Phase 4 N=29 Randomized Quadruple-blind Treatment

Lemborexant Shift Work Treatment Study

Shift-Work Related Sleep Disturbance

Bottom Line

View on ClinicalTrials.gov: NCT05344443 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcome: Primary: Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary — 362.7; 365.3 Minutes per day — p=0.884

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lemborexant (Drug); Placebo (Drug)
Age: Adult · 20+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary	362.7; 365.3	0.884
SECONDARY Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy	318.4; 324.0	0.494

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.

Eligibility 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 ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05344443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.