Fibromyalgia: A Comprehensive Update for 2026 - Current Perspectives on Pathophysiology, Diagnosis, and Management

Author: Dr Debjyoti Dutta & Dr Chinmoy Roy, Asian Pain Academy

ABSTRACT - Fibromyalgia (FM) is a chronic pain syndrome characterised by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive dysfunction. It affects an estimated 2–8% of the global population, with a marked female preponderance. Despite decades of research, the exact pathophysiology remains incompletely understood, though central sensitisation and neurotransmitter dysregulation are now recognised as central mechanisms. In the Indian context, fibromyalgia continues to be underdiagnosed and mismanaged, with significant diagnostic delays reported in recent hospital-based studies. The year 2025 witnessed a landmark development with the United States Food and Drug Administration (FDA) approval of sublingual cyclobenzaprine (Tonmya™), the first new drug approved for fibromyalgia in over 15 years, bringing the total number of FDA-approved agents to four. Recent evidence has further strengthened the role of non-pharmacological interventions, particularly aerobic exercise, cognitive behavioural therapy (CBT), and patient education, as first-line management strategies. Emerging areas such as neuroinflammation, gut microbiota alterations, immune dysregulation, digital therapeutics, and neuromodulation techniques are opening new avenues for both understanding and managing this complex condition. This review provides a comprehensive and updated overview of the current understanding, diagnostic approaches, and therapeutic strategies for fibromyalgia, with attention to the Indian clinical perspective.

Keywords: Fibromyalgia, central sensitisation, chronic pain, Tonmya, cyclobenzaprine, pregabalin, duloxetine, cognitive behavioural therapy, nociplastic pain, neuroinflammation

INTRODUCTION - Fibromyalgia Update for 2026

Fibromyalgia (FM) is one of the most common chronic pain syndromes encountered in clinical practice across the world. Characterised by widespread musculoskeletal pain that persists for at least three months, it is frequently accompanied by a constellation of other distressing symptoms, including fatigue, unrefreshing sleep, cognitive difficulties (often referred to as “fibro fog”), headaches, and mood disturbances.^1,2 The condition exerts a substantial burden on patients, their families, and healthcare systems alike. Despite growing recognition within the medical community, fibromyalgia remains a diagnosis that is frequently missed, delayed, or dismissed, especially in resource-limited settings such as India.

The global prevalence of FM is estimated to range between 2% and 8%, though this varies considerably depending on the geographical region, the population studied, and the diagnostic criteria applied.^3,4 Women are disproportionately affected, with the female-to-male ratio ranging from 2:1 to as high as 9:1 in some studies.⁵ In India, although community-level data remain limited, a recent five-year hospital-based study from Northeast India (2025) reported that 13.9% of all neurology outpatients met the ACR 2016 criteria for fibromyalgia, with 90.9% of the diagnosed patients being female and the average diagnostic delay exceeding 3.5 years.⁶ These figures underscore the urgent need for increased awareness and education about FM amongst primary care physicians and specialists in our country.

Over the past year, several significant developments have taken place in the field of fibromyalgia. These include the approval of a new medication, advances in our understanding of the neurobiological underpinnings of the disease, and growing evidence supporting the central role of non-pharmacological therapies. This review aims to provide a comprehensive update on these developments for the practising clinician.

EVOLVING UNDERSTANDING OF PATHOPHYSIOLOGY

Central Sensitisation and Nociplastic Pain

The prevailing understanding of fibromyalgia pathophysiology centres on the concept of central sensitisation—an augmented responsiveness of central neurons in the spinal cord and brain to normal or even subthreshold sensory inputs.^7,8 The International Association for the Study of Pain (IASP) now classifies fibromyalgia pain as “nociplastic”—a term that describes pain arising from altered nociceptive processing in the central nervous system, without evidence of actual tissue damage or somatosensory nerve lesion.⁹ This conceptual shift has been important in legitimising the condition and moving the discourse away from the outdated view that FM is purely psychogenic.

