drugset / Trial / NCT02583451
Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
RandomizedCrossoverDouble-blindBasic science
Summary
This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance
Timeline
- Start
- 2015-11
- Primary completion
- 2017-01-31
- Completion
- 2017-02
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.
- Vermeeren A, Jongen S, Murphy P, Moline M, Filippov G, Pinner K, Perdomo C, Landry I, Majid O, Van Oers ACM, Van Leeuwen CJ, Ramaekers JG, Vuurman EFPM. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019 Apr 1;42(4):zsy260. doi: 10.1093/sleep/zsy260.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemborexant | Small molecule | 2.5 mg | Oral |
| Subject | Lemborexant | Small molecule | 5 mg | Oral |
| Subject | Lemborexant | Small molecule | 10 mg | Oral |
| Subject | Zopiclone | Small molecule | 7.5 mg | Oral |
Indications
No indication recorded.