Trial reportPain medicine (Malden, Mass.)2026
Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine.
Trial report in Pain medicine (Malden, Mass.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05273749 (A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia), which is not on this map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
Who cites it
8 citing papers in PubMed.
- Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial.Clinical pharmacology in drug development · 2026Trial
- Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers.Clinical pharmacology in drug development · 2026Trial
- Sublingual Cyclobenzaprine for Fibromyalgia: Pharmacokinetic Rationale, Clinical Evidence, and Place in Therapy.Current pain and headache reports · 2026Review
- Evolving Concepts in the Diagnosis and Management of Fibromyalgia: A Moving Target.Journal of pain research · 2026Review
- The Gür fibromyalgia model: a clinically operational framework for phenotype-informed, sequence-sensitive multimodal care.Frontiers in pain research (Lausanne, Switzerland) · 2026Article
- Efficacy and Safety of Pregabalin-Tizanidine vs Pregabalin in Patients with Fibromyalgia: Study Protocol for a Multicenter, Prospective, Randomized, Controlled, Open-Label, Blinded Endpoint Trial.Journal of pain research · 2026Article
- The treatment landscape in axial spondyloarthritis-do we need new therapies?EULAR rheumatology open · 2025Review
- Gulf War Illness, Fibromyalgia, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Long COVID Overlap in Common Symptoms and Underlying Biological Mechanisms: Implications for Future Therapeutic Strategies.International journal of molecular sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectiveFibromyalgia is the prototypic nociplastic chronic pain syndrome, characterized by widespread pain, nonrestorative sleep, and fatigue. We evaluated efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg for treatment of fibromyalgia.
methodsThis phase 3, double-blind, multicenter, placebo-controlled trial randomized patients 1:1 to once-nightly TNX-102 SL 2.8 mg for 2 weeks, followed by 5.6 mg for 12 weeks, or to matching placebo (NCT05273749). The primary endpoint was change from baseline at week 14 in weekly average of daily diary pain intensity scores. Secondary endpoints included Patient Global Impression of Change, Fibromyalgia Impact Questionnaire (Revised) Symptoms and Function domains, Patient-Reported Outcomes Measurement Information System instruments for Sleep Disturbance and Fatigue, and daily diary sleep quality scores.
resultsOverall, 81.0% (n = 187/231) and 79.6% (n = 179/225) of patients receiving TNX-102 SL and placebo completed the trial, respectively. Treatment with TNX-102 SL vs placebo was associated with significantly greater reductions in the primary pain endpoint (P < .001; mean [SE], -1.8 [0.12] vs -1.2 [0.12]) and in each of the 6 secondary endpoints (P ≤ .001; all). The most common systemic treatment-emergent adverse events (TEAEs) with TNX-102 SL and placebo were COVID-19 (4.3% vs 3.1%, respectively), headache (3.0% vs 1.8%), and somnolence (3.0% vs 1.3%); the most common TEAEs overall were local administration-site reactions including oral hypoesthesia (23.4% vs 0.4%), product taste abnormal (11.3% vs 0.9%), and oral paresthesia (6.9% vs 0.9%), which were transient and self-limited.
conclusionBedtime TNX-102 SL treatment was associated with significant improvements in fibromyalgia symptoms and function and was well tolerated. CLINICAL
trial registrationClinicalTrials.gov/study/NCT05273749, first patient screened March 21, 2022.
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