Daridorexant Treatment for Chronic Insomnia in Restless Legs Syndrome

Abstract Background Insomnia is common in restless legs syndrome (RLS), significantly impairing quality of life. Dual orexin receptor antagonists (DORAs) have demonstrated efficacy in managing insomnia and RLS symptoms. Daridorexant is a recently approved DORA for insomnia disorder. Objectives Evaluate the effectiveness of daridorexant 50 mg/night in treating insomnia in patients with RLS. Methods This multicenter prospective observational study included 21 patients with RLS and insomnia, evaluated at baseline and after 3 months of treatment with daridorexant 50 mg/night using Insomnia Severity Index (ISI), International Restless Legs Syndrome Study Group Rating Scale (IRLS), Beck Depression Inventory–II (BDI‐II), and a visual analogue scale for sleep quality. Results Sixteen patients completed follow‐up. Significant improvements were observed at follow‐up in ISI ( P = 0.001), IRLS ( P = 0.001) and BDI‐II scores ( P = 0.001), and sleep quality ( P < 0.001). Conclusions Daridorexant 50 mg/night improved insomnia, RLS, depressive symptoms, and sleep quality in RLS patients, supporting its potential use in this population.