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Dual Orexin Antagonist

Lemborexant for Shift Work Sleep Disorder

Phase 4
Recruiting
Led By Aric Prather, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test whether Lemborexant can help shift workers sleep during the day.

Who is the study for?
This trial is for full-time night shift workers who've been working nights for at least 3 months and are struggling with daytime sleepiness and trouble sleeping during the day. Pregnant or breastfeeding individuals, those with severe depression, untreated medical conditions, or using certain medications can't participate.
What is being tested?
The study is testing Lemborexant, a medication intended to help night shift workers sleep better during the day by blocking wakefulness signals in the brain. Participants will randomly receive either Lemborexant or a placebo to compare effectiveness.
What are the potential side effects?
Lemborexant may cause side effects such as headaches, drowsiness during waking hours (which could be dangerous if driving), unusual dreams or nightmares, and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Daytime Total Sleep Time in Minutes Collected from the Consensus Sleep Diary
Secondary study objectives
Changes in Daytime Total Sleep Time in Minutes Measured by Actigraphy

Side effects data

From 2018 Phase 3 trial • 1006 Patients • NCT02783729
5%
Headache
2%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run -in Period Placebo
Placebo
Zolpidem Tartrate Extended Release 6.25 mg
Lemborexant 5 mg
Lemborexant 10 mg

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment1 Intervention
Participants randomized into this arm will receive Lemborexant (5-10mg).
Group II: Placebo TreatmentPlacebo Group1 Intervention
Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lemborexant
2018
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,905 Total Patients Enrolled
Aric Prather, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
163 Total Patients Enrolled

Media Library

Lemborexant (Dual Orexin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05344443 — Phase 4
Shift Work Sleep Disorder Research Study Groups: Placebo Treatment, Active Treatment
Shift Work Sleep Disorder Clinical Trial 2023: Lemborexant Highlights & Side Effects. Trial Name: NCT05344443 — Phase 4
Lemborexant (Dual Orexin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05344443 — Phase 4
~12 spots leftby Dec 2025
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