A Study of Lemborexant in Chinese Participants With Insomnia Disorder

  • participants needed
  • sponsor
    Eisai Co., Ltd.
Updated on 5 December 2022
wake after sleep onset
middle insomnia


The primary purpose of this study is to confirm using polysomnography (PSG) that lemborexant 10 milligram (mg) is superior to placebo on objective sleep onset as assessed by latency to persistent sleep (LPS) during the last 2 nights of 1 month of treatment in participants with insomnia disorder.


The study will have 2 phases: the Prerandomization Phase and the Randomization Phase. The Prerandomization Phase will comprise 3 periods that will last up to a maximum of 35 days: a Screening Period, a Run-in Period, and a Baseline Period. The Randomization Phase will comprise a Treatment Period during which participants will be treated for 30 nights (1 month) and a minimum 14-day Follow-up Period before an End of Study (EOS) Visit (up to 54 days). The total study duration for each participant on this study is 89 days.

Condition Sleep Initiation and Maintenance Disorders
Treatment Placebo, Lemborexant
Clinical Study IdentifierNCT04549168
SponsorEisai Co., Ltd.
Last Modified on5 December 2022

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