Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men

subgroup analysis of pooled phase-3 data

W. J. Herring, Kathryn 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

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.

Original languageEnglish (US)
Pages (from-to)1-9
Number of pages9
JournalPsychopharmacology
DOIs
StateAccepted/In press - Mar 7 2017

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Sleep Initiation and Maintenance Disorders
Placebos
Polysomnography
Therapeutics
Safety
Sex Characteristics
suvorexant
Sleep
Maintenance

Keywords

  • Gender differences
  • Insomnia
  • Men
  • Orexin
  • Sex differences
  • Suvorexant
  • Women

ASJC Scopus subject areas

  • Pharmacology

Cite this

Herring, W. J., Connor, K. M., Snyder, E., Snavely, D. B., Zhang, Y., Hutzelmann, J., ... Michelson, D. (Accepted/In press). Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data. Psychopharmacology, 1-9. https://doi.org/10.1007/s00213-017-4573-1

Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men : subgroup analysis of pooled phase-3 data. / Herring, W. J.; Connor, Kathryn M.; Snyder, Ellen; Snavely, Duane B.; Zhang, Ying; Hutzelmann, Jill; Matzura-Wolfe, Deborah; Benca, Ruth M.; Krystal, Andrew D.; Walsh, James K.; Lines, Christopher; Roth, Thomas; Michelson, David.

In: Psychopharmacology, 07.03.2017, p. 1-9.

Research output: Contribution to journalArticle

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 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, pp. 1-9. https://doi.org/10.1007/s00213-017-4573-1
Herring, W. J. ; Connor, Kathryn M. ; Snyder, Ellen ; Snavely, Duane B. ; Zhang, Ying ; Hutzelmann, Jill ; Matzura-Wolfe, Deborah ; Benca, Ruth M. ; Krystal, Andrew D. ; Walsh, James K. ; Lines, Christopher ; Roth, Thomas ; Michelson, David. / Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men : subgroup analysis of pooled phase-3 data. In: Psychopharmacology. 2017 ; pp. 1-9.
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AU - Benca, Ruth M.

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