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Can a sleep pill help smokers kick the habit?

NCT ID NCT07328594

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether daridorexant, a recently FDA-approved sleep medication, can improve sleep quality and daytime alertness in smokers who struggle with insomnia during quit attempts. About 44 adult smokers who smoke at least 10 cigarettes daily will take the drug or a placebo for 3 weeks while trying to reduce or stop smoking. Researchers will monitor sleep patterns, alertness, and withdrawal symptoms to see if better sleep helps with quitting.

What this could mean

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

Active substance
daridorexant
What this could lead to
If successful, daridorexant could help smokers with insomnia sleep better and stay alert during quit attempts, potentially improving cessation rates.
What could go wrong
This is a small, early-phase trial with only 44 participants, so results may not apply widely. The drug may not improve smoking abstinence or could cause side effects like daytime drowsiness.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 1. Adult participants who are cigarette smokers, 18-55 years of age. 2. Smokers: greater than 10 cigarettes/day. 3. Smoking for 1 year or longer. 4. Willingness to try to reduce or stay abstinent from cigarettes, smoking cessation aides (including nicotine gum or patches), smokeless tobacco, or electronic cigarettes for 3 weeks during the study. 5. Willingness to monitor sleep at home with an external device and maintain a simple sleep and smoking diary for 3 weeks. 6. Willingness to take a 5-min, mobile-based test 3X/day for 3 days/week during the 3 weeks. 7. Ability to travel to three Study Visits. 8. Are willing to abstain from consuming grapefruit products during the study. 9. Have an iPhone, best with iOS 17 or newer. EXCLUSION: 1. Are currently taking any pharmaceutical drugs for smoking cessation, including: Nicotine patch or nicotine gum, buproprion (Wellbutrin, Zyban), varenicline (Chantix, Champix), other behavioral interventions such as cognitive behavioral therapy for smoking. 2. Are currently using cannabis or alcohol for sleep. Are currently taking any pharmaceutical drugs for insomnia, such as eszopiclone (Lunesta), zaleplon (Sonata) or zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) benzodiazepines, or opioids. 3. Are currently taking stimulants commonly used for ADHD, such as methylphenidate (Ritalin Concerta, Daytrana) or amphetamines (Adderall, Dexedrine, Vyvanse). 4. Are currently taking anti-seizure drugs, including lamotrigine, pregabalin (Lyrica), or gabapentin (Neurontin, Horizant, or Gralise). 5. Have non-nicotine substance dependence (diagnosed with substance use disorder, including alcohol or cannabis use disorder (current cannabis use is acceptable, and past illicit drug use is acceptable if greater than 2 months prior to testing and does not meet current criteria for substance use disorders (SUDs) according to DSM-5). 6. Have a major neurological disorder such as Parkinson's disease, epilepsy, Alzheimer's disease, multiple sclerosis, or any other serious neurological disorder. 7. Have a history of serious psychiatric disorders including bipolar disorder, schizophrenia, or suicidality. 8. Had a stroke or head injury which caused loss of consciousness for longer than three minutes in the past 1 year. 9. Are pregnant or breastfeeding. 10. Have been diagnosed with sleep apnea or other diagnosed sleep disorders such as narcolepsy. 11. Have been diagnosed with thyroid problems. 12. Have been diagnosed with COPD. 13. Have been doing variable shift work in the past 1 month or traveled more than 1 time zone in past month. 14. Are currently taking the following medications, supplements, or food: Daridorexant can interact with strong inhibitors of CYP3A4, which should be discussed with The Study Doctor's office (some of these include clarithromycin, diltiazem, erythromycin, itraconzale, ketoconazole, ritonavir, and verapamil). 15. Have a BMI of 33 or higher.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Legacy Research Institute

    Portland, Oregon, 97232, United States

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