What is the new medication for fibromyalgia?

October 7, 2025 •

4 min read

In August 2025, the U.S. Food and Drug Administration (FDA) approved Tonmya (sublingual cyclobenzaprine), the first new medication for fibromyalgia in over 15 years, offering renewed hope for millions affected by this chronic condition. This development marks a significant advancement in pharmacological treatment options, specifically targeting the non-restorative sleep that often accompanies the widespread pain of fibromyalgia.

Quick Summary

The new FDA-approved fibromyalgia medication, Tonmya (sublingual cyclobenzaprine), addresses pain and sleep disturbances through a novel delivery method. Clinical trials indicate it significantly reduces daily pain and improves sleep quality for many adult patients. It is expected to be available in late 2025.

Key Points

FDA Approval: Tonmya, a sublingual cyclobenzaprine tablet, received FDA approval in August 2025 for treating fibromyalgia.
Novel Delivery Method: The medication is taken under the tongue, allowing for rapid absorption and reduced systemic side effects compared to older oral cyclobenzaprine.
Mechanism: Tonmya primarily targets non-restorative sleep, helping to improve sleep quality which in turn reduces pain and fatigue.
Proven Efficacy: Clinical trials demonstrated statistically significant reductions in daily pain and improvements in sleep and overall function.
Potential First-Line Option: As the first new drug in over 15 years, it is expected to be considered a potential first-line therapy option for adults with fibromyalgia.
Complementary Therapies: Effective management still relies on a multimodal approach, combining medication with non-pharmacological treatments like exercise and CBT.

Understanding the New Fibromyalgia Medication: Tonmya

FDA Approves First New Fibromyalgia Drug in 15 Years

In August 2025, the U.S. Food and Drug Administration (FDA) approved Tonmya (cyclobenzaprine HCl sublingual tablets), marking the first new pharmacological treatment specifically for fibromyalgia in over 15 years. Developed by Tonix Pharmaceuticals, this novel, non-opioid medication offers a new therapeutic pathway for adults living with the chronic pain, fatigue, and sleep disturbances associated with the condition. The approval was based on positive results from two large-scale Phase 3 clinical trials, RELIEF and RESILIENT, which demonstrated its efficacy and safety. Tonmya is expected to be available in the United States by the end of 2025.

How Does Tonmya Work? The Science Behind the Sublingual Delivery

Tonmya is not an entirely new compound, but rather a reformulated version of cyclobenzaprine, a tricyclic drug used for decades as a muscle relaxant. The key innovation lies in its sublingual (under the tongue) delivery system. This method offers several advantages over traditional oral pills.

Unlike swallowed tablets, the sublingual formulation dissolves and is absorbed directly into the bloodstream, bypassing the liver's first-pass metabolism. This process reduces the production of norcyclobenzaprine, a long-lasting and often side-effect-causing metabolite of oral cyclobenzaprine. By minimizing the impact of this metabolite, Tonmya aims to provide the therapeutic benefits of cyclobenzaprine while potentially reducing common side effects like daytime drowsiness and dizziness.

Tonmya's mechanism is thought to primarily target non-restorative sleep, a core symptom of fibromyalgia. It acts on specific brain receptors involved in sleep and pain pathways. By improving the quality of sleep, the medication helps to alleviate the widespread pain and fatigue that are hallmarks of fibromyalgia.

Efficacy and Side Effects from Clinical Trials

Clinical trial results highlighted Tonmya's benefits in managing key fibromyalgia symptoms:

Pain Reduction: In the pivotal RESILIENT trial, patients taking Tonmya showed a significant reduction in their daily pain scores compared to those on a placebo over 14 weeks. A meaningful portion of patients experienced at least a 30% reduction in their pain.
Improved Sleep and Function: The trials also demonstrated statistically significant improvements in sleep quality, reduction in fatigue, and better overall functioning.
Side Effect Profile: Tonmya was generally well-tolerated. The most frequent side effects were localized to the mouth, such as numbness, tingling, and abnormal taste. Systemic side effects were minimal, with headache and somnolence occurring in a low percentage of participants. This contrasts with the more common and significant side effects often associated with oral cyclobenzaprine.

Tonmya vs. Other FDA-Approved Fibromyalgia Medications

Tonmya joins a small group of FDA-approved drugs for fibromyalgia, including pregabalin, duloxetine, and milnacipran. These existing treatments operate on different mechanisms, and patient response can vary. The introduction of Tonmya provides a new option for patients who have not found sufficient relief with other therapies.


