BACKGROUND: Restless legs syndrome (RLS) is a potentially debilitating sleep disorder that affects a significant percentage of North American and European adults. Although standardized RLS diagnostic criteria are now established and widely accepted, reported prevalence estimates have varied widely. In this paper, we review the literature regarding RLS prevalence in North American and Western European adult populations, examine potential sources of variation, briefly discuss the impact of RLS, and offer recommendations for future research. METHODS: To identify qualifying studies, we searched 6 scientific databases and scanned bibliographies of relevant review papers and all identified articles. Studies including fewer than 300 participants, that did not use any of the 4 standard diagnostic criteria, were published prior to 1995 or targeted clinical populations were excluded. RESULTS: Thirty-four papers detailing results of large, population-based studies in 16 North American and Western European countries met our inclusion criteria, including 5 multi-country studies (N=69,992 participants) and 29 single country studies (N=163,188 participants); all but one were cross-sectional. Reported general prevalence rates ranged from 4% to 29% of adults, averaging 14.5+/-8.0% across studies. Reported prevalence averaged higher in primary care populations than in populations derived from random sampling or geographically defined cohorts (19.5+/-7.9% vs. 12.3+/-7.2%). Diagnostic and severity criteria differed considerably among studies, as did inclusion criteria, with corresponding variation in prevalence estimates. Prevalence averaged higher in women and older adults; more limited data suggest race/ethnicity, parity, health status, and other factors may also contribute to the observed variation in prevalence. RLS has profound, negative effects on health, well-being, and quality of life, yet detection rates remain low. CONCLUSIONS: Collectively, these studies indicate that RLS is a common disorder of major clinical and public health significance in the Western industrialized world, affecting between 4% and 29% of adults. The wide variation in reported prevalence likely reflects differences in demographic factors, health status, and other population characteristics; study population source and sampling frame; and inconsistencies in RLS diagnostic criteria and procedures. Prospective studies and corresponding incidence data on RLS are lacking, hindering the evaluation of both causal factors and sequelae.
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