First FDA-Approved Fibromyalgia Treatment in 15 Years Reaches Pharmacies

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For the first time in more than 15 years, people living with fibromyalgia have a new U.S. Food and Drug Administration (FDA)-approved treatment option. Cyclobenzaprine HCl sublingual tablets (Tonmya), a nonopioid medication taken once nightly at bedtime, is now available by prescription in pharmacies across the U.S.

Fibromyalgia is a chronic condition that causes widespread pain, fatigue, poor sleep and a range of symptoms that can deeply affect daily life. It’s estimated to affect 10 million people living in the U.S., approximately 80% of whom are women. Until now, treatment options have been limited and often involve medications that may cause bothersome side effects or do not provide enough relief. Tonmya offers a new approach: It is a sublingual form of cyclobenzaprine, meaning it dissolves under the tongue for quicker absorption, and it is designed to help improve sleep quality while reducing pain.

“We are honored to bring this new treatment option to patients in partnership with the full fibromyalgia community including researchers, patients and investigators,” said Seth Lederman, M.D., chief executive officer of Tonix Pharmaceuticals. “We are excited and motivated to make Tonmya accessible to as many patients as possible.”

What the Research Shows

Tonmya was approved by the FDA in August 2025 based on results from two large Phase 3 clinical trials involving nearly 1,000 people, as well as supporting data from a third trial. These studies compared Tonmya with placebo over 14 weeks, focusing on pain reduction and improvements in daily functioning.

Key findings include the following:

• Significant pain reduction: Participants taking Tonmya had consistently greater decreases in daily pain scores than those taking placebo.
• Meaningful improvement: More patients on Tonmya achieved at least a 30% improvement in pain, which is considered a clinically meaningful response.
• Benefits beyond pain: Tonmya also improved sleep disturbance, fatigue, overall symptoms and patients’ global impressions of how they were feeling.
• Generally well tolerated: Across more than 1,400 treated patients in three clinical trials, Tonmya showed a favorable safety profile. The most common side effects were mild and included temporary numbness or tingling in the mouth, dry mouth, drowsiness or altered taste.

Why This Matters for Patients

“For years, fibromyalgia patients have struggled with limited treatment options that often fall short. The availability of Tonmya marks a meaningful advancement by targeting neurotransmitters thought to be involved in fibromyalgia,” said Andrea L. Chadwick, M.D., M.Sc., FASA, professor in the Department of Anesthesiology, Pain and Perioperative Medicine at the University of Kansas Health System.

With Tonmya now available in pharmacies nationwide, patients can discuss with their health care providers whether this newly approved therapy is an appropriate option for their symptoms and overall treatment plan.

“We’re truly excited about this new option for people living with fibromyalgia,” said Sharon Waldrop, patient and founder of the Fibromyalgia Association of Michigan. “The availability of Tonmya provides new hope for our community and represents a crucial step forward in fibromyalgia treatment.”