Sublingual cyclobenzaprine in fibromyalgia: a profile of its use

As the first treatment approved for fibromyalgia in 15 years, sublingual cyclobenzaprine (TONMYA®) is a useful addition to treatment options for adults in the USA. Sublingual cyclobenzaprine represents a novel treatment approach that targets disturbed sleep whilst improving fibromyalgia symptoms. Sublingual administration produces diurnal fluctuations in cyclobenzaprine plasma concentrations, with peak plasma concentrations coinciding with the middle of the sleep phase. As demonstrated in placebo-controlled, phase III clinical trials in adults with fibromyalgia, sublingual cyclobenzaprine 5.6 mg once daily at bedtime reduces pain and improves patient-reported symptoms, including sleep quality and fatigue. Sublingual cyclobenzaprine is generally well tolerated, with the most common treatment-emergent adverse events (AEs) being oral mucosal reactions. In clinical trials, treatment with sublingual cyclobenzaprine was not associated with AEs commonly reported with other fibromyalgia therapies. Characterized by widespread pain, sleep disturbances, and fatigue, fibromyalgia is a complex chronic pain condition with incompletely understood mechanisms. Established treatments for fibromyalgia primarily target pain relief; although, many patients discontinue these treatments due to adverse events (AEs) or a lack of efficacy. Recently, development of new therapies has targeted improvements in sleep quality to improve fibromyalgia symptoms. Oral cyclobenzaprine formulations improved sleep quality in clinical trials but demonstrated limited efficacy for pain relief and were associated with AEs such as fatigue. Sublingual cyclobenzaprine (TONMYA®) was recently approved in the USA for the treatment of fibromyalgia in adults. With sublingual administration, cyclobenzaprine concentrations peak during the sleep phase and fall during the daytime. As demonstrated in phase III clinical trials, sublingual cyclobenzaprine 5.6 mg once daily at bedtime reduces pain and improves patient-reported symptoms, including sleep quality and fatigue. Sublingual cyclobenzaprine is generally well tolerated. The most common treatment-emergent AEs are oral mucosal reactions. As the first treatment approved for fibromyalgia in 15 years, sublingual cyclobenzaprine is a useful addition to treatment options for adults with fibromyalgia in the USA.