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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2024

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At a glance

  • Drugs Lemborexant (Primary) ; Zolpidem
  • Indications Insomnia; Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 304; SUNRISE 1
  • Sponsors Eisai Inc

    • Most Recent Events

    • 18 Apr 2024 Results (n=525) assessing response and remission rates of lemborexant (LEM) in older adults with insomnia disorder and objective short sleep presented at the 76th Annual Meeting of the American Academy of Neurology 2024
    • 02 Oct 2023 Results from NCT02783729, NCT02952820, NCT03545191, NCT03575104; determining if there are differences in the number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH) between lemborexant and daridorexant and indirectly comparing lemborexant with daridorexant , published in the Journal of Clinical Psychiatry
    • 02 Jun 2023 According to a Eisai Co Ltd media release, data from this study will be presented at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3-7, 2023 in Indianapolis, IN, the United States.

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