Functional neuroimaging studies continue to reveal altered brain connectivity patterns in FM patients. Research published in 2024 and 2025 has demonstrated that patients with fibromyalgia show disrupted resting-state functional connectivity of the periaqueductal grey matter, which impairs the descending pain inhibitory pathways.¹⁰ Additionally, abnormal connectivity between the default mode network and key pain-processing regions, such as the insula, has been observed, with such changes correlating with symptom duration and severity.¹⁰ Evidence from spinal cord studies has also pointed towards imbalanced activity between the ventral and dorsal cervical spinal cord, suggesting that central sensitisation mechanisms operate at multiple levels of the neuraxis.¹⁰

Neuroinflammation and Immune Dysregulation

A growing body of evidence now implicates neuroinflammation as a key contributor to FM pathophysiology. Activation of microglial cells in the brain and the subsequent release of pro-inflammatory cytokines, including interleukin-6 (IL-6), interleukin-8 (IL-8), and tumour necrosis factor-alpha (TNF-α), have been demonstrated in FM patients using advanced positron emission tomography (PET) imaging techniques.^11,12 A comprehensive review published in 2025 in Exploration of Immunology highlighted that FM patients exhibit elevated levels of these pro-inflammatory cytokines alongside reduced levels of anti-inflammatory mediators such as IL-10, thereby perpetuating a chronic pro-inflammatory state.¹² Furthermore, alterations in regulatory T-cell counts and reduced natural killer (NK) cell activity have been reported, suggesting a broader immune dysregulation in this condition.¹²

Small Fibre Pathology

The recognition that a substantial proportion of FM patients demonstrate evidence of small fibre pathology has added another dimension to our understanding of this condition. A 2025 systematic review and meta-analysis by Nejad and colleagues found that approximately 49% of FM patients exhibited evidence of small fibre neuropathy, based on pooled data from skin biopsy and corneal confocal microscopy studies.¹³ This finding is clinically relevant because it suggests that peripheral nociceptive input may serve as a driver that initiates or sustains the central sensitisation process. It also raises the possibility that FM, at least in a subset of patients, may have a demonstrable structural neuropathological basis.

The Gut–Brain Axis and Microbiome

An exciting and rapidly evolving area of research concerns the role of the gut microbiota in fibromyalgia. A year-in-review article published by Iannuccelli and colleagues (2025) in Clinical and Experimental Rheumatology noted that alterations in gut microbial composition have been consistently observed in FM patients and may contribute to both immune dysregulation and emotional disturbances.¹⁴ These findings are in line with the broader understanding of the gut–brain axis and its influence on chronic pain states. While therapeutic manipulation of the gut microbiome (through probiotics, dietary modifications, or faecal microbiota transplantation) remains largely investigational, it represents a promising future direction.

Fibromyalgia and Long COVID: An Emerging Overlap - Fibromyalgia Update for 2026

The COVID-19 pandemic has brought renewed attention to the overlap between fibromyalgia and post-viral syndromes. An expert review published in 2025 explored the shared pathophysiological features of Long COVID, fibromyalgia, and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), proposing central sensitisation as a unifying framework.¹⁵ A separate comprehensive scoping review on MedRxiv (2025) further documented that many individuals with non-hospitalised COVID-19 developed new-onset fibromyalgia-type symptoms, including widespread pain, cognitive dysfunction, and fatigue, suggesting that viral infections may serve as potent triggers for central sensitisation in genetically or immunologically predisposed individuals.¹⁶ This overlap has important implications for Indian clinicians, who are likely to encounter patients presenting with post-COVID chronic pain syndromes that closely mimic or indeed fulfil criteria for FM.

DIAGNOSTIC CONSIDERATIONS IN 2026

The diagnostic approach to fibromyalgia has undergone considerable evolution over the past three decades. The original 1990 ACR criteria, which relied on the identification of at least 11 out of 18 tender points on physical examination, proved difficult to standardise in routine clinical practice and were criticised for their failure to capture the full breadth of FM symptomatology.¹⁷ The revised 2010/2011 ACR criteria, and their subsequent 2016 modification, moved away from tender point counts and instead adopted a symptom-based approach using the Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS).¹⁸ These newer criteria require the presence of generalised pain in at least four of five body regions and a combined WPI and SSS score meeting defined thresholds, thereby reducing the risk of misclassifying regional pain syndromes as fibromyalgia.

