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A Randomized, Double-Blind, Placebo-Controlled and Active Comparator, 4 Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled and Active Comparator, 4 Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Feb 2021

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At a glance

  • Drugs Lemborexant (Primary) ; Zolpidem
  • Indications Circadian rhythm sleep disorders; Insomnia; Sleep apnoea syndrome
  • Focus Therapeutic Use
  • Sponsors Eisai Inc

    • Most Recent Events

    • 01 Jan 2021 Results assessing potential of lemborexant for residual morning and next-day effects, including somnolence from 9 studies (E2006-A001-001 Part B, E2006-A001-002, E2006-A001-003, E2006-E044-106, E2006-A001-107, E2006-A001-108, E2006-G000-201, E2006-G000-303 & E2006-G000-304) published in the Postgraduate Medicine.
    • 23 Jan 2020 According to an Eisai Inc media release, the company has obtained the manufacturing and marketing approval in Japan for its in-house discovered orexin receptor antagonist DAYVIGO (2.5mg, 5mg, and 10mg tablets, lemborexant) for treatment of insomnia. This approval was based on SUNRISE 1 ,SUNRISE 2, Study 108 and Study 106.
    • 23 Dec 2019 According to an Eisai Inc media release, U.S. Food and Drug Administration (FDA) approved DAYVIGO™ (lemborexant) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The approval was based on a robust clinical development program that include SUNRISE 1, SUNRISE 2, study 106 and study 108
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