Lemborexant Shift Work Treatment Study

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Lemborexant

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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