Fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain, fatigue, and cognitive disturbances, continues to challenge both patients and healthcare providers. As of 2025, significant strides have been made in understanding its pathophysiology and developing innovative treatment modalities. This comprehensive overview delves into the latest advancements, expert insights, and emerging therapies shaping fibromyalgia management today.
Understanding Fibromyalgia: A Complex Condition
Fibromyalgia affects approximately 5% of the global population, with women comprising up to 96% of cases. The condition is marked by a range of symptoms, including:
- Widespread musculoskeletal pain
- Fatigue and sleep disturbances
- Cognitive impairments (“fibro fog”)
- Mood disorders such as depression and anxiety
Recent research suggests that fibromyalgia may result from central nervous system dysfunction, leading to heightened pain sensitivity. This understanding has paved the way for targeted therapies addressing the neurological underpinnings of the disease.
Emerging Treatments and Therapies
1. Tonmya (TNX-102 SL): A Promising Non-Opioid Medication
Tonmya (TNX-102 SL) is an innovative sublingual formulation of cyclobenzaprine developed by Tonix Pharmaceuticals, specifically designed for bedtime administration to treat fibromyalgia. Unlike traditional cyclobenzaprine tablets, Tonmya’s sublingual delivery allows for rapid absorption, aiming to improve sleep quality and reduce pain without the sedative hangover commonly associated with oral muscle relaxants.
In two pivotal Phase 3 clinical trials—RELIEF and RESILIENT—Tonmya demonstrated statistically significant improvements in key fibromyalgia symptoms. The RESILIENT study, completed in December 2023, showed that Tonmya significantly reduced daily pain compared to placebo (p=0.00005) and improved sleep quality, fatigue, and overall fibromyalgia impact scores.
Tonmya was generally well-tolerated, with the most common adverse event being transient oral numbness at the site of administration. No serious adverse events were reported, and the safety profile was consistent with previous studies. The FDA has accepted the New Drug Application for Tonmya, and its approval could mark the first new fibromyalgia medication in over a decade.
Experts believe that Tonmya’s targeted approach to improving non-restorative sleep—a core issue in fibromyalgia—could offer a dual benefit by alleviating pain and enhancing overall quality of life. If approved, Tonmya may become a cornerstone in fibromyalgia management, providing a non-opioid alternative for patients seeking effective symptom relief.
2. Stanza: Digital Behavioral Therapy
Stanza is a groundbreaking digital therapeutic developed by Swing Therapeutics, offering a self-guided, smartphone-based program rooted in Acceptance and Commitment Therapy (ACT). Designed to address the multifaceted symptoms of fibromyalgia, Stanza provides daily 15-minute sessions that include mindfulness exercises, journaling prompts, and educational lessons to help patients manage pain, fatigue, sleep disturbances, and emotional challenges.
In the PROSPER-FM Phase 3 clinical trial, Stanza demonstrated significant improvements across various endpoints. At week 12, 70.6% of participants reported overall improvement compared to 22.2% in the control group. Notably, Stanza users experienced reductions in pain intensity, fatigue, sleep interference, depression, and anxiety, with no treatment-related adverse events reported.
Stanza received FDA De Novo marketing authorization in 2023, making it the first digital therapeutic approved for fibromyalgia symptom management. It is currently available by prescription through Swing Care, a virtual specialty clinic focused on comprehensive fibromyalgia treatment. Patients have praised Stanza for its accessibility, ease of use, and the empowerment it provides in managing their condition.
By integrating evidence-based behavioral therapy into a convenient digital format, Stanza represents a significant advancement in non-pharmacological fibromyalgia treatment, offering patients a flexible and effective tool to improve their quality of life.
3. Cannabis Terpenes: Natural Pain Relief
Recent research has highlighted the potential of cannabis-derived terpenes as alternative treatments for fibromyalgia pain. Terpenes are aromatic compounds found in various plants, including Cannabis sativa, and are responsible for their distinct scents and flavors. Unlike THC, terpenes do not produce psychoactive effects, making them attractive candidates for pain management.
A study conducted by researchers at the University of Arizona Health Sciences tested four terpenes—geraniol, linalool, beta-caryophyllene, and alpha-humulene—in mouse models of fibromyalgia and post-surgical pain. The findings revealed that these terpenes significantly reduced pain levels, with geraniol providing the most substantial relief. The terpenes appear to exert their effects by activating the adenosine A2a receptor, which plays a role in pain modulation.
These results suggest that terpenes could offer a non-opioid, non-psychoactive alternative for managing fibromyalgia pain. Further research and clinical trials are needed to confirm their efficacy and safety in humans, but the preliminary data is promising. As the medical community continues to seek effective and safer pain management options, cannabis terpenes may emerge as valuable components in the treatment arsenal for fibromyalgia.
4. Ketamine Implants: Sustained Symptom Control
Silo Pharma has developed SP-26, an innovative ketamine implant designed to provide sustained relief for fibromyalgia symptoms. Ketamine, traditionally used as an anesthetic, has shown promise in treating chronic pain and depression at low doses. However, its short half-life and potential for abuse have limited its use.
