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In August 2025, the U.S. FDA approved sublingual cyclobenzaprine (Tonmya) for use in adults with fibromyalgia. The starting dose is 2.8 mg once daily at bedtime, which may be increased to 5.6 mg after 2 weeks.
Context: Cyclobenzaprine was first approved by the FDA in 1977 for “relief of muscle spasm associated with acute, painful musculoskeletal conditions.” Structurally similar to tricyclic antidepressants, this agent reduces muscle hyperactivity through action in the central nervous system. In recent years, limited data have suggested possible benefits for patients with fibromyalgia, thought to be mediated through improved sleep, and guidelines have weakly recommended this off-label use. Now, based on the results of three industry-funded p…