Daridorexant Treatment for Chronic Insomnia in Restless Legs Syndrome

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.