Ropinirole (Requip, GlaxoSmith-Kline), a non-ergot-based, second-generation dopamine agonist, was recently approved as a therapy for moderate-to-severe primary restless legs syndrome (RLS). Results from clinical trials suggest that it significantly improves symptoms and quality of life, compared with placebo, and it is well tolerated over the long term (up to 52 weeks).
The largest study of RLS to date, the Therapy with Ropinirole Efficacy and Tolerability in RLS US Study (TREAT RLS US), supports those findings. Compared with placebo, once-daily ropinirole (0.25-4 mg/day) reduced overall symptoms of RLS. Improvements were observed as early as the third day and the first week, even with low starting doses. Ropinirole was also more effective than placebo in reducing sleep disturbances.
Earlier studies showed that patients with RLS frequently become anxious and depressed. In the current study, a subset of ropinirole patients with mild anxiety symptoms, as well as a small subset of patients, also improved. Ropinirole directly stimulates dopamine receptors in the brain.