Comparing CBT-I and Lemborexant for Chronic Insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) and the medication lemborexant compared to a placebo in treating insomnia disorder, particularly in individuals with anxiety and depressive symptoms. Participants will be randomly assigned to one of three groups: CBT-I, lemborexant, or placebo, over an 8-week treatment period. The study will also assess how different insomnia phenotypes, based on sleep duration, influence treatment outcomes. Assessments will occur at baseline, post-treatment, and at a 6-month follow-up to measure changes in sleep and mental health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years of age or older at the time of enrolment
* Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder (Duke Sleep Interview), with total Insomnia Severity Index (ISI) score \> 10, and score ≥ 2 on either the interference or distress item
* Minimal symptoms of anxiety and/or depression with Patient Health Questionnaire (PHQ-9) \> 4 and/or Generalized Anxiety Disorder (GAD-7) \> 4
* Ability to read and understand French or English
* Ability to use a smartphone, tablet, or computer, and access to home internet connection

Exclusion Criteria:

* Presence of a lifetime diagnosis of any psychotic or bipolar disorder
* Untreated psychiatric disorder (e.g., major depression) or risk for suicide
* Substance/alcohol use disorder within the past year
* Any life-threatening or progressive medical illness (e.g., cancer, chronic obstructive pulmonary disease) or neurological degenerative disease (e.g., dementia)
* Current use of sleep-promoting medications (prescribed or over-the-counter) or cannabis-derived products for sleep more than two nights per week
* Current use of tricyclic antidepressants, monoamine oxidase inhibitors, or atypical antidepressants
* Reported diagnosis of sleep disorder other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, rapid eye movement behavior disorder, delayed phase sleep disorder, narcolepsy)
* Total score \> 5 on the Stop-Bang Questionnaire and/or clinical symptoms suggestive of sleep apnea (excessive daytime sleepiness), or Epworth score \> 10, restless legs syndrome or other signs of other sleep disorders
* Atypical sleep schedules (i.e., habitual bedtimes later than 2:00 AM and rising times later than 10:00 AM on more than two days/nights per week as documented from a sleep diary)
* Working night shifts more than five nights per month in the last six months
* Consuming 2 or more alcoholic beverages per day regularly (3 days or more per week)
* Any contra-indications to using the study medication, including lung disease/breathing problems (e.g., chronic obstructive pulmonary disease), use of strong or moderate CYP3A inducers (strong - rifampin, carbamazepine, and St. John's Wort) (moderate - bosentan, efavirenz, etravirine, and modafinil), pregnant and breastfeeding women
* Not using any method of birth control

Where it's running

• Université Laval Centre d'étude des troubles du sommeil
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Charles M Morin, PhD — Université Laval Centre d'étude des troubles du sommeil
• Study coordinator: Manon Lamy
• Email: manon.lamy@psy.ulaval.ca
• Phone: 418-656-2131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.