mg		MK-6096 10 mg		MK-6096 20 mg		Washout		Post-Study/Follow-up
Arm/Group Description	Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.		Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.		Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.		Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.		Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.		Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.		Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
All Cause Mortality
	Placebo		MK-6096 2.5 mg		MK-6096 5 mg		MK-6096 10 mg		MK-6096 20 mg		Washout		Post-Study/Follow-up
	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	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		MK-6096 2.5 mg		MK-6096 5 mg		MK-6096 10 mg		MK-6096 20 mg		Washout		Post-Study/Follow-up
	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	0/315 (0%)		1/79 (1.3%)		1/78 (1.3%)		1/80 (1.3%)		0/81 (0%)		1/315 (0.3%)		1/324 (0.3%)
Cardiac disorders
Atrial fibrillation	0/315 (0%)	0	0/79 (0%)	0	1/78 (1.3%)	1	0/80 (0%)	0	0/81 (0%)	0	0/315 (0%)	0	0/324 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	0/315 (0%)	0	0/79 (0%)	0	0/78 (0%)	0	1/80 (1.3%)	1	0/81 (0%)	0	0/315 (0%)	0	1/324 (0.3%)	1
Infections and infestations
Periorbital cellulitis	0/315 (0%)	0	1/79 (1.3%)	1	0/78 (0%)	0	0/80 (0%)	0	0/81 (0%)	0	0/315 (0%)	0	0/324 (0%)	0
Nervous system disorders
Syncope	0/315 (0%)	0	0/79 (0%)	0	1/78 (1.3%)	1	0/80 (0%)	0	0/81 (0%)	0	0/315 (0%)	0	0/324 (0%)	0
Psychiatric disorders
Completed suicide	0/315 (0%)	0	0/79 (0%)	0	0/78 (0%)	0	0/80 (0%)	0	0/81 (0%)	0	1/315 (0.3%)	1	0/324 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		MK-6096 2.5 mg		MK-6096 5 mg		MK-6096 10 mg		MK-6096 20 mg		Washout		Post-Study/Follow-up
	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	21/315 (6.7%)		3/79 (3.8%)		5/78 (6.4%)		10/80 (12.5%)		14/81 (17.3%)		5/315 (1.6%)		0/324 (0%)
Nervous system disorders
Headache	12/315 (3.8%)	14	3/79 (3.8%)	3	3/78 (3.8%)	4	5/80 (6.3%)	5	3/81 (3.7%)	3	4/315 (1.3%)	4	0/324 (0%)	0
Somnolence	9/315 (2.9%)	9	1/79 (1.3%)	1	2/78 (2.6%)	2	5/80 (6.3%)	6	11/81 (13.6%)	13	1/315 (0.3%)	1	0/324 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.