Feature	Tonmya (cyclobenzaprine)	Pregabalin (Lyrica)	Duloxetine (Cymbalta)	Milnacipran (Savella)
Mechanism	Sublingual cyclobenzaprine acts centrally to improve sleep quality, which reduces pain and fatigue.	An anticonvulsant that modulates pain-sensitive nerve activity.	A serotonin-norepinephrine reuptake inhibitor (SNRI) that alters pain transmission pathways.	An SNRI with proportionally greater noradrenergic reuptake inhibition than duloxetine.
Administration	Sublingual tablet, taken once daily at bedtime.	Oral capsule, taken 2-3 times daily.	Oral capsule, typically once daily.	Oral capsule, typically twice daily.
Common Side Effects	Mouth numbness/tingling, altered taste, tongue discomfort.	Dizziness, somnolence, weight gain, swelling.	Nausea, dry mouth, constipation, insomnia.	Nausea, headache, constipation, palpitations.
Availability	Expected late 2025.	Generic available.	Generic available.	Generic available.

The Importance of a Multimodal Treatment Approach

While a new medication provides a valuable tool, it is essential to remember that managing fibromyalgia often requires a comprehensive, multimodal approach. A treatment plan should be tailored to individual needs and typically includes both pharmacological and non-pharmacological strategies.

Non-pharmacological therapies for fibromyalgia include:

Exercise: Regular, low-impact activities such as walking, swimming, or yoga can significantly help reduce pain and improve physical function.
Cognitive Behavioral Therapy (CBT): This form of therapy can help patients develop coping strategies, manage pain perception, and address related issues like anxiety and depression.
Mindfulness and Stress Reduction: Practices like meditation and deep breathing can help reduce the impact of stress, a major trigger for fibromyalgia flare-ups.
Improved Sleep Hygiene: Establishing a consistent sleep schedule and a relaxing bedtime routine is crucial for complementing medication that targets sleep disturbances.

Other Investigational and Emerging Therapies

Beyond the newly approved Tonmya, research continues into other potential treatments for fibromyalgia:

Low-Dose Naltrexone (LDN): Naltrexone, an opioid receptor antagonist, is being investigated for its anti-inflammatory effects at very low doses. Some small studies suggest it may reduce pain and improve symptoms, though more robust research is needed.
Cannabinoids (THC/CBD): The use of cannabinoids is being explored for their potential to alleviate pain, improve sleep, and reduce anxiety associated with fibromyalgia.

Conclusion

The FDA approval of Tonmya represents a significant step forward for the fibromyalgia community, offering a new treatment option after a long period with limited advancements. Its sublingual delivery system offers a distinct approach, aiming to improve sleep quality and consequently reduce pain with a more manageable side effect profile than older oral alternatives. As with any chronic condition, the most effective management strategy will likely involve a combination of this new medication with existing therapies and non-pharmacological interventions, all guided by a healthcare provider. The emergence of Tonmya brings renewed optimism for a better quality of life for those living with fibromyalgia.

Disclaimer: This information is for general knowledge and should not be taken as medical advice. Consult with a healthcare professional before starting any new supplement regimen.

Frequently Asked Questions

The new medication for fibromyalgia is called Tonmya (cyclobenzaprine HCl sublingual tablets). It was approved by the FDA in August 2025 and is administered under the tongue once daily at bedtime.

Tonmya is expected to be available in the United States by the end of 2025.

Tonmya's sublingual delivery distinguishes it from older oral drugs like pregabalin, duloxetine, and milnacipran. This method bypasses the liver, resulting in potentially fewer systemic side effects, and focuses primarily on improving sleep quality to reduce pain.

The most common side effects reported in clinical trials were localized to the mouth, such as numbness, tingling, and an abnormal taste.

Tonmya is taken once daily at bedtime as a sublingual tablet that dissolves under the tongue. Specific instructions regarding initiation and adjustments should be followed as directed by a healthcare professional.

Coverage for new medications can vary by insurance company. When older medications were first approved, insurance coverage was sometimes initially challenging, and Tonmya may be expensive at first. Patients should check with their insurance providers regarding coverage and co-pay information.

A multimodal approach combining medication with therapies like exercise, cognitive behavioral therapy (CBT), and stress reduction is often most effective for managing fibromyalgia. Patients should consult with their healthcare provider to determine the best plan.

No, Tonmya is a non-opioid medication. It is a sublingual formulation of cyclobenzaprine, a muscle relaxant.