Suvorexant for primary insomnia: A systematic review and meta-analysis of randomized placebo-controlled trials

Taro Kishi, Shinji Matsunaga, Nakao Iwata

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Objective: We performed a systematic review and meta-analysis of double-blind, randomized, placebocontrolled trials evaluating suvorexant for primary insomnia. Methods: Relevant studies were identified through searches of PubMed, databases of the Cochrane Library, and PsycINFO citations through June 27, 2015. We performed a systematic review and meta-analysis of suvorexant trial efficacy and safety outcomes. The primary efficacy outcomes were either subjective total sleep time (sTST) or subjective time-to-sleep onset (sTSO) at 1 month. The secondary outcomes were other efficacy outcomes, discontinuation rate, and individual adverse events. The risk ratio, number-needed-to-treat/harm, and weighted mean difference (WMD) and 95% confidence intervals (CI) based on a random effects model were calculated. Results: The computerized literature database search initially yielded 48 results, from which 37 articles were excluded following a review of titles and abstracts and another eight review articles after full-text review. Thus, we identified 4 trials that included a total of 3,076 patients. Suvorexant was superior to placebo with regard to the two primary efficacy outcomes (sTST: WMD = -20.16, 95% CI = -25.01 to -15.30, 1889 patients, 3 trials, sTSO: WMD = -7.62, 95% CI = -11.03 to -4.21, 1889 patients, 3 trials) and was not different from placebo in trial discontinuations. Suvorexant caused a higher incidence than placebo of at least one side effects, abnormal dreams, somnolence, excessive daytime sleepiness/sedation, fatigue, dry mouth, and rebound insomnia. Conclusions: Our analysis of published trial results suggests that suvorexant is effective in treating primary insomnia and is well-tolerated.

Original languageEnglish
Article numbere0136910
JournalPloS one
Volume10
Issue number8
DOIs
Publication statusPublished - 28-08-2015

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systematic review
Sleep Initiation and Maintenance Disorders
sleep
meta-analysis
placebos
Meta-Analysis
Randomized Controlled Trials
Placebos
Sleep
confidence interval
Confidence Intervals
Databases
sedation
relative risk
Numbers Needed To Treat
mouth
PubMed
adverse effects
Libraries
Fatigue

All Science Journal Classification (ASJC) codes

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

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title = "Suvorexant for primary insomnia: A systematic review and meta-analysis of randomized placebo-controlled trials",
abstract = "Objective: We performed a systematic review and meta-analysis of double-blind, randomized, placebocontrolled trials evaluating suvorexant for primary insomnia. Methods: Relevant studies were identified through searches of PubMed, databases of the Cochrane Library, and PsycINFO citations through June 27, 2015. We performed a systematic review and meta-analysis of suvorexant trial efficacy and safety outcomes. The primary efficacy outcomes were either subjective total sleep time (sTST) or subjective time-to-sleep onset (sTSO) at 1 month. The secondary outcomes were other efficacy outcomes, discontinuation rate, and individual adverse events. The risk ratio, number-needed-to-treat/harm, and weighted mean difference (WMD) and 95{\%} confidence intervals (CI) based on a random effects model were calculated. Results: The computerized literature database search initially yielded 48 results, from which 37 articles were excluded following a review of titles and abstracts and another eight review articles after full-text review. Thus, we identified 4 trials that included a total of 3,076 patients. Suvorexant was superior to placebo with regard to the two primary efficacy outcomes (sTST: WMD = -20.16, 95{\%} CI = -25.01 to -15.30, 1889 patients, 3 trials, sTSO: WMD = -7.62, 95{\%} CI = -11.03 to -4.21, 1889 patients, 3 trials) and was not different from placebo in trial discontinuations. Suvorexant caused a higher incidence than placebo of at least one side effects, abnormal dreams, somnolence, excessive daytime sleepiness/sedation, fatigue, dry mouth, and rebound insomnia. Conclusions: Our analysis of published trial results suggests that suvorexant is effective in treating primary insomnia and is well-tolerated.",
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Suvorexant for primary insomnia : A systematic review and meta-analysis of randomized placebo-controlled trials. / Kishi, Taro; Matsunaga, Shinji; Iwata, Nakao.

In: PloS one, Vol. 10, No. 8, e0136910, 28.08.2015.

Research output: Contribution to journalArticle

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