Sublingual cyclobenzaprine in fibromyalgia: a profile of its use

Funding The preparation of this review was not supported by any external funding.DeclarationsAuthorship and conflict of interest M. B. Brown and H. A. Blair are salaried employees of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable.Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/ licenses/by-nc/4.0/.Additional information about this Adis Drug Review can be found here Abstract 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.