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Biol Psychiatry. 2016 Jan 15;79(2):136-48. doi: 10.1016/j.biopsych.2014.10.003. Epub 2014 Oct 23.

Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials.

Author information

  • 1Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey. Electronic address: william_herring@merck.com.
  • 2Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey.
  • 3Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.
  • 4Sleep Medicine and Research Center, St. Luke's Hospital, St. Louis, Missouri.
  • 5University of Wisconsin, Madison, Wisconsin.
  • 6Atlanta Sleep Medicine Clinic, Atlanta, Georgia.
  • 7Sleep Disorders Institute & Attention Disorders Institute, Oakland University William Beaumont School of Medicine, Sterling Heights.
  • 8Henry Ford Hospital Sleep Center, Detroit, Michigan.

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.

KEYWORDS:

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

PMID:
25526970
DOI:
10.1016/j.biopsych.2014.10.003
[PubMed - indexed for MEDLINE]
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