Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Summary

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.

Timeline

Start

2008-11-05

Primary completion

2009-12-26

Completion

2009-12-26

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Suvorexant 80 mg; p <0.001; LS Mean Difference: Night 1 12.9 (95% CI 9.5 to 16.3); Mixed Models Analysis NCT00792298 ↗

paper Suvorexant showed significant (p values <0.01) dose-related improvements vs placebo on the coprimary end points of sleep efficiency at night 1 and end of week 4 PMID 23197752 ↗

Publications

• Results Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Suvorexant	Small molecule	10 mg	Oral
Subject	Suvorexant	Small molecule	20 mg	Oral
Subject	Suvorexant	Small molecule	40 mg	Oral
Subject	Suvorexant	Small molecule	80 mg	Oral

Indications