drugset / Trial / NCT05344443
Lemborexant Shift Work Treatment Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Insomnia and daytime sleepiness are common complaints among night shift workers, but effective sleep treatments in shift workers are lacking. The aim of this Phase IV double-blind, placebo-controlled, randomized study is to test whether a dual orexin antagonist, Lemborexant (5mg or 10mg), which would be expected to block the clock-driven orexin-mediated wakefulness during the day, will increase daytime sleep time in shift workers who complain of difficulty sleeping during the daytime compared to placebo.
Timeline
- Start
- 2022-03-10
- Primary completion
- 2024-11-30
- Completion
- 2024-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemborexant | Small molecule | 5 mg | — |
| Subject | Lemborexant | Small molecule | 10 mg | — |