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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: 10 Oct 2023

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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

    • 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.
    • 27 Apr 2023 Results of post hoc analysis(n=410) assessing effects of lemborexant (LEM), a competitive dual orexin receptor antagonist approved in multiple countries for the treatment of insomnia disorder, in patients with comorbid insomnia and obstructive sleep apnea of mild severity presented at the 75th Annual Meeting of the American Academy of Neurology 2023
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