The 2016 criteria have also narrowed, though not eliminated, the observed sex disparity in FM diagnosis. Research from 2025 suggests that FM in men may continue to be under-recognised in clinical practice, partly because of prevailing gender biases and partly because men may present with different symptom profiles.¹⁹ A patient-oriented guideline published in the Journal of Evidence-Based Medicine (2025 Edition) strongly emphasised that early consultation with a rheumatologist or pain specialist, along with clear communication of symptoms, is essential for timely and accurate diagnosis.²⁰

Summary of the ACR 2016 Diagnostic Criteria

Criterion	Requirement
Pain Distribution	Widespread pain in at least 4 of 5 body regions (excluding jaw, chest, and abdomen from the generalised pain criterion)
WPI Score	Widespread Pain Index ≥ 7 and SSS ≥ 5; OR WPI 4–6 and SSS ≥ 9
Duration	Symptoms present at a similar level for at least 3 months
Exclusion	A diagnosis of FM is valid irrespective of other diagnoses. It does not exclude or is excluded by other clinical conditions
No Longer Required	Tender point examination is not required

WPI: Widespread Pain Index; SSS: Symptom Severity Scale; ACR: American College of Rheumatology. Adapted from Wolfe et al., 2016.

MANAGEMENT: THE MULTIMODAL IMPERATIVE

The management of fibromyalgia remains challenging and, by consensus across all major international guidelines, requires a multimodal and individualised approach that combines both non-pharmacological and pharmacological strategies.^21,22,23 No single intervention is capable of addressing all the symptoms of FM, and patient expectations must be managed realistically. The goal of treatment is not “cure” but rather meaningful improvement in symptoms, functional capacity, and quality of life.

Patient Education: The Foundation

Patient education is universally recommended as the very first step in the management of fibromyalgia.^21,24 A well-informed patient is more likely to adhere to treatment recommendations, engage in self-management, and cope better with the chronicity of the condition. Education should involve validating the patient’s experience (reassuring them that fibromyalgia is a real and recognised medical condition), explaining the concept of central sensitisation in simple terms, and setting realistic expectations regarding treatment outcomes. In the Indian clinical context, where awareness of FM is limited amongst both patients and many practitioners, the role of structured education programmes cannot be overemphasised. The recently published WHO-guided Patient Version of the Fibromyalgia Guideline (2025 Edition) provides a practical, evidence-based tool for this purpose.²⁰

Non-Pharmacological Interventions

All major international guidelines—including those from the European Alliance of Associations for Rheumatology (EULAR), the German AWMF guidelines, the Canadian Pain Society, and the recently published Chinese guidelines on non-pharmacological therapies (2025)—position non-pharmacological interventions as the cornerstone of FM management, to be initiated before or alongside pharmacotherapy.^21,22,25

Exercise: Exercise therapy has the strongest and most consistent evidence base among all FM treatments. A large meta-analysis of 167 randomised controlled trials (n = 11,012) found that all forms of exercise—aerobic, strengthening, aquatic, and mind-body exercises such as Tai Chi and Yoga—produced clinically meaningful improvements in pain, depression, sleep quality, and overall function.²⁶ Aerobic exercise and resistance training receive the strongest recommendations across guidelines. The 2025 Chinese guideline specifically noted that Tai Chi improved function and reduced depression in FM patients.²⁵ The key clinical message is that exercise should be prescribed in a graded and supervised fashion, starting at low intensity and progressing gradually, so as to avoid symptom flares and promote long-term adherence.

Cognitive Behavioural Therapy (CBT): CBT is the most extensively studied psychological intervention for fibromyalgia and is recommended by all major guidelines.^21,25,26 It has demonstrated efficacy in reducing pain intensity, improving sleep quality, alleviating depression and anxiety, and modifying catastrophising attitudes. A dose–response relationship has been observed, with higher doses of psychological therapy producing greater reductions in pain and depression scores.²⁴ An economic evaluation conducted alongside a six-month randomised trial found CBT to be the most cost-effective treatment option for adult FM patients when compared with pharmacotherapy and usual care.²⁷ The 2025 Italian Neurological Society consensus statement also highlighted emerging evidence that CBT can produce measurable changes in brain connectivity patterns, though this evidence remains preliminary.²⁸

Mindfulness-Based Interventions and Other Approaches: Mindfulness-based stress reduction (MBSR) and acceptance and commitment therapy (ACT) have gained increasing traction in FM management, with moderate-quality evidence supporting their benefits for pain, emotional distress, and sleep.²⁵ Other non-pharmacological modalities that have shown varying degrees of promise include acupuncture, balneotherapy, massage therapy, and meditative movement therapies. Emerging modalities such as transcranial magnetic stimulation (TMS), virtual reality-based therapy (VRBT), and digital health applications are under active investigation and may offer new options in the near future.^25,29

Pharmacological Management

Pharmacological treatment of FM should be considered as an adjunct to, and not a replacement for, non-pharmacological strategies. The current pharmacological armamentarium is detailed below.

