Skip to main content
Journal cover image

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

Publication ,  Journal Article
Herring, WJ; Connor, KM; Ivgy-May, N; Snyder, E; Liu, K; Snavely, DB; Krystal, AD; Walsh, JK; Benca, RM; Rosenberg, R; Sangal, RB; Budd, K ...
Published in: Biol Psychiatry
January 15, 2016

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Biol Psychiatry

DOI

EISSN

1873-2402

Publication Date

January 15, 2016

Volume

79

Issue

2

Start / End Page

136 / 148

Location

United States

Related Subject Headings

  • Wakefulness
  • Triazoles
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Sleep
  • Psychiatry
  • Polysomnography
  • Orexin Receptor Antagonists
  • Middle Aged
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Herring, W. J., Connor, K. M., Ivgy-May, N., Snyder, E., Liu, K., Snavely, D. B., … Michelson, D. (2016). Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. Biol Psychiatry, 79(2), 136–148. https://doi.org/10.1016/j.biopsych.2014.10.003
Herring, W Joseph, Kathryn M. Connor, Neely Ivgy-May, Ellen Snyder, Ken Liu, Duane B. Snavely, Andrew D. Krystal, et al. “Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials.Biol Psychiatry 79, no. 2 (January 15, 2016): 136–48. https://doi.org/10.1016/j.biopsych.2014.10.003.
Herring WJ, Connor KM, Ivgy-May N, Snyder E, Liu K, Snavely DB, et al. Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. Biol Psychiatry. 2016 Jan 15;79(2):136–48.
Herring, W. Joseph, et al. “Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials.Biol Psychiatry, vol. 79, no. 2, Jan. 2016, pp. 136–48. Pubmed, doi:10.1016/j.biopsych.2014.10.003.
Herring WJ, Connor KM, Ivgy-May N, Snyder E, Liu K, Snavely DB, Krystal AD, Walsh JK, Benca RM, Rosenberg R, Sangal RB, Budd K, Hutzelmann J, Leibensperger H, Froman S, Lines C, Roth T, Michelson D. Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. Biol Psychiatry. 2016 Jan 15;79(2):136–148.
Journal cover image

Published In

Biol Psychiatry

DOI

EISSN

1873-2402

Publication Date

January 15, 2016

Volume

79

Issue

2

Start / End Page

136 / 148

Location

United States

Related Subject Headings

  • Wakefulness
  • Triazoles
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Sleep
  • Psychiatry
  • Polysomnography
  • Orexin Receptor Antagonists
  • Middle Aged
  • Male