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

Summary

The primary aims of this study is to contrast the effectiveness of CBT-I and pharmacotherapy (lemborexant) compared to placebo on sleep and mental health outcomes in people with insomnia disorder and anxiety/depressive symptoms. In addition, the study will evaluate whether insomnia phenotypes (i.e., +/- 6hrs of sleep) at baseline moderate the effectiveness of the intervention on both sleep and mental health outcomes.

Timeline

Start

2025-04-01

Primary completion

2027-02

Completion

2027-02

Publications

• Chen SJ, Ivers H, Dang-Vu TT, Shapiro CM, Carney CE, Robillard R, Morin CM. Efficacy of cognitive behavioral therapy for insomnia and lemborexant medication for different subtypes of chronic insomnia: study protocol for a randomized controlled trial. BMC Psychiatry. 2025 May 9;25(1):470. doi: 10.1186/s12888-025-06878-1.

Drugs

Indications