Cyclobenzaprine Sublingual (Tonmya): A New Era in Fibromyalgia Therapy”

Fibromyalgia is a chronic pain disorder characterized by widespread pain, non-restorative sleep,
and fatigue. Current therapies offer limited relief, highlighting the need for new options. Tonmya
(TNX-102 SL), a sublingual bedtime formulation of cyclobenzaprine hydrochloride, was
developed to improve absorption, reduce metabolite exposure, and target both pain and sleep
disturbance.
More than 1,000 adults with fibromyalgia were recruited for two Phase III trials (RELIEF and
RESILIENT) that were randomized, double-blind, and placebo-controlled. Patients received
Tonmya 2.8 mg nightly for two weeks, followed by 5.6 mg nightly, or placebo for 14 weeks. The
primary outcome was change in daily pain intensity at Week 14, with secondary variables
including sleep quality, exhaustion, function, and patient global impression. Tonmya consistently
improved sleep disturbance, tiredness, and functional outcomes while also considerably reducing
pain when compared to a placebo. There were no significant safety issues identified, and the
adverse effects, which included taste changes, sleepiness, and oral hypoesthesia, were mostly
minor and localized. The first non-opioid, sublingual treatment for fibromyalgia to receive FDA
approval was Tonmya in August 2025, offering a fresh approach to all-encompassing symptom
management.
Keywords: Fibromyalgia, Tonmya, TNX-102 SL, cyclobenzaprine, sublingual tablet, non-opioid,
chronic pain, sleep disturbance, fatigue.