Suvorexant in Patients with Insomnia: Results from Two 3-Month Randomized Controlled Clinical Trials

W. Joseph Herring, Kathryn M. Connor, Neely Ivgy-May, Ellen Snyder, Ken Liu, Duane B. Snavely, Andrew D. Krystal, James K. Walsh, Ruth M. Benca, Russell Rosenberg, R. Bart Sangal, Kerry Budd, Jill Hutzelmann, Heather Leibensperger, Samar Froman, Christopher Lines, Thomas Roth, David Michelson

Research output: Contribution to journalArticle

Abstract

Background Suvorexant is an orexin receptor antagonist for treatment of insomnia. We report results from two pivotal phase 3 trials. Methods Two randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in nonelderly (18-64 years) and elderly (≥65 years) patients with insomnia. Suvorexant doses of 40/30 mg (nonelderly/elderly) and 20/15 mg (nonelderly/elderly) were evaluated. The primary focus was 40/30 mg, with fewer patients randomized to 20/15 mg. There was an optional 3-month double-blind extension in trial 1. Each trial included a 1-week, randomized, double-blind run-out after double-blind treatment to assess withdrawal/rebound. Efficacy was assessed at week 1, month 1, and month 3 by patient-reported subjective total sleep time and time to sleep onset and in a subset of patients at night 1, month 1, and month 3 by polysomnography end points of wakefulness after persistent sleep onset and latency to onset of persistent sleep (LPS). One thousand twenty-one patients were randomized in trial 1 and 1019 patients in trial 2. Results Suvorexant 40/30 mg was superior to placebo on all subjective and polysomnography end points at night 1/week 1, month 1, and month 3 in both trials, except for LPS at month 3 in trial 2. Suvorexant 20/15 mg was superior to placebo on subjective total sleep time and wakefulness after persistent sleep onset at night 1/week 1, month 1, and month 3 in both trials and at most individual time points for subjective time to sleep onset and LPS in each trial. Both doses of suvorexant were generally well tolerated, with <5% of patients discontinuing due to adverse events over 3 months. The results did not suggest the emergence of marked rebound or withdrawal signs or symptoms when suvorexant was discontinued. Conclusions Suvorexant improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.

Original languageEnglish (US)
Pages (from-to)136-148
Number of pages13
JournalBiological Psychiatry
Volume79
Issue number2
DOIs
StatePublished - Jan 15 2016
Externally publishedYes

Keywords

  • Insomnia
  • Orexin
  • Pharmacotherapy
  • Randomized controlled trial
  • Sleep
  • Suvorexant

ASJC Scopus subject areas

  • Biological Psychiatry

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  • Cite this

    Herring, W. J., Connor, K. M., Ivgy-May, N., Snyder, E., Liu, K., Snavely, D. B., Krystal, A. D., Walsh, J. K., Benca, R. M., Rosenberg, R., Sangal, R. B., Budd, K., Hutzelmann, J., Leibensperger, H., Froman, S., Lines, C., Roth, T., & Michelson, D. (2016). Suvorexant in Patients with Insomnia: Results from Two 3-Month Randomized Controlled Clinical Trials. Biological Psychiatry, 79(2), 136-148. https://doi.org/10.1016/j.biopsych.2014.10.003