Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting

Daridorexant 50 mg is administered once daily at bedtime, either as monotherapy or as add-on therapy in patients with chronic insomnia. The intervention is evaluated in a naturalistic, real-world setting over a 3-month observational period. Both subjective (questionnaires, sleep diary) and objective (actigraphy) sleep parameters are collected at baseline, 1 month, and 3 months. Actigraphy is used to assess total sleep time, sleep efficiency, wake after sleep onset, and circadian rhythm parameters. Sleep misperception is calculated as the discrepancy between subjective and objective sleep metrics. The study also explores potential predictors of treatment response such as age, sex, BMI, insomnia duration, and comorbid sleep disorders.