The US approved TONMYA, a sublingual formulation of cyclobenzaprine, for adult fibromyalgia—marking the first new therapy for the disorder in 15 years. Evidence from placebo-controlled Phase 3 trials supported reductions in pain and improvements in patient-reported symptoms including sleep quality and fatigue when dosed at 5.6 mg once nightly. The sublingual route is designed to align exposure with the sleep phase, potentially differentiating it from earlier oral regimens and supporting a distinct clinical utility narrative centered on sleep disturbance. Clinicians and payers will likely focus on real-world tolerability, adherence expectations with the new delivery form, and durability of symptom improvements across diverse adult populations.