Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine
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By
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Seth Lederman
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Lesley M Arnold
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Ben Vaughn
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Jean M Engels
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Mary Kelley
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Gregory M Sullivan
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July 8, 2025
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Objective:
To evaluate the efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg for the treatment of fibromyalgia.
Key Findings:
- TNX-102 SL resulted in significantly greater reductions in pain compared to placebo (mean difference -1.8 vs -1.2, P < .001).
- Significant improvements were observed in all secondary endpoints (P ≤ .001).
- 81.0% of TNX-102 SL patients and 79.6% of placebo patients completed the trial.
Interpretation:
Bedtime TNX-102 SL treatment significantly improved fibromyalgia symptoms and was well tolerated, with most adverse events being mild and transient.
Limitations:
- The study duration was limited to 14 weeks.
- Generalizability may be limited to the specific population studied.
Conclusion:
TNX-102 SL 5.6 mg is effective in reducing core fibromyalgia symptoms and is generally safe, supporting previous findings of its efficacy.
