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
Latest Information Update: 13 Aug 2024
At a glance
- Drugs Lemborexant (Primary) ; Zolpidem
- Indications Circadian rhythm sleep disorders; Insomnia; Sleep apnoea syndrome
- Focus Therapeutic Use
- Sponsors Eisai Inc
- 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