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A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)

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Trial Profile

A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2023

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At a glance

  • Drugs Lemborexant (Primary)
  • Indications Insomnia
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 303; SUNRISE 2
  • Sponsors Eisai Co Ltd; 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
    • 01 Aug 2023 Results assessing The efficacy and safety of lemborexant (LEM), a competitive dual orexin receptor antagonist, was assessed for 12 months in a subgroup of midlife women (age, 40-58 y) from this study published in the Menopause
    • 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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