Lemborexant Shift Work Treatment Study

NCT05344443 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-32763
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shift-Work Related Sleep Disturbance

Keywords

Shift Work; Daytime Sleepiness; Lemborexant

Outcome Measures

Primary Outcomes (1)

• Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary

  Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was recorded using the Consensus Sleep Diary, which participants completed daily.

  Two weeks of Treatment

Secondary Outcomes (1)

• Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy

  Two weeks of treatment

Study Arms (2)

Active Treatment

EXPERIMENTAL

Participants randomized into this arm will receive Lemborexant (5-10mg).

Drug: Lemborexant

Placebo Treatment

PLACEBO COMPARATOR

Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.

Drug: Placebo

Interventions

Lemborexant DRUG

A dual orexin antagonist

Also known as: Dayvigo

Active Treatment

Placebo DRUG

A placebo that looks and tastes like Lemborexant tablets

Placebo Treatment

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Links

• Study Screener

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

Due to challenges in recruitment and difficulties obtaining daytime sleep diaries and wrist actigraphy data, this study is likely underpowered, and the findings should be interpreted with caution.

Results Point of Contact

• Title: Aric A. Prather, PhD
• Organization: University of California, San Francisco

aric.prather@ucsf.edu

4154767758

Study Officials

• Aric Prather, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a 4-week double blinded placebo controlled trial (2 weeks of baseline assessment followed by 2-weeks of treatment/placebo). The trial design is based on a recent successful study of the treatment of sleep problems in shift workers with a hypocretin/orexin receptor antagonist

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 25, 2022
• Study Start: March 10, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)