OBJECTIVES: To analyse hospital outpatient treatment patterns and costs associated with Restless Legs Syndrome (RLS) in Italy before the non-ergot derived dopamine agonist pramipexole was approved in the treatment of RLS. RLS is a common, although largely under-diagnosed, neurological disorder producing negative effects on patients' quality of life. METHODS: A retrospective database analysis was conducted using the database of the Sleep Disorders Centre of San Raffaele Hospital in Milan. The database records each patient's sleep disorder, baseline characteristics, drug prescriptions and medical procedures. 2,000 patients included in the database were screened in order to identify patients affected by RLS symptoms and to calculate resource use associated with the treatment of RLS from January 2004 to March 2005. RESULTS: In total, 122 patients (6% of all patients in the database) were diagnosed with RLS symptoms and consequently included in the study: mean age was found to be 52 years and 68% were women. All patients received at least three different drug classes over the observation period. The most frequently prescribed treatments were: benzodiazepines (64%), antidepressants (23%) anticonvulsants (4%), NSAIDS (4%) and oxerutines (5%). The total average cost per patient per year was € 289.09, including drug costs (€ 242.79), diagnostic tests (€ 32.67) and physician visits (€ 13.63). CONCLUSION: This was the first effort to evaluate hospital outpatient treatment patterns and costs for RLS in Italy. The majority of the annual treatment costs incurred by RLS patients were associated with currently unlicensed treatment options which can place an additional cost burden on the public healthcare system while treatment outcomes are limited.