Suvorexant in patients with insomnia: Pooled analyses of three-month data from phase-3 randomized controlled clinical trials

W. Joseph Herring, Kathleen M. Connor, Ellen Snyder, Duane B. Snavely, Ying Zhang, Jill Hutzelmann, Deborah Matzura-Wolfe, Ruth M. Benca, Andrew D. Krystal, James K. Walsh, Christopher Lines, Thomas Roth, David Michelson

Research output: Contribution to journalArticle

Abstract

Study Objectives: Suvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials. Methods: Prespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18-64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints. Results: Suvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use. Conclusions: Suvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.

Original languageEnglish (US)
Pages (from-to)1215-1225
Number of pages11
JournalJournal of Clinical Sleep Medicine
Volume12
Issue number9
DOIs
StatePublished - 2016
Externally publishedYes

Keywords

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

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Neurology
  • Clinical Neurology

Fingerprint Dive into the research topics of 'Suvorexant in patients with insomnia: Pooled analyses of three-month data from phase-3 randomized controlled clinical trials'. Together they form a unique fingerprint.

  • Cite this

    Herring, W. J., Connor, K. M., Snyder, E., Snavely, D. B., Zhang, Y., Hutzelmann, J., Matzura-Wolfe, D., Benca, R. M., Krystal, A. D., Walsh, J. K., Lines, C., Roth, T., & Michelson, D. (2016). Suvorexant in patients with insomnia: Pooled analyses of three-month data from phase-3 randomized controlled clinical trials. Journal of Clinical Sleep Medicine, 12(9), 1215-1225. https://doi.org/10.5664/jcsm.6116