Real-world findings of daridorexant in chronic insomnia: A pilot study on subjective and actigraphic sleep parameters

The real-world effectiveness of daridorexant is scarcely documented, with limited studies investigating factors that may modify its effectiveness and its possible influence on sleep misperception. This observational study aims at: (i) investigating the real-world effectiveness of daridorexant through a wide range of subjective sleep assessment methods and actigraphy, (ii) measuring changes in sleep misperception during daridorexant treatment; (iii) exploring daridorexant effect modifiers. Sleep data were collected at baseline (T0) and after 1 month (T1) and 3 months (T2) of treatment for 28 patients. Misperception indexes were determined by calculating the misalignment between subjective and objective measurements. Potential modifiers like age, sex, Body Mass Index (BMI), disease duration, and treatment regimen were explored. Reported and actigraphic total sleep time (TST) and sleep efficiency (SE) showed a statistically significant increase across the treatment period. Median TST misperception decreased from -1.96 h at T0 to -0.57 h at T2, and SE misperception improved from -19% to -7%. Self-reported sleep disturbances and daytime symptoms showed notable improvement, with an 8-point reduction in the Insomnia Severity Index and significant decreases in the Insomnia Daytime Symptoms and Impacts Questionnaire scores. Only one non-serious adverse event (sleep paralysis) was reported. Age, sex, BMI, and disease duration influenced treatment effectiveness. Overall, these findings provide preliminary real-world evidence of associations between daridorexant use and subjective and objective sleep parameters. The observed signals, particularly regarding sleep misperception, should be considered hypothesis-generating and require confirmation in larger, controlled studies.