Lemborexant (Dayvigo)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Dayvigo should not be reimbursed by public drug plans for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
• In the initial submission in 2023, 2 randomized controlled trials (RCTs) (the SUNRISE 1 and SUNRISE 2 studies) were reviewed. The clinical benefit of Dayvigo was uncertain due to limitations or concerns, including an enriched population, inconsistent results, missing data, lack of control for multiplicity, absence of or failure to meet minimum important differences, not assessing patient-centred outcomes (e.g., anxiety, productivity, or relationships), and uncertainty in the safety profile of Dayvigo (i.e., somnolence, falls, dependence). Evidence from an indirect treatment comparison (ITC) was also assessed. It is uncertain whether Dayvigo offers a meaningful clinical benefit compared to other treatments used for insomnia due to several limitations.
• In the present resubmission, 2 real-world observational studies (i.e., Juday et al. and Hirata et al.) investigating the association between risk of falls and Dayvigo were submitted as additional evidence. The evidence from Juday et al. and Hirata et al. was uncertain to determine whether Dayvigo was associated with a lower risk of falls, compared to other medications, due to several limitations such as possible selection bias due to inclusion of current users only, bias due to misclassification of exposures and outcomes, and residual confounding. No other evidence was submitted to address gaps identified in 2023.
• Based on the evidence reviewed, it is uncertain whether Dayvigo offers a meaningful clinical benefit compared to other treatments used for insomnia.