Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome

Abstract

Study Objectives: Polysomnographic study evaluating the efficacy of ropinirole for the treatment of patients with restless legs syndrome (RLS) suffering from periodic leg movements in sleep (PLMS). Design: Double-blinded, placebo-controlled, parallel-group study. Setting: 15 tertiary referral centers in the USA. Participants: 65 patients with RLS and PLMS. Interventions: Ropinirole (0.25-4.0 mg per day) or placebo for 12 weeks. Measurements and Results: Data from 59 patients were included in the primary endpoint analysis. PLMS per hour decreased more with ropinirole (48.5 to 11.8), compared with placebo (35.7 to 34.2; adjusted treatment difference: -27.2; 95% confidence interval [CI]: -39.1.-15.4; P < .0001). Periodic limb movements with arousal per hour decreased from 7.0 to 2.5 with ropinirole but increased from 4.2 to 6.0 with placebo (adjusted treatment difference: -4.3, 95% CI: -7.6.-1.1; P = .0096). Periodic limb movements while awake per hour decreased from 56.5 to 23.6 with ropinirole but increased from 46.6 to 56.1 with placebo (adjusted treatment difference: -39.5; 95% CI: -56.9.-22.1; P < .0001). Ropinirole treatment significantly improved patients' ability to initiate sleep (P < .05) and the amount of Stage 2 sleep compared with placebo (P < .01). No serious adverse events occurred in either group. Conclusions: Ropinirole is effective in the treatment of both the sleep and waking symptoms of RLS.