Lemborexant Shift Work Treatment Study

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Lemborexant Shift Work Treatment Study

Condition
Shift-Work Related Sleep Disturbance
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

20 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Aric Prather, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-06-30