A phase II dose-ranging study evaluating the efficacy and safety of the orexin receptor antagonist filorexant (MK-6096) in patients with primary insomnia

Kathryn M. Connor, Erin Mahoney, Saheeda Jackson, Jill Hutzelmann, Xin Zhao, Nan Jia, Ellen Snyder, Duane Snavely, David Michelson, Thomas Roth, W. Joseph Herring

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalInternational Journal of Neuropsychopharmacology
Volume19
Issue number8
DOIs
StatePublished - Aug 1 2016
Externally publishedYes

Keywords

  • Dose-ranging study
  • Filorexant
  • Insomnia
  • Orexin receptor antagonist
  • Sleep efficiency

ASJC Scopus subject areas

  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)

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    Connor, K. M., Mahoney, E., Jackson, S., Hutzelmann, J., Zhao, X., Jia, N., Snyder, E., Snavely, D., Michelson, D., Roth, T., & Herring, W. J. (2016). A phase II dose-ranging study evaluating the efficacy and safety of the orexin receptor antagonist filorexant (MK-6096) in patients with primary insomnia. International Journal of Neuropsychopharmacology, 19(8). https://doi.org/10.1093/ijnp/pyw022