CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
Lemborexant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05344443
NCT05344443Phase 4Completed
CompareCT.gov

Effect of a Dual Orexin Receptor Antagonist, Lemborexant, on Total Sleep Time in Shift Workers: a Randomized Controlled Trial

University of California, San Francisco·interventional·Posted Apr 25, 2022·Updated Feb 4, 2026

In Brief

A Phase 4 clinical trial evaluating Lemborexant and Placebo for Shift-Work Related Sleep Disturbance. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShift-Work Related Sleep Disturbance
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedApr 25, 2022
Enrollment StartMar 10, 2022
Primary CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.2 years ago

Interventions

Lemborexantdrug

A dual orexin antagonist

Placebodrug

A placebo that looks and tastes like Lemborexant tablets