The primary characteristics of restless legs syndrome (RLS), including severe sleep disorders, restlessness in the evening and discomfort while at rest, have substantial impact on normal daily activities. Because of the high prevalence of RLS in the general population, it is necessary to evaluate the economic impact of RLS. To determine the health economic burden of patients with RLS in Germany. A total of 519 RLS patients (mean age: 65.2 +/- 11.1 years) in different stages of disease were recruited in five health centres (university hospitals, district hospitals and office-based neurologists) by applying the diagnostic criteria of the International Restless Legs Syndrome Study Group. A questionnaire was administered that assessed healthcare resource consumption as well as socioeconomic, demographic, clinical and health status. In addition, the International RLS severity scale (IRLS), Epworth Sleepiness Scale (ESS), EQ-5D and Beck Depression Inventory (BDI) were addressed in the assessment. Direct and indirect costs (euro, year 2006 values) were derived from various German economic resources and calculated from the perspective of the healthcare and transfer payment providers. We calculated average total costs over the 3-month observation period. It was determined that average total costs were euro2090 for this period. The average direct medical and non-medical costs from the perspective of the health insurance provider were determined to be euro780, with euro300 attributed to drug costs and euro354 to hospitalization costs. Average total indirect costs amounted to euro1308 and were calculated based on productivity loss, using the human capital approach. As cost-driving factors we identified disease severity according to the IRLS (p < 0.01) and ESS (p < 0.04). Health-related quality of life was determined to be substantially affected by RLS; the mean EQ-5D visual analogue scale (VAS) was 55.6, considerably lower than that of the age-matched general population. RLS places a notable financial burden on society as well as on patients and their families. More detailed studies are needed to evaluate the health economic impact of this disorder.

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