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

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

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).

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