What Is Tonmya, the First New Fibromyalgia Treatment in 15 Years?

The FDA approved Tonmya, a non-opioid bedtime tablet that dissolves under the tongue, after two phase 3 trials found measured pain improvement. Ask your doctor whether it fits your care.

On October 2, the FDA approved Tonmya (sublingual cyclobenzaprine HCl), the first new fibromyalgia treatment option in more than 15 years. The non-opioid tablet dissolves under the tongue at bedtime and is intended to address both chronic pain and disrupted sleep. Approval drew on two large phase 3 trials involving nearly 1,000 patients; many reported pain reductions of at least 30% after three months compared with placebo.

That is meaningful progress for a condition affecting more than 10 million U.S. adults, most of them women, but it is measured improvement rather than complete relief. This approval is news, not a personal treatment recommendation, so ask your own clinician whether Tonmya fits your symptoms, medicines, and health history. This tip is general information only, not medical advice.