drugset / Trial / NCT03008447
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
RandomizedCrossoverTriple-blindOther
Summary
E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.
Timeline
- Start
- 2016-11-21
- Primary completion
- 2018-01-03
- Completion
- 2018-01-03
Outcome
Met primary endpoint
release “Study 108 met its primary endpoint resulting in a statistically significant difference in postural stability” eisai.com ↗
Publications
- Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs Aging. 2024 Sep;41(9):741-752. doi: 10.1007/s40266-024-01135-8. Epub 2024 Aug 9.
- Murphy P, Kumar D, Zammit G, Rosenberg R, Moline M. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. J Clin Sleep Med. 2020 May 15;16(5):765-773. doi: 10.5664/jcsm.8294. Epub 2020 Feb 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemborexant | Small molecule | 5 mg | — |
| Subject | Lemborexant | Small molecule | 10 mg | — |
| Subject | Zolpidem | Small molecule | 6.25 mg | — |
Indications
No indication recorded.