Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3 months follow‐up

Summary Insomnia disorder may affect mental health, increasing suicidal risk. Targeting insomnia is crucial in the clinical practice. Sixty‐six consecutive patients with insomnia disorder according with the DSM‐5‐TR criteria were treated with the dual orexin receptor antagonist, daridorexant 50 mg. Baseline (T0), 1 month (T1) and 3 month (T2) evaluations were performed. Insomnia severity (Insomnia Severity Index), mood, anxiety symptoms and suicidal risk (Beck Depression Inventory‐II, Young Mania Rating Scale, Self‐Reported Anxiety Scale, Suicidal Ideation Scale), dysfunctional insomnia‐cognitive factors and pre‐sleep arousal (Dysfunctional Beliefs About Sleep, Pre‐Sleep Arousal Scale) were evaluated. The final sample included 66 patients (n = 36, 54% females, mean age 60 ± 13.6 years). Most of them, 64%, suffered from insomnia disorder comorbid with unipolar/bipolar depression, anxiety disorders and substance use disorders. Repeated ANOVA analyses showed that Insomnia Severity Index, Dysfunctional Beliefs About Sleep and Pre‐Sleep Arousal Scale total score decreased across time (F = 68.818, p