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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: 23 Jul 2026

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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 Jul 2026 According to an Eisai Inc media release, company announced that the European Medicines Agency (EMA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist lemborexant (generic name) for the treatment of adult patients with chronic insomnia.
  • 02 Jul 2026 According to an Eisai Inc media release, company announced today that the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for evaluation a marketing authorization application (MAA) for lemborexant for the treatment of adult patients with insomnia.
  • 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

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