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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: 23 Jul 2026

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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

  • 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.
  • 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

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