drugset / Trial / NCT05344443

Lemborexant Shift Work Treatment Study

NCT05344443

Phase 4 Completed 29 enrolled University of California, San Francisco
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

EvaluationDrugModalityDoseRoute
Subject Lemborexant Small molecule 5 mg
Subject Lemborexant Small molecule 10 mg