SmokingPhase 4NCT07328594
Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking
A Phase 4 study testing Daridorexant 50 mg in people with Smoking and Nicotine, run by Legacy Health System at 1 site in United States.
Trial summary
Tobacco use is the leading cause of preventable death in the U.S., with 480,000 deaths per year and 7.7 million deaths globally. A major clinical symptom associated with abstinence from both licit and illicit drugs is insomnia, which is a clinically verified, major risk factor for relapse. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Daridorexant 50 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult participants who are cigarette smokers, 18-55 years of age.
- Smokers: greater than 10 cigarettes/day.
- Smoking for 1 year or longer.
- 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.
- Willingness to monitor sleep at home with an external device and maintain a simple sleep and smoking diary for 3 weeks.
- Willingness to take a 5-min, mobile-based test 3X/day for 3 days/week during the 3 weeks.
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- Ability to travel to three Study Visits.
- Are willing to abstain from consuming grapefruit products during the study.
- Have an iPhone, best with iOS 17 or newer.
Who cannot join
- 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.
- 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.
- Are currently taking stimulants commonly used for ADHD, such as methylphenidate (Ritalin Concerta, Daytrana) or amphetamines (Adderall, Dexedrine, Vyvanse).
- Are currently taking anti-seizure drugs, including lamotrigine, pregabalin (Lyrica), or gabapentin (Neurontin, Horizant, or Gralise).
- 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).
- Have a major neurological disorder such as Parkinson's disease, epilepsy, Alzheimer's disease, multiple sclerosis, or any other serious neurological disorder.
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- Have a history of serious psychiatric disorders including bipolar disorder, schizophrenia, or suicidality.
- Had a stroke or head injury which caused loss of consciousness for longer than three minutes in the past 1 year.
- Are pregnant or breastfeeding.
- Have been diagnosed with sleep apnea or other diagnosed sleep disorders such as narcolepsy.
- Have been diagnosed with thyroid problems.
- Have been diagnosed with COPD.
- Have been doing variable shift work in the past 1 month or traveled more than 1 time zone in past month.
- 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).
- Have a BMI of 33 or higher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking During Abstinence
Tobacco use is the leading cause of preventable death in the U.S., with 480,000 deaths per year and 7.7 million deaths globally. A major clinical symptom associated with abstinence from both licit and illicit drugs is insomnia, which is a clinically verified, major risk factor for relapse. Roughly half of the 40 million smokers in the U.S. attempt to quit annually, with very low rates of success. One major hurdle is poor sleep quality during abstinence. Compounding the problem is that some pharmaceuticals to help reduce smoking can increase insomnia. Poor sleep is recognized as a major impediment to maintaining abstinence from several drugs of abuse, including nicotine. Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, and 80% report regular sleep disturbances, which can be amplified during abstinence. A new orexin blocker, daridorexant, was FDA approved within the past two years for the treatment of insomnia, and while it has been tested in healthy individuals with insomnia, it has not been tested in smokers, who suffer from insomnia, particularly during the withdrawal phase when trying to quit. Daridorexant has an improved profile of beneficial effects for those with insomnia, the most notable advantage being its shorter duration of action that promotes daytime alertness, which is problematic for both active smokers and smokers during withdrawal. Poor sleep leads to daytime sleepiness, which often leads to smoking to maintain alertness.
Read the detailed description
The investigators will use a randomized, double-blind placebo-controlled design to determine how daridorexant given over 3 weeks of smoking abstinence will alter sleep, daytime alertness, and smoking behavior and craving for cigarettes. Sleep will be monitored using a sleep-tracking device, a sleep diary, and daytime alertness will be monitored using a performance metric (psychomotor vigilance task) three times per week for the 3 week study. Participants will also complete several other questionnaires related to smoking behaviors, craving, withdrawal, daytime sleepiness, and mood.
- Being tested
- Daridorexant 50 mg, Placebo
- Keywords
- Insomnia, Daridorexant, Smoking, Nicotine, Tobacco, Sleep, Addiction, Substance use disorders
- Medical subject headings
- Smoking, Behavior, Addictive, Substance-Related Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daridorexant 50 mgDrug
Active daridorexant vs placebo comparator in smokers with insomnia
PlaceboOther
Placebo in Smokers
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Not described Receives: Drug: Daridorexant 50 mg |
| No treatment | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep device to assess: latency to sleep, number of awakenings during the night, and sleep stages.
Measured: 2 days + 3 weeks study: 2 days to assess sleep prior to taking daridorexant followed by 3 weeks of daily daridorexant administration.
Daytime alertness
Assess daytime alertness using a 5 min psychomotor vigilance task. Higher score indicates lower alertness.
Measured: Assessed 3 times per day (morning, midday, evening), 3 times per week for 3 weeks.
Insomnia Severity Index
Assesses extent of insomnia. Range is 0-28. Higher score indicates high level of insomnia.
Measured: Assess at prescreening and on last day of the study (3 weeks and 2 days)
Sleep Quality-sleep diary
Daily sleep diary to assess self-reported sleep
Measured: Assessed 2 days prior to taking daridorexant and daily for 3 weeks during daily daridorexant administration.
Pittsburgh Sleep Quality Index
Assesses sleep quality (duration, disturbance, latency) over last 1 month. Range is 0-21; higher score indicates worse sleep quality.
Measured: 2 days before beginning study medication.
PROMIS Sleep-Short Form 8a
Assesses sleep quality over last 7 days. Range is 8-40, higher score indicates worse sleep/low alertness.
Measured: 2 days before beginning study medication and last day of weeks 1, 2, 3.
Karolinska Sleepiness Scale
Assesses daytime alertness - single question. Range is 1-10. Higher score indicates lower alertness.
Measured: Given 3X/day on days 3, 5, 7 of weeks 1, 2, 3.
Secondary outcomes (5)
Fagerstrom
Assesses extent of nicotine dependence. Range is 0-10. Higher score indicates higher dependence.
Measured: Measure at pre-screening and at the end of each week for 3 weeks.
Smoking History and Habits
Must smoke 10 or more cigarettes per day.
Measured: Measure at pre-screening.
Minnesota Scale Withdrawal from Nicotine
Assesses nicotine withdrawal symptoms over last 24 hr. Range is 0-60, higher score indicating higher withdrawal signs/symptoms.
Measured: 2 days before beginning study medication, end of day on days 3, 5, 7 of weeks 1, 2, and 3.
QSU Brief Smoking Desire
Assesses desire to smoke. Range 7-49. Higher score indicates higher craving to smoke.
Measured: End of day on days 3, 5, 7 of weeks 1, 2, and 3.
Number of cigarettes/vape products smoked
Daily Sleep Diary includes number of cigarettes/vape products smoked.
Measured: Reported daily for entire study (2 days + 3 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Feb 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University
- Responsible party
- Principal investigator, Barbara A. Sorg, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328594
- Sponsor's protocol ID
- 2233
- Other IDs
- 750140603
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mauries S, Rolland B, Mallevays M, Catoire S, Zehani F, Sauvage K, Davido G, Lejoyeux M, Geoffroy PA. Conditions of sleep restoration after smoking cessation: A systematic review. Sleep Med Rev. 2025 Apr;80:102041. doi: 10.1016/j.smrv.2024.102041. Epub 2024 Dec 9.
PubMed 39893864Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.
PubMed 36098936Fragale JE, James MH, Avila JA, Spaeth AM, Aurora RN, Langleben D, Aston-Jones G. The Insomnia-Addiction Positive Feedback Loop: Role of the Orexin System. Front Neurol Neurosci. 2021;45:117-127. doi: 10.1159/000514965. Epub 2021 May 28.
PubMed 34052815Hamidovic A. Dual Orexin Receptor Antagonists (DORAs) as an Adjunct Treatment for Smoking Cessation. CNS Drugs. 2022 May;36(5):411-417. doi: 10.1007/s40263-022-00918-0. Epub 2022 Apr 22.
PubMed 35451800Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.
PubMed 35065036
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking During Abstinence
- ClinicalTrials.gov ID
- NCT07328594
- Acronym / sponsor ID
- 2233
- Keywords
- Insomnia, Daridorexant, Smoking, Nicotine, Tobacco, Sleep, Addiction, Substance use disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Collaborators
- Washington State University
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tobacco use is the leading cause of preventable death in the U.S., with 480,000 deaths per year and 7.7 million deaths globally. A major clinical symptom associated with abstinence from both licit and illicit drugs is insomnia, which is a clinically verified, major risk factor for relapse. Roughly half of the 40 million smokers in the U.S. attempt to quit annually, with very low rates of success. One major hurdle is poor sleep quality during abstinence. Compounding the problem is that some pharmaceuticals to help reduce smoking can increase insomnia. Poor sleep is recognized as a major impediment to maintaining abstinence from several drugs of abuse, including nicotine. Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, and 80% report regular sleep disturbances, which can be amplified during abstinence. A new orexin blocker, daridorexant, was FDA approved within the past two years for the treatment of insomnia, and while it has been tested in healthy individuals with insomnia, it has not been tested in smokers, who suffer from insomnia, particularly during the withdrawal phase when trying to quit. Daridorexant has an improved profile of beneficial effects for those with insomnia, the most notable advantage being its shorter duration of action that promotes daytime alertness, which is problematic for both active smokers and smokers during withdrawal. Poor sleep leads to daytime sleepiness, which often leads to smoking to maintain alertness.
Detailed description
The investigators will use a randomized, double-blind placebo-controlled design to determine how daridorexant given over 3 weeks of smoking abstinence will alter sleep, daytime alertness, and smoking behavior and craving for cigarettes. Sleep will be monitored using a sleep-tracking device, a sleep diary, and daytime alertness will be monitored using a performance metric (psychomotor vigilance task) three times per week for the 3 week study. Participants will also complete several other questionnaires related to smoking behaviors, craving, withdrawal, daytime sleepiness, and mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Daridorexant 50 mg |
| No treatment | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult participants who are cigarette smokers, 18-55 years of age.
- Smokers: greater than 10 cigarettes/day.
- Smoking for 1 year or longer.
- 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.
- Willingness to monitor sleep at home with an external device and maintain a simple sleep and smoking diary for 3 weeks.
Key exclusion criteria (15 listed)
- 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.
- 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.
- Are currently taking stimulants commonly used for ADHD, such as methylphenidate (Ritalin Concerta, Daytrana) or amphetamines (Adderall, Dexedrine, Vyvanse).
- Are currently taking anti-seizure drugs, including lamotrigine, pregabalin (Lyrica), or gabapentin (Neurontin, Horizant, or Gralise).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daridorexant 50 mgActive daridorexant vs placebo comparator in smokers with insomnia | Drug | Treatment |
| PlaceboPlacebo in Smokers | Other | No treatment |
Primary outcome
Sleep Quality
Time frame: 2 days + 3 weeks study: 2 days to assess sleep prior to taking daridorexant followed by 3 weeks of daily daridorexant administration.
Sleep device to assess: latency to sleep, number of awakenings during the night, and sleep stages.
Daytime alertness
Time frame: Assessed 3 times per day (morning, midday, evening), 3 times per week for 3 weeks.
Assess daytime alertness using a 5 min psychomotor vigilance task. Higher score indicates lower alertness.
Insomnia Severity Index
Time frame: Assess at prescreening and on last day of the study (3 weeks and 2 days)
Assesses extent of insomnia. Range is 0-28. Higher score indicates high level of insomnia.
Sleep Quality-sleep diary
Time frame: Assessed 2 days prior to taking daridorexant and daily for 3 weeks during daily daridorexant administration.
Daily sleep diary to assess self-reported sleep
Pittsburgh Sleep Quality Index
Time frame: 2 days before beginning study medication.
Assesses sleep quality (duration, disturbance, latency) over last 1 month. Range is 0-21; higher score indicates worse sleep quality.
PROMIS Sleep-Short Form 8a
Time frame: 2 days before beginning study medication and last day of weeks 1, 2, 3.
Assesses sleep quality over last 7 days. Range is 8-40, higher score indicates worse sleep/low alertness.
Karolinska Sleepiness Scale
Time frame: Given 3X/day on days 3, 5, 7 of weeks 1, 2, 3.
Assesses daytime alertness - single question. Range is 1-10. Higher score indicates lower alertness.
5 secondary outcomes
Fagerstrom
Time frame: Measure at pre-screening and at the end of each week for 3 weeks.
Smoking History and Habits
Time frame: Measure at pre-screening.
Minnesota Scale Withdrawal from Nicotine
Time frame: 2 days before beginning study medication, end of day on days 3, 5, 7 of weeks 1, 2, and 3.
QSU Brief Smoking Desire
Time frame: End of day on days 3, 5, 7 of weeks 1, 2, and 3.
Number of cigarettes/vape products smoked
Time frame: Reported daily for entire study (2 days + 3 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 39893864Mauries S, Rolland B, Mallevays M, Catoire S, Zehani F, Sauvage K, Davido G, Lejoyeux M, Geoffroy PA. Conditions of sleep restoration after smoking cessation: A systematic review. Sleep Med Rev. 2025 Apr;80:102041. doi: 10.1016/j.smrv.2024.102041. Epub 2024 Dec 9.
- Background: PubMed 36098936Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.
- Background: PubMed 34052815Fragale JE, James MH, Avila JA, Spaeth AM, Aurora RN, Langleben D, Aston-Jones G. The Insomnia-Addiction Positive Feedback Loop: Role of the Orexin System. Front Neurol Neurosci. 2021;45:117-127. doi: 10.1159/000514965. Epub 2021 May 28.
- Background: PubMed 35451800Hamidovic A. Dual Orexin Receptor Antagonists (DORAs) as an Adjunct Treatment for Smoking Cessation. CNS Drugs. 2022 May;36(5):411-417. doi: 10.1007/s40263-022-00918-0. Epub 2022 Apr 22.
- Background: PubMed 35065036Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daridorexant 50 mg in people with Smoking and Nicotine, run by Legacy Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara A. Sorg, PhD (503-413-1934, bsorg@downeurobiology.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 2 days + 3 weeks study: 2 days to assess sleep prior to taking daridorexant followed by 3 weeks of daily daridorexant administration.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07328594, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.