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Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data.

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: Psychopharmacology (Berl)
June 2017

RATIONALE: Sex-related differences in the clinical profiles of some insomnia medications have been previously reported. OBJECTIVE: To evaluate the clinical profile of suvorexant, a novel orexin receptor antagonist approved for treating insomnia at doses up to 20 mg, by sex subgroups. METHODS: Efficacy analyses by sex were based on pooled data from two similar phase 3, randomized, double-blind, placebo-controlled, 3-month trials in elderly (≥65 years) and non-elderly (18-64 years) insomnia patients. Two age-adjusted (non-elderly/elderly) dose regimes of 40/30 and 20/15 mg were evaluated, with fewer patients assigned to 20/15 mg. Efficacy was assessed by patient-reported outcomes (N = 1264 women, 707 men) and by polysomnography endpoints in ~75% of patients. Safety analyses by sex (N = 1744 women, 1065 men) included pooled data from the two 3-month trials plus 3-month data from a safety trial of 40/30 mg. RESULTS: The sex subgroup efficacy analyses mirrored the improvements seen for suvorexant 40/30 and 20/15 mg over placebo on patient-reported outcomes and polysomnography sleep maintenance and onset endpoints in the primary analyses; 95% CIs excluded zero in favor of suvorexant for most endpoints in both sexes, and similar efficacy was observed between sexes (95% CIs overlapped). Suvorexant was well-tolerated in women and men, although women in all treatment groups (including placebo) reported more adverse events than men. The most frequent adverse event was somnolence (women: 11.1% for 40/30 mg, 8.5% for 20/15 mg, 2.3% for placebo; men: 10.1% for 40/30 mg, 3.4% for 20/15 mg, 4.2% for placebo). CONCLUSION: Suvorexant was generally effective and well-tolerated in both women and men with insomnia. ClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629, NCT01021813.

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Published In

Psychopharmacology (Berl)

DOI

EISSN

1432-2072

Publication Date

June 2017

Volume

234

Issue

11

Start / End Page

1703 / 1711

Location

Germany

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Time Factors
  • Statistics as Topic
  • Sleep Initiation and Maintenance Disorders
  • Sleep Aids, Pharmaceutical
  • Sleep
  • Psychiatry
  • Polysomnography
  • Middle Aged
 

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Herring, W. J., Connor, K. M., Snyder, E., Snavely, D. B., Zhang, Y., Hutzelmann, J., … Michelson, D. (2017). Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data. Psychopharmacology (Berl), 234(11), 1703–1711. https://doi.org/10.1007/s00213-017-4573-1
Journal cover image

Published In

Psychopharmacology (Berl)

DOI

EISSN

1432-2072

Publication Date

June 2017

Volume

234

Issue

11

Start / End Page

1703 / 1711

Location

Germany

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Time Factors
  • Statistics as Topic
  • Sleep Initiation and Maintenance Disorders
  • Sleep Aids, Pharmaceutical
  • Sleep
  • Psychiatry
  • Polysomnography
  • Middle Aged