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

  • Kishi T
  • Matsunaga S
  • Iwata N
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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.

Author-supplied keywords

  • abnormal dreaming/si [Side Effect]
  • age distribution
  • article
  • clinical effectiveness
  • daytime somnolence/si [Side Effect]
  • drug safety
  • drug tolerability
  • fatigue/si [Side Effect]
  • human
  • insomnia/dt [Drug Therapy]
  • insomnia/si [Side Effect]
  • intention to treat analysis
  • meta analysis
  • outcome assessment
  • placebo
  • randomized controlled trial (topic)
  • rebound insomnia/si [Side Effect]
  • risk assessment
  • sedation
  • sex difference
  • side effect/si [Side Effect]
  • sleep quality
  • sleep time
  • somnolence/si [Side Effect]
  • suvorexant/ae [Adverse Drug Reaction]
  • suvorexant/ct [Clinical Trial]
  • suvorexant/dt [Drug Therapy]
  • systematic review
  • treatment duration
  • treatment outcome
  • xerostomia/si [Side Effect]

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  • T Kishi

  • S Matsunaga

  • N Iwata

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