Lemborexant Shift Work Treatment Study
Completed · Phase 4 · Has a placebo group
Conditions studied: Shift-Work Related Sleep Disturbance
In brief
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.
Key facts
- Study ID
- NCT05344443
- Run by
- University of California, San Francisco
- People needed
- 29
- Starts
- 2022-03-10
- Expected to finish
- 2024-11-30
- Last updated by the study team
- 2026-02-04
Who can join
Age: 20 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Full-time night shift work (at least 6 hours per shift, 4 days per week or 32 hours per week)
- Employed as a night shift worker for at least 3 months
- Self-reported concerns about daytime sleepiness and difficulty sleeping during the daytime
You may not qualify if…
- Pregnancy (verified by urine pregnancy test) or plan to become pregnant in the next 3 months
- Currently breastfeeding
- Inadequate opportunity for sleep during the daytime (< 7 hours opportunity) after overnight shift
- Extreme circadian preference (based on Horne \& Ostberg Morningness-Eveningness Questionnaire)
- Severe depressive symptoms (>25 on CES-D)
- Unwillingness to discontinue sleep aids (prescription or non-prescription) during the study period
- Presence of sleep disordered breathing (verified by Apnea link)
- Self-reported diagnosis of narcolepsy, restless legs syndrome
- Self-reported intake of >600mg of caffeine per night shift or use of stimulants during night shift, rotational, or irregular shifts
- Unstable or untreated medical or psychiatric condition based on clinical interview.
- Severe hepatic or renal impairment (based on chemistry panel);
- Self-reported use of digoxin or strong or moderate cytochrome P450 3A4 isozyme inhibitors or cytochrome P450 3A4 isozyme inducers for 6 months prior to or during the study
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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