• Kathryn M Connor, Erin Mahoney, Saheeda Jackson, Jill Hutzelmann, Xin Zhao, Nan Jia, Ellen Snyder, Duane Snavely, David Michelson, Thomas Roth, and W Joseph Herring.
• Merck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.) kathryn.connor@merck.com.
• Int. J. Neuropsychopharmacol. 2016 Aug 1; 19 (8).

BackgroundFilorexant (MK-6096) is an orexin receptor antagonist; here, we evaluate the efficacy of filorexant in the treatment of insomnia in adults.MethodsA double-blind, placebo-controlled, randomized, two 4-week-period, adaptive crossover polysomnography study was conducted at 51 sites worldwide. Patients (18 to <65 years) with insomnia received 1 of 4 doses of oral filorexant (2.5, 5, 10, 20mg) once daily at bedtime during one period and matching placebo in the other period in 1 of 8 possible treatment sequences. Polysomnography was performed on night 1 and end of week 4 of each period. The primary endpoint was sleep efficiency at night 1 and end of week 4. Secondary endpoints included wakefulness after persistent sleep onset and latency to onset of persistent sleep.ResultsA total of 324 patients received study treatment, 315 received ≥1 dose of placebo, and 318 ≥1 dose of filorexant (2.5mg, n=79; 5mg, n=78; 10mg, n=80; 20mg, n=81). All filorexant doses (2.5/5/10/20mg) were significantly superior to placebo in improving sleep among patients with insomnia as measured by sleep efficiency and wakefulness after persistent sleep onset on night 1 and end of week 4. The 2 higher filorexant doses (10/20mg) were also significantly more effective than placebo in improving sleep onset as measured by latency to onset of persistent sleep at night 1 and end of week 4. Filorexant was generally well tolerated.ConclusionsOrexin receptor antagonism by filorexant significantly improved sleep efficiency in nonelderly patients with insomnia. Dose-related improvements in sleep onset and maintenance outcomes were also observed with filorexant.© The Author 2016. Published by Oxford University Press on behalf of CINP.

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