OBJECTIVES: To evaluate the effectiveness of pramipexole treatment in patients with primary Restless Legs Syndrome (RLS) and, secondarily, the effect on work productivity impairment associated with RLS. METHODS: This was an open-label, 12 week-prospective, non-controlled, non-interventional trial in patients with primary moderate to severe RLS being treated with the non-ergot dopamine agonist pramipexole by general practitioners and internists across Germany under routine conditions. Work productivity impairment was assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI), RLS severity was measured by the International RLS Study Group Rating Scale (IRLS). RESULTS: A total of 2,546 patients suffering from moderate to severe RLS were evaluated at 904 sites. The mean age of the patients was 64.8 years and 67.8 % were female. Median treatment duration was 92 days. Patients were starting with a median initial pramipexole dose of 0.088 mg/d, were flexibly titrated and had a final maintenance dose of 0.35 mg/d. RLS severity was significantly improved: IRLS mean score was 25.7 at baseline and 9.6 at the final visit. From the total population 539 patients (21.2 %) were in paid labour. The mean age of this sub-population was 52.1 years; 58.1 % were female. Impairment while working due to RLS was reduced by 30% (median) in a subgroup of 436 patients, who reported impairment at baseline. In 162 patients reporting ‘Missing from work due to health problems' at baseline, a 6.1 hours/week (mean) reduction at the final visit was assessed by the WPAI, which translates into an average reduction in productivity loss for working RLS patients of €1642 in Germany. CONCLUSION: Pramipexole showed to be highly effective in the treatment of RLS in routine care, as substantiated by IRLS. Work productivity was substantially increased and impairment while working due to RLS-symptoms was reduced in patients being in paid labour.