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Table 1 Eligibility criteria

From: Efficacy of cognitive behavioral therapy for insomnia and lemborexant medication for different subtypes of chronic insomnia: study protocol for a randomized controlled trial

Inclusion criteria

 1) 18 years of age or older at the time of enrollment

 2) 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

 3) Minimal symptoms of anxiety and/or depression with Patient Health Questionnaire (PHQ-9) > 4 and/or Generalized Anxiety Disorder (GAD-7) > 4

 4) Ability to read and understand French or English

 5) Ability to use a smartphone, tablet, or computer, and access to home internet connection

Exclusion criteria

 1) Presence of a lifetime diagnosis of any psychotic or bipolar disorder

 2) Untreated psychiatric disorder (e.g., major depression) or risk for suicide

 3) Substance/alcohol use disorder within the past year

 4) Any life-threatening or progressive medical illness (e.g., cancer, chronic obstructive pulmonary disease) or neurological degenerative disease (e.g., dementia)

 5) Current use of sleep-promoting medications (prescribed or over-the-counter) or cannabis-derived products for sleep more than two nights per week

 6) Current use of tricyclic antidepressants, monoamine oxidase inhibitors, or atypical antidepressants

 7) 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)

 8) Total score > 5 on the Stop-Bang Questionnaire and/or clinical symptoms suggestive of sleep apnea (excessive daytime sleepiness), or Epworth Sleepiness Scale (ESS) score > 10, restless legs syndrome or other signs of other sleep disorders

 9) 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)

 10) Working night shifts more than five nights per month in the last six months

 11) Consuming 2 or more alcoholic beverages per day regularly (3 days or more per week)

 12) 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

 13) Not using any method of birth control