FDA-Approved Medications for Fibromyalgia (as of 2026)

Drug	Class	Mechanism	Year Approved	Key Adverse Effects
Pregabalin (Lyrica)	Anticonvulsant	α2δ calcium channel ligand	2007	Dizziness, somnolence, weight gain, peripheral oedema
Duloxetine (Cymbalta)	SNRI	Serotonin and noradrenaline reuptake inhibition	2008	Nausea, dry mouth, constipation, dizziness
Milnacipran (Savella)	SNRI	Serotonin and noradrenaline reuptake inhibition	2009	Nausea, headache, constipation, tachycardia
Cyclobenzaprine SL (Tonmya)	Muscle relaxant (SL formulation)	Blocks 5-HT2A, H1, and muscarinic receptors	2025	Oral numbness/discomfort, somnolence, dizziness

SNRI: Serotonin and Noradrenaline Reuptake Inhibitor; SL: Sublingual; 5-HT2A: Serotonin type 2A receptor; H1: Histamine type 1 receptor.

Tonmya (Sublingual Cyclobenzaprine): The New Entrant

The most significant pharmacological development of the past year has been the FDA approval of sublingual cyclobenzaprine hydrochloride (TNX-102 SL, marketed as Tonmya™ by Tonix Pharmaceuticals) in August 2025 for the treatment of fibromyalgia in adults.³⁰ This represents the first new medication approved for FM in over 15 years and brings the total count of FDA-approved drugs for this condition to four. Cyclobenzaprine is a tricyclic compound that has been available in oral tablet form for decades as a muscle relaxant. However, the oral formulation was limited by significant first-pass hepatic metabolism and next-day sedation. The sublingual formulation bypasses first-pass metabolism, allowing rapid absorption through the oral mucosa and lower effective doses.

The approval was based on the results of three pivotal Phase 3 randomised, double-blind, placebo-controlled trials (RELIEF, RESILIENT, and RALLY), which collectively demonstrated that Tonmya 5.6 mg taken at bedtime produced significant reductions in daily pain scores over 14 weeks compared with placebo.^30,31 Improvements were also observed in the Fibromyalgia Impact Questionnaire scores, suggesting benefits beyond pain relief alone. The drug was granted Fast Track designation by the FDA, reflecting the unmet therapeutic need in this area. The most commonly reported adverse effects in the clinical trials included numbness or discomfort at the oral application site, somnolence, and dizziness, but the overall safety profile was considered acceptable. Tonmya is expected to retain market exclusivity in the United States until at least 2034.³⁰

Other Pharmacological Agents and Off-Label Use

Amitriptyline, a low-cost tricyclic antidepressant widely available across India, continues to be recommended by all major clinical practice guidelines for FM despite the lack of formal FDA approval for this indication.^21,22,23 It is particularly useful for patients in whom pain is accompanied by prominent sleep disturbance. Gabapentin, another gabapentinoid, is sometimes used off-label as an alternative to pregabalin. The 2026 Brazilian Society of Rheumatology consensus guideline emphasised a multimodal pharmacological approach tailored to each patient’s predominant symptom cluster, with careful attention to comorbidities and potential adverse effects.²³

Several other agents have been investigated for FM but remain either investigational or limited by safety concerns. These include NMDA receptor antagonists (e.g., low-dose ketamine and memantine), cannabinoids, sodium oxybate, and low-dose naltrexone.¹⁹ Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and celecoxib are explicitly not recommended as monotherapy or combination therapy for FM by the 2025 Patient Guideline, given their lack of efficacy in this centrally mediated pain condition.²⁰ Opioid analgesics are also strongly discouraged due to the risk of dependence, hyperalgesia, and lack of demonstrated benefit in FM.²¹

EMERGING THERAPEUTIC FRONTIERS

Neuromodulation

Non-invasive brain stimulation techniques, particularly transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), have garnered increasing interest for FM. A 2025 review published in Frontiers in Pain Research found that tDCS applied over the primary motor cortex produced significant pain reduction, with effects accumulating over repeated sessions—Brietzke and colleagues reported nearly 50% pain reduction after 20 sessions and up to 60% after 60 sessions.²⁹ Improvements in mood were linked to increased serum beta-endorphin levels, suggesting engagement of the endogenous opioid system. Although these results are encouraging, the variability in stimulation protocols, outcome measures, and follow-up durations across studies currently limits the formulation of definitive clinical recommendations.

Digital Therapeutics

The COVID-19 pandemic accelerated the adoption of digital health interventions for chronic pain conditions, including fibromyalgia. A 2025 review in Zeitschrift für Rheumatologie discussed the growing availability of digital apps for FM that incorporate psychoeducational content, CBT modules, and mindfulness exercises.³² The integration of artificial intelligence (AI)-powered chatbots and wearable devices for symptom tracking represents an evolving frontier. Machine learning algorithms are also being explored to identify distinct FM phenotypes, which could support the development of personalised treatment pathways. While the clinical evidence for digital therapeutics in FM is still maturing, these tools hold particular promise for improving access to evidence-based care in settings where specialist services are limited—a situation that is highly relevant to much of India.

THE INDIAN PERSPECTIVE

Fibromyalgia presents unique challenges in the Indian healthcare landscape. Awareness of the condition remains limited amongst both the general public and a significant proportion of healthcare providers. Patients often undergo prolonged and costly diagnostic odysseys, consulting multiple specialists (internists, orthopaedic surgeons, neurologists, and psychiatrists) before a correct diagnosis is made. The recent study from Northeast India by Sharma and colleagues (2025) documented that 59% of FM patients in their cohort experienced a diagnostic delay exceeding two years, with patients having consulted multiple specialists and undergone extensive unnecessary investigations prior to diagnosis.⁶ The predominance of FM amongst homemakers and individuals engaged in physically demanding occupations, as observed in this study, is a finding of considerable socioeconomic relevance.

Several factors contribute to the underdiagnosis of FM in India. These include the absence of any specific laboratory or imaging biomarker, the overlap of FM symptoms with those of common conditions such as hypothyroidism, vitamin D deficiency, and inflammatory arthritis, and a lingering scepticism about the validity of FM as a diagnosis amongst certain sections of the medical profession. Addressing these barriers will require a concerted effort towards medical education, the development of locally relevant clinical practice guidelines, and research that characterises the epidemiology and clinical profile of FM in diverse Indian populations.

From a therapeutic standpoint, the availability and affordability of medications like amitriptyline and gabapentin make them attractive first-line pharmacological options in the Indian setting. The newer FDA-approved agents, including pregabalin and duloxetine, are also widely accessible in India, though cost considerations may influence prescribing decisions. The incorporation of structured exercise programmes, yoga (which has emerging evidence for benefit in FM), and culturally adapted psychological interventions into routine clinical care represents a critical area for development.

CONCLUSION

Fibromyalgia Update for 2026 - Fibromyalgia, once dismissed as a condition of uncertain validity, is now firmly recognised as a disorder rooted in altered central pain processing and neurotransmitter dysregulation, with contributions from neuroinflammation, immune dysfunction, small fibre pathology, and possibly the gut microbiome. The diagnostic approach has been simplified and made more clinically applicable through the ACR 2016 criteria. The therapeutic landscape has been enriched by the approval of sublingual cyclobenzaprine, the continued strengthening of evidence for exercise and CBT as first-line therapies, and the emergence of promising newer modalities such as neuromodulation and digital health interventions. For the Indian clinician, the key messages are clear: maintain a high index of suspicion for FM, especially in patients presenting with chronic widespread pain and associated somatic symptoms; adopt a multimodal management strategy that begins with patient education and non-pharmacological interventions; use pharmacotherapy judiciously and in a tailored manner; and remain abreast of the rapidly evolving evidence base in this field.

Conflicts of Interest: None declared.

Funding: None.

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