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Lemborexant for Shift Work Sleep Disorder
Study Summary
This trial will test whether Lemborexant can help shift workers sleep during the day.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 1006 Patients • NCT02783729Trial Design
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Who is running the clinical trial?
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- You didn't have enough chance to sleep during the day (less than 7 hours) after working overnight.You have a very strong preference for a specific time of day, based on a questionnaire about your sleep habits.You have very strong feelings of sadness and hopelessness.You have a breathing problem during sleep, confirmed by a test called Apnea link.You have been taking specific medications for the past 6 months that could interact with the study drug.You have worked night shifts for at least 3 months.You have very serious liver or kidney problems, as shown by blood tests.You have reported problems with feeling sleepy during the day and difficulty sleeping during the day.You have been diagnosed with narcolepsy or restless legs syndrome.You drink more than 600mg of caffeine or take stimulants during night, rotating, or irregular work shifts.You work night shifts for at least 6 hours per shift, 4 days per week or 32 hours per week.
- Group 1: Active Treatment
- Group 2: Placebo Treatment
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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