FDA Approves Tonmya: First Nonopioid Sublingual Treatment Targeting Sleep in Fibromyalgia

Highlight

• The FDA has approved Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for adults with fibromyalgia, marking the first new therapy in over 15 years.
• Tonmya acts by targeting nonrestorative sleep, a central contributor to fibromyalgia symptoms including pain, fatigue, and cognitive dysfunction.
• Phase 3 trials (RELIEF and RESILIENT) involving nearly 1000 patients demonstrated significant reductions in daily pain intensity and improvements across multiple symptom domains after 14 weeks of once-nightly use.
• Adverse effects were predominantly local, transient, and manageable, supporting the drug’s favorable safety profile.

Study Background and Disease Burden