08/29/2025
As a rheumatologist, I know firsthand how challenging it can be to treat fibromyalgia. Even with FDA-approved medications like Cymbalta, pregabalin, and Savella, we often need to rely on off-label options, supplements, and integrative therapies to help our patients.That’s why I’m particularly excited about a new FDA-approved option as of August 15, 2025—the first major approval for fibromyalgia treatment in 15 years! What makes this especially promising is that it’s a sublingual medication. From a rheumatology standpoint, absorption is key to efficacy, and a sublingual option can reduce systemic side effects while providing faster relief.This new treatment is sublingual cyclobenzaprine, designed to be taken at bedtime for maximum benefit. Many of us have prescribed oral cyclobenzaprine for fibromyalgia in the past, but its use has often been limited by side effects.In clinical trials with 457 patients, those taking the sublingual form experienced significant improvements in pain, sleep disruption, fatigue, and “fibro fog”, with fewer side effects than the oral version. Importantly, it did not cause weight gain like some other options, such as pregabalin.The company anticipates this medication will be available within the next 3 months, so patients may be able to get a prescription by the end of this year. Pricing has not yet been confirmed, but it’s expected to be expensive. Hopefully, given the limited options for fibromyalgia, insurance companies will work to make it more accessible.