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

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Insomnia Disorder
Interventions
BEHAVIORAL

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Participants in this treatment group will receive CBT-I. CBT-I sessions will occur weekly for the first 4 sessions and biweekly for the last 2 sessions (treatment phase is thus 8 weeks). : Graduate level students in clinical psychology will serve as therapists for this project.

DRUG

Lemborexant

Participants assigned to this group will be prescribed 5 to 10 mg of lemborexant to be taken at bedtime in 5 mg capsules. Lemborexant (Dayvigo) is a Dual Orexin Receptor Antagonist approved by Health Canada for the treatment of adult with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.

DRUG

Placebo

Participants assigned to this group will be prescribed 5 to 10 mg of placebo to be taken at bedtime in 5 mg capsules identical to lemborexant. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.

Trial Locations (1)

G1V 0A6

RECRUITING

Université Laval Centre d'étude des troubles du sommeil, Québec

All Listed Sponsors
collaborator

Toronto Metropolitan University

OTHER

collaborator

The Royal Ottawa Mental Health Centre

OTHER

lead

Laval University

OTHER