A Preliminary Report on the Effects of Daridorexant in Patients with Comorbid Insomnia and Substance Use Disorders.

Abstract

Background. Sleep disturbances are frequent in patients with substance use disorders (SUDs) and are associated with craving and addiction relapses, leading to increased clinical severity and detrimental outcomes. Daridorexant, a selective dual orexin receptor antagonist, has been approved for persistent insomnia disorder (ID), but specific insights on patients with SUDs are lacking. Methods. This observational, retrospective study investigated the effects of a three-month treatment with daridorexant (50 mg/day) in 41 outpatients with comorbid IDs and SUDs. Improvement in subjective sleep measures, assessed with the Insomnia Severity Index (ISI) and subjective total sleep time, was the primary outcome measure. Changes in anxiety and depression symptoms, quality of life, clinical global severity, and craving were also investigated through the following: Hamilton Anxiety and Depression Rating Scale; Five-item World Health Organization Well-Being Index; Clinical Global Impression Severity Scale; Visual Analog Scale for Craving. Results. All sleep outcomes significantly improved throughout treatment, which was generally safe and well tolerated, with mild and transient drowsiness and sluggishness reported in 21.1% of patients. Similar improvements were observed in psychopathology, quality of life, and craving, and positive correlations were found among ISI scores and anxiety/depression symptoms and craving. An abstinence rate (i.e., absence of any substance use, regardless of the amount, throughout treatment) of 65.8% was also detected at the endpoint. Conclusions. These preliminary findings suggest that daridorexant might represent a promising tool for treating insomnia in patients with SUDs. Identifying interventions effectively targeting insomnia with a good safety/tolerability profile in SUDs is crucial to achieve remission and full functional recovery.