A phase 3 randomized, double-blind trial evaluated the efficacy of once-nightly sublingual cyclobenzaprine 5.6 mg in reducing fibromyalgia pain. Conducted across 33 US sites with 457 adults, the study showed significant pain reduction compared to placebo at week 14, along with improvements in sleep and fatigue symptoms. Key secondary endpoints, including patient-reported outcomes, also favored the active treatment group. Though some treatment-emergent adverse events were reported, they were largely mild. This trial supports cyclobenzaprine as a viable option for fibromyalgia management.

Source: Pain Medicine