Tonmya

Tonmya is a proprietary **sublingual formulation of cyclobenzaprine hydrochloride** developed by Tonix for the **treatment of fibromyalgia in adults**. It was approved by the U.S. FDA in **August 2025** for this indication. Tonmya is designed for **once-daily bedtime administration** as a rapidly absorbed sublingual tablet that partially bypasses first-pass hepatic metabolism, reducing formation of the long-lived active metabolite norcyclobenzaprine relative to conventional oral cyclobenzaprine formulations. Cyclobenzaprine is a **small-molecule tricyclic antidepressant-like agent**; for fibromyalgia, the **precise mechanism of action is not established**, but in vitro pharmacology shows functional antagonism at **M1 muscarinic acetylcholine, H1 histamine, alpha-1 adrenergic, and 5-HT2A serotonin receptors**. Clinically, the product is positioned as a non-opioid therapy intended to improve core fibromyalgia symptoms including **pain, sleep disturbance, and fatigue**.

Brand names

Tonmya

Other names

cyclobenzaprine hydrochloride sublingual tabletscyclobenzaprine HCl sublingual tablets