Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

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