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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
Employed as a night shift worker for at least 3 months
Self-reported concerns about daytime sleepiness and difficulty sleeping during the daytime
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have worked night shifts for at least 3 months.
Select...
You have reported problems with feeling sleepy during the day and difficulty sleeping during the day.
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You work night shifts for at least 6 hours per shift, 4 days per week or 32 hours per week.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Daytime Total Sleep Time in Minutes Collected from the Consensus Sleep Diary
Secondary outcome measures
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
Placebo
Zolpidem Tartrate Extended Release 6.25 mg
Lemborexant 5 mg
Lemborexant 10 mg
Run -in Period Placebo

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
~1900

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,753 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: Active Treatment, Placebo 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this trial available?

"This medical trial has space for 45 individuals aged between 20 and 60, who have dyssomnias. Furthermore, the participants must be employed in a night shift role for at least 3 months prior to enrolment; that is 6 hours per shift across 4 days every week or 32 hours weekly, with self-declared issues about daytime sleepiness or difficulty sleeping during daylight hours."

Answered by AI

Is this medical trial open to individuals above the age of forty?

"Within the eligible age bracket of 20 to 60 years, this study is open for recruitment."

Answered by AI

Are investigators still onboarding participants for this research experiment?

"Surveying the clinicaltrials.gov website, one can deduce that this research project is actively recruiting subjects. The trial was established on March 10th 2022 and modified for its most recent iteration on April 19th of the same year."

Answered by AI

Has the Food and Drug Administration authorized Lemborexant for use?

"There has been ample data collected to ensure the safety of Lemborexant, leading it to gain a score of 3."

Answered by AI

How many participants is the research team enrolling in this trial?

"Indeed, evidence on clinicaltrials.gov indicates that this trial is actively looking for recruits. Originally posted on March 10th 2022, it has recently been updated April 19th of the same year and requires 45 individuals from one medical site to participate."

Answered by AI
~15 spots leftby Mar 2025