The SP-26 implant addresses these challenges by delivering a controlled, time-released dose of ketamine directly into the body, maintaining therapeutic levels over an extended period. This method aims to reduce the frequency of dosing and minimize side effects associated with peak plasma concentrations. Silo Pharma has filed a provisional patent for this delivery system, citing positive preclinical results regarding its stability and efficacy.
While still in the developmental stage, the SP-26 implant represents a novel approach to managing fibromyalgia, particularly for patients who have not responded to conventional treatments. By providing consistent symptom control, this implant could improve patient adherence and quality of life. Clinical trials are necessary to evaluate its safety and effectiveness in humans, but the technology holds promise as a long-term solution for chronic pain management in fibromyalgia.
5. Neurofeedback Therapy
Neurofeedback therapy is an emerging non-invasive treatment that trains individuals to regulate their brain activity, potentially alleviating symptoms of fibromyalgia. This technique involves monitoring brainwaves through electroencephalography (EEG) and providing real-time feedback, enabling patients to modify dysfunctional neural patterns associated with pain perception.
A randomized placebo-controlled trial investigated the feasibility of electroencephalographic effective connectivity neurofeedback treatment for fibromyalgia. The study found that neurofeedback could modulate brain connectivity patterns associated with pain perception, offering a non-invasive treatment avenue.
By targeting the central nervous system’s role in fibromyalgia, neurofeedback therapy offers a promising avenue for symptom management. However, more extensive research is needed to establish standardized protocols and determine long-term efficacy. As our understanding of the brain’s involvement in fibromyalgia deepens, neurofeedback may become an integral component of a multidisciplinary treatment approach.
6. Oral Health and Fibromyalgia
Emerging research has identified a surprising link between oral health and fibromyalgia symptoms. A study published in Frontiers in Pain Research analyzed data from 186 women, 67% of whom had fibromyalgia, and found that those with poor dental health were significantly more likely to experience moderate to severe body pain and migraines.
The study suggests that oral microbes may interact with the nervous system, potentially contributing to the development or exacerbation of fibromyalgia symptoms. Lead author Dr. Joanna Harnett emphasized the importance of recognizing oral health as a contributing factor to chronic pain and recommends maintaining good dental hygiene habits, including brushing twice daily, flossing regularly, and annual dental visits.
These findings underscore the need for a holistic approach to fibromyalgia management, considering factors beyond traditional musculoskeletal and neurological domains. Incorporating dental evaluations and promoting oral hygiene could become essential components of comprehensive fibromyalgia care.
7. Exercise and Movement Therapies
Regular physical activity is a cornerstone in managing fibromyalgia symptoms, with low-impact exercises like Tai Chi showing particular promise. Tai Chi, a traditional Chinese martial art characterized by slow, deliberate movements and deep breathing, has been found to reduce pain, improve sleep, enhance mood, and increase overall quality of life in fibromyalgia patients.
A study published in the BMJ compared the effects of Tai Chi to aerobic exercise in fibromyalgia patients and found that Tai Chi was more effective in reducing symptoms and had higher adherence rates. Participants practicing Tai Chi reported greater improvements in pain, fatigue, and physical function, with benefits increasing over time.
The gentle nature of Tai Chi makes it accessible to individuals with varying fitness levels and can be adapted to accommodate physical limitations. Incorporating such movement therapies into daily routines can empower patients to take an active role in their symptom management, fostering a sense of control and well-being.
Integrative and Lifestyle Approaches
1. Neurofeedback Therapy
A randomized placebo-controlled trial explored the feasibility of electroencephalographic effective connectivity neurofeedback treatment for fibromyalgia. The study found that neurofeedback could modulate brain connectivity patterns associated with pain perception, offering a non-invasive treatment avenue.
2. Oral Health and Fibromyalgia
An Australian study published in Frontiers in Pain Research uncovered a significant link between poor oral hygiene and increased risk of body pain, including fibromyalgia. Women with worse dental health were 60% more likely to suffer from moderate to severe body pain. These findings highlight the importance of maintaining good oral hygiene as part of fibromyalgia management.
3. Exercise and Movement Therapies
While exercise intolerance is common in fibromyalgia, gentle physical activities like walking, yoga, or Tai Chi have been shown to improve symptoms and heart health. Gradual, consistent movement can aid recovery by reducing pain sensitivity and improving overall well-being.
Final Words:
As of 2025, fibromyalgia treatment is entering a new era—marked by innovation, personalization, and a deeper understanding of its complex origins. From groundbreaking medications like Tonmya to digital solutions like Stanza, and from ketamine implants to neurofeedback and holistic practices like Tai Chi and dental care, patients now have a broader range of options tailored to their unique needs. These advancements reflect a growing recognition that fibromyalgia requires a multidisciplinary, patient-centered approach that addresses both the physical and emotional aspects of chronic pain.
At Dao Integrated Health, we are proud to be at the forefront of fibromyalgia care. Our expert team integrates cutting-edge therapies with compassionate, whole-body care to help patients regain control over their health and quality of life. Whether you’re newly diagnosed or seeking advanced options, Dao Integrated Health provides the best fibromyalgia support—offering guidance, relief, and hope every step of the way. Contact us today!
