OBJECTIVES: Payers may employ utilization management tools that restrict access to FDA-approved therapies in favor of off-label therapies for treating disorders such as fibromyalgia (FM). It is appropriate to review the body of evidence that exists to support these decisions. We assessed the quality and quantity of published randomized clinical trials (RCTs), as well as reviewed the trial evidence presented in compendia and guidelines, for commonly prescribed FM treatments. METHODS: A literature review was conducted using MEDLINE, Cochrane Library, and EMBASE for FM RCTs published January 2000 to June 2009. Two raters reviewed the quality of each RCT using the Jadad Quality Score. RCTs published prior to 2000 and cited in systematic reviews with published Jadad scores supplemented the review. Trial evidence cited in Drugdex and AHFS-DI compendia and the 2005 American Pain Society (APS) guideline were also reviewed. RESULTS: The 2000-2009 literature review yielded 19 RCTs; the supplemental review yielded an additional 14 RCTs. When comparing across FM treatments, the FDA-approved therapies reported high-quality scores and had many more study subjects reported in published RCTs compared to off-label therapies. A review of compendia showed pregabalin was the only FM therapy cited in both Drugdex and AHFS-DI. However, the APS guideline, last updated in 2005, recommended off-label therapies and cited gabapentin and the FDA-approved pregabalin as “experimental” treatments for FM. The off-label therapies nortriptyline and cyclobenzaprine were not listed as treatments for FM in either compendia, and many off-label and FDA-approved therapies were not specifically cited in the guideline. CONCLUSIONS: Formulary decision-makers should carefully consider the currency and quality of the body of evidence cited in compendia and guidelines, and should compare listings to recent high-quality published RCTs when considering utilization management tools for the treatment of FM.