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Can a pill help Night-Shift workers sleep during the day?

NCT ID NCT06231641

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether lemborexant, a sleep medication, can help people who work night shifts get better daytime sleep without feeling drowsy later. Five healthy adults who had not done shift work in the past year took either lemborexant or a placebo before daytime sleep in a lab. The goal was to see if the drug improves total sleep time and reduces wakefulness after falling asleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lemborexant (Dayvigo)
What this could lead to
If it works, this could point toward a treatment for shift work disorder, helping people sleep better after night shifts.
What could go wrong
This is a very small, early feasibility study with only 5 participants, and it was terminated. Results may not apply to everyone, and lemborexant may cause next-day drowsiness or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Jan 2024

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must fulfill all of the following inclusion criteria to be eligible for inclusion in this study: 1. Men or women aged between 20 and 65 years, inclusive 2. Be willing and able to give informed consent for study participation 3. Participants must not have done shiftwork in the past year 4. Normal vital signs values are: oral body temperature between 36.1 and 37.5 ºC (95 and 99.5 °F), supine SBP between 90 and 140 mmHg inclusive; supine DBP between 55 and 90 mmHg inclusive; heart rate between 50 and 100 bpm inclusive. 5. Be willing to comply with all study requirements and procedures for the duration of the study, including refraining from consuming alcohol 48 hours prior to each experimental visit and grapefruit products (juice or fruit itself), Seville orange, lime, pomelo, carambola and pomegranate during all the duration of the study (from Visit 1 to Visit 4). 6. Women who: * Are postmenopausal, with amenorrhea for at least 1 year before the screening visit, OR * Are surgically sterile, OR * If of childbearing potential agree to practice effective double barrier methods of contraception, from the time of the signing of informed consent through the last dose of study drug and for 30 days after dosing stops (1 ovulatory cycle), or agree to completely abstain from intercourse. Men with women partners of childbearing potential are also expected to practice effective barrier methods of contraception from the time of signing informed consent through the last dose of study drug and for 30 days after dosing stops. 7. Self-reported bedtime was between 9 pm and midnight on 4-7 nights per week. Exclusion Criteria: Participants must not meet any of the following exclusion criteria: 1. Body mass index \> 32 as calculated from the participant's height (m) and weight (kg); weight (kg)/square height (m²) 2. Presence of a sleep disorder, such as a diagnosis of insomnia, narcolepsy, sleep paralysis, active somnambulism (history of childhood somnambulism is accepted), hypnagogic/ hypnopompic hallucinations, and REM behavior disorder, will be excluded based on the clinical interview. For sleep apnea syndrome, an apnea-hypopnea index \> 15 per hour of sleep on the first screening night will be used as an exclusion criterion. For periodic limb movement disorder, an index of periodic limb movements during sleep associated with an arousal \> 15 per hour of sleep on the first screening night will be used as an exclusion criterion. 3. History of epilepsy 4. Any previous serious head injury or stroke 5. Any evidence of psychiatric disorder (including Beck Depression Inventory \[BDI\] ≥ 20 at screening, or a score of 3 on item related to suicidal ideas) 6. Evidence of any clinically significant, or unstable, acute or chronically progressive medical or surgical disorder (including planned medical procedures that may impact sleep), or any condition that may interfere with the absorption, metabolism, distribution, or excretion of the study drug, or may affect the participant's safety 7. Clinically significant and abnormal electrocardiogram (ECG; including QTc ≥ 450 ms for males, 460 ms for females) or a history of cardiovascular disease including poorly controlled hypertension, ischemic heart disease, arrhythmia, or severe heart failure 8. Severe hepatic impairment 9. Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene) and alcohol test (breathalyzer), at screening and before each experimental visit 10. Current use of medications that are moderate or strong CYP3A4 inhibitors or inducers or CYP2B6 substrates (Appendix 1) 11. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including hypnotics, neuroleptics, opioid derivatives, antihistamines, stimulants, antidepressants, within one week or five half-lives (whichever is longer) prior to PSG screening 12. Use of any over-the-counter sleep medications including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St John's Wort (Hypericum perforatum), Alluna (herbal sleep supplement with valerian root), and hemp within one week or five half-lives (whichever is longer) prior to screening 13. Consumption of xanthine-containing beverages (i.e., tea, coffee, or cola) of more than 5 cups or glasses per day 14. Participation in any other trial within 30 days before the screening visit 15. Any travel across more than one time zone in the month prior to screening at any time during the study 16. Other exclusion criteria based on adverse events (AE) or serious adverse events (SAE) reported in the Investigator Brochure 17. Women who are pregnant, during the study or within one month after the study, or are breastfeeding 18. Individuals may be excluded from participating in the study based on the clinician's judgement. 19. Participants with lactose or galactose intolerance (galactosemia or glucose-galactose malabsorption)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CIUSSS du Nord de l'ile de Montreal (CIUSSS-NIM) - Hôpital du Sacré-Cœur de Montréal (HSCM)

    Montreal, Quebec, H4J 1C5, Canada

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Other studies related to the condition(s) this trial covers.