Lemborexant for Dyssomnias

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of California, San Francisco, San Francisco, CA
Dyssomnias+2 More
Lemborexant - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Dyssomnias
  • Shift-Work Related Sleep Disturbance

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline and 2 Weeks

Baseline and 2 Weeks
Changes in Daytime Total Sleep Time in Minutes Collected from the Consensus Sleep Diary
Changes in Daytime Total Sleep Time in Minutes Measured by Actigraphy

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Zolpidem Tartrate Extended Release 6.25 mg
5%Headache
2%Somnolence
0%Coronary artery disease
0%Peripheral vascular disorder
0%Pneumonia
0%Abdominal hernia
0%Small intestinal obstruction
0%Chest pain
0%Gastroenteritis viral
0%Back pain
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT02783729) in the Zolpidem Tartrate Extended Release 6.25 mg ARM group. Side effects include: Headache with 5%, Somnolence with 2%, Coronary artery disease with 0%, Peripheral vascular disorder with 0%, Pneumonia with 0%.

Trial Design

2 Treatment Groups

Active Treatment
1 of 2
Placebo Treatment
1 of 2
Experimental Treatment
Non-Treatment Group

45 Total Participants · 2 Treatment Groups

Primary Treatment: Lemborexant · Has Placebo Group · Phase 4

Active Treatment
Drug
Experimental Group · 1 Intervention: Lemborexant · Intervention Types: Drug
Placebo Treatment
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lemborexant
2018
Completed Phase 3
~1660

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 2 weeks
Closest Location: University of California, San Francisco · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
2008First Recorded Clinical Trial
1 TrialsResearching Dyssomnias
689 CompletedClinical Trials

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,246 Previous Clinical Trials
11,473,629 Total Patients Enrolled
4 Trials studying Dyssomnias
1,783 Patients Enrolled for Dyssomnias
Aric Prather, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
164 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are employed as a night shift worker for at least 3 months.
You are a full-time night shift worker.\n
You report concerns about daytime sleepiness and difficulty sleeping during the daytime.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.