Suvorexant in patients with insomnia: Pooled analyses of three-month data from phase-3 randomized controlled clinical trials

W. Joseph Herring, Kathleen 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

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.

Original languageEnglish (US)
Pages (from-to)1215-1225
Number of pages11
JournalJournal of Clinical Sleep Medicine
Volume12
Issue number9
DOIs
StatePublished - 2016
Externally publishedYes

Fingerprint

Phase III Clinical Trials
Sleep Initiation and Maintenance Disorders
Randomized Controlled Trials
Placebos
Sleep
Maintenance
Polysomnography
suvorexant
Signs and Symptoms

Keywords

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

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Neurology
  • Clinical Neurology

Cite this

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. Journal of Clinical Sleep Medicine, 12(9), 1215-1225. https://doi.org/10.5664/jcsm.6116

Suvorexant in patients with insomnia : Pooled analyses of three-month data from phase-3 randomized controlled clinical trials. / Herring, W. Joseph; Connor, Kathleen 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: Journal of Clinical Sleep Medicine, Vol. 12, No. 9, 2016, p. 1215-1225.

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 2016, 'Suvorexant in patients with insomnia: Pooled analyses of three-month data from phase-3 randomized controlled clinical trials', Journal of Clinical Sleep Medicine, vol. 12, no. 9, pp. 1215-1225. https://doi.org/10.5664/jcsm.6116
Herring, W. Joseph ; Connor, Kathleen 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. / Suvorexant in patients with insomnia : Pooled analyses of three-month data from phase-3 randomized controlled clinical trials. In: Journal of Clinical Sleep Medicine. 2016 ; Vol. 12, No. 9. pp. 1215-1225.
@article{4db2da50763e4a8faf4c7e43399c2868,
title = "Suvorexant in patients with insomnia: Pooled analyses of three-month data from phase-3 randomized controlled clinical trials",
abstract = "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.",
keywords = "Insomnia, Orexin, Pharmacotherapy, Randomized controlled trial, Sleep, Suvorexant",
author = "Herring, {W. Joseph} and Connor, {Kathleen M.} and Ellen Snyder and Snavely, {Duane B.} and Ying Zhang and Jill Hutzelmann and Deborah Matzura-Wolfe and Benca, {Ruth M.} and Krystal, {Andrew D.} and Walsh, {James K.} and Christopher Lines and Thomas Roth and David Michelson",
year = "2016",
doi = "10.5664/jcsm.6116",
language = "English (US)",
volume = "12",
pages = "1215--1225",
journal = "Journal of Clinical Sleep Medicine",
issn = "1550-9389",
publisher = "American Academy of Sleep Medicine",
number = "9",

}

TY - JOUR

T1 - Suvorexant in patients with insomnia

T2 - Pooled analyses of three-month data from phase-3 randomized controlled clinical trials

AU - Herring, W. Joseph

AU - Connor, Kathleen M.

AU - Snyder, Ellen

AU - Snavely, Duane B.

AU - Zhang, Ying

AU - Hutzelmann, Jill

AU - Matzura-Wolfe, Deborah

AU - Benca, Ruth M.

AU - Krystal, Andrew D.

AU - Walsh, James K.

AU - Lines, Christopher

AU - Roth, Thomas

AU - Michelson, David

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

KW - Insomnia

KW - Orexin

KW - Pharmacotherapy

KW - Randomized controlled trial

KW - Sleep

KW - Suvorexant

UR - http://www.scopus.com/inward/record.url?scp=84990848575&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84990848575&partnerID=8YFLogxK

U2 - 10.5664/jcsm.6116

DO - 10.5664/jcsm.6116

M3 - Article

C2 - 27397664

AN - SCOPUS:84990848575

VL - 12

SP - 1215

EP - 1225

JO - Journal of Clinical Sleep Medicine

JF - Journal of Clinical Sleep Medicine

SN - 1550-9389

IS - 9

ER -