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.
Age range
18 Years – 55 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Sleep Quality
Timeframe: 2 days + 3 weeks study: 2 days to assess sleep prior to taking daridorexant followed by 3 weeks of daily daridorexant administration.
Daytime alertness
Timeframe: Assessed 3 times per day (morning, midday, evening), 3 times per week for 3 weeks.
Insomnia Severity Index
Timeframe: Assess at prescreening and on last day of the study (3 weeks and 2 days)
Sleep Quality-sleep diary
Timeframe: Assessed 2 days prior to taking daridorexant and daily for 3 weeks during daily daridorexant administration.
Pittsburgh Sleep Quality Index
Timeframe: 2 days before beginning study medication.
PROMIS Sleep-Short Form 8a
Timeframe: 2 days before beginning study medication and last day of weeks 1, 2, 3.
Karolinska Sleepiness Scale
Timeframe: Given 3X/day on days 3, 5, 7 of weeks 1, 2, 3.