Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial

I. Jon Russell, A. Thomas Perkins, Joel E. Michalek, Robert M. Bennett, Michelle Price, Adam Barron, Tammy Evans, Isam Diab, John Lacombe, Joseph S. Habros, Heather Yatabe, Andrew J. Holman, Robin Meyers, Alan Kivitz, Deb Morrisson, Elliot Kopp, Jane Downs, Philip Mease, Debbie Granner, Abigail NeimanDawn Fanguy, David Nordstrom, Robert Sturgeon, John Pappas, Judy Wilkinson, Ashwin Patkar, Kathryn Tarter, Wanda Haynes, David Seiden, Flora Rosen, Eric A. Sheldon, Mirnaya Alabaci, Stuart L. Silverman, Carol Joseph, N. Lee Smith, Tami Francisco, Daniel Wallace, Inga Arnold, Larry G. Willis, Andrea Craddock, John B. Winfield, Patricia Bradshaw, Patrick Wood, Laura Warren

    Research output: Contribution to journalArticlepeer-review

    122 Scopus citations


    Objective. To evaluate the safety and efficacy of sodium oxybate for management of the symptoms of fibromyalgia syndrome (FMS). Methods. Patients with FMS (according to the American College of Rheumatology 1990 criteria) were randomized, after discontinuing their prestudy medications for FMS, to receive 4.5 gm or 6 gm of sodium oxybate or matching placebo once per night for 8 weeks. The primary outcome variable (POV) was a composite score for changes from baseline in 3 coprimary self-report measures: patient's pain rating (in daily electronic diaries) on a visual analog scale (PVAS), the Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global Impression of Change (PGI-C). A beneficial response rate for the POV composite score was defined as ≥20% improvement in the PVAS and FIQ scores plus a rating of "much better" or "very much better" on the PGI-C. Secondary measures included subjective sleep outcomes (on the Jenkins Scale for Sleep) and quality-of-life measures. The analyses were based on an intent-to-treat (ITT) population. Results. The ITT population included 188 patients with FMS, 78% of whom completed the trial. Significant benefit was observed with both dosages of sodium oxybate, according to changes in the POV and subjective sleep quality. Improvements in the PVAS score were significantly correlated with sleep outcomes. Sodium oxybate was well tolerated overall; dose-related nausea (≤28% of patients) and dizziness (≤18% of patients) tended to resolve with continued therapy. Conclusion. Sodium oxybate therapy was well tolerated and significantly improved the symptoms of FMS. Further study of sodium oxybate as a novel therapeutic option for FMS is warranted.

    Original languageEnglish (US)
    Pages (from-to)299-309
    Number of pages11
    JournalArthritis and rheumatism
    Issue number1
    StatePublished - Jan 2009

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Rheumatology
    • Immunology
    • Pharmacology (medical)


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