SynthesisClinical rheumatology2026
Short-term efficacy and safety of sublingual cyclobenzaprine for fibromyalgia: A systematic review and meta-analysis.
Synthesis in Clinical rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Sublingual Cyclobenzaprine for Fibromyalgia: