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Lemborexant Shift Work Treatment Study

NCT05344443 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-02-04

Study results available
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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

Interventions

DRUG

Lemborexant

A dual orexin antagonist

DRUG

Placebo

A placebo that looks and tastes like Lemborexant tablets

Sponsors & Collaborators

Principal Investigators

  • Aric Prather, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05344443 on ClinicalTrials.gov