Objective: To review the efficacy, safety, and tolerability of a sublingual formulation of cyclobenzaprine for the treatment of fibromyalgia. Data Sources: A literature search was conducted through PubMed and DrugBank using the following terms: cyclobenzaprine, fibromyalgia, sublingual, Tonmya, and TNX-102 SL. Study Selection and Data Extraction: Articles describing the pharmacology, pharmacokinetics, efficacy, safety, and/or tolerability of sublingual cyclobenzaprine were included in this review. Data Synthesis: Cyclobenzaprine is a tricyclic antidepressant like agent which exhibits sedative and muscle relaxant effects in the treatment of fibromyalgia. Clinical trials have demonstrated improvements in daily pain scores compared with placebo. Common adverse events associated with this agent include oral hypoesthesia, oral paresthesia, and abnormal taste. Conclusions: Pharmacologic agents receive a weak recommendation for use in the treatment guidelines and include agents such as duloxetine, pregabalin, tramadol, amitriptyline, and a nonsublingual formulation of cyclobenzaprine. Tonmya, the newest agent approved for fibromyalgia, provides clinicians with an additional treatment option in a convenient dosage form for this potentially debilitating condition.
Onge et al. (Tue,) studied this question.