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- Title
A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia.
- Authors
Connor, Kathryn M.; Mahoney, Erin; Jackson, Saheeda; Hutzelmann, Jill; Xin Zhao; Herring, W. Joseph; Nan Jia; Snyder, Ellen; Snavely, Duane; Michelson, David; Roth, Thomas
- Abstract
Background: Filorexant (MK-6096) is an orexin receptor antagonist; here, we evaluate the efficacy of filorexant in the treatment of insomnia in adults. Methods: A 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, 20 mg) 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. Results: A total of 324 patients received study treatment, 315 received ≥1 dose of placebo, and 318 ≥1 dose of filorexant (2.5 mg, n = 79; 5 mg, n = 78; 10 mg, n = 80; 20 mg, n = 81). All filorexant doses (2.5/5/10/20 mg) 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 (10/20 mg) 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. Conclusions: Orexin 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.
- Subjects
INSOMNIA treatment; DRUG efficacy; OREXINS; MEDICATION safety; DRUG antagonism; DRUG dosage; POLYSOMNOGRAPHY
- Publication
International Journal of Neuropsychopharmacology, 2016, Vol 19, Issue 8, p1
- ISSN
1461-1457
- Publication type
Article
- DOI
10.1093/ijnp/pyw022