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Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials.

Publication ,  Journal Article
Herring, WJ; Connor, KM; Snyder, E; Snavely, DB; Zhang, Y; Hutzelmann, J; Matzura-Wolfe, D; Benca, RM; Krystal, AD; Walsh, JK; Lines, C ...
Published in: J Clin Sleep Med
September 15, 2016

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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629.

Duke Scholars

Published In

J Clin Sleep Med

DOI

EISSN

1550-9397

Publication Date

September 15, 2016

Volume

12

Issue

9

Start / End Page

1215 / 1225

Location

United States

Related Subject Headings

  • Young Adult
  • Triazoles
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Sleep Aids, Pharmaceutical
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Herring, W. J., Connor, K. M., Snyder, E., Snavely, D. B., Zhang, Y., Hutzelmann, J., … Michelson, D. (2016). Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials. J Clin Sleep Med, 12(9), 1215–1225. https://doi.org/10.5664/jcsm.6116
Herring, W Joseph, Kathleen M. Connor, Ellen Snyder, Duane B. Snavely, Ying Zhang, Jill Hutzelmann, Deborah Matzura-Wolfe, et al. “Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials.J Clin Sleep Med 12, no. 9 (September 15, 2016): 1215–25. https://doi.org/10.5664/jcsm.6116.
Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, et al. Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials. J Clin Sleep Med. 2016 Sep 15;12(9):1215–25.
Herring, W. Joseph, et al. “Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials.J Clin Sleep Med, vol. 12, no. 9, Sept. 2016, pp. 1215–25. Pubmed, doi:10.5664/jcsm.6116.
Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials. J Clin Sleep Med. 2016 Sep 15;12(9):1215–1225.

Published In

J Clin Sleep Med

DOI

EISSN

1550-9397

Publication Date

September 15, 2016

Volume

12

Issue

9

Start / End Page

1215 / 1225

Location

United States

Related Subject Headings

  • Young Adult
  • Triazoles
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Sleep Aids, Pharmaceutical
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Humans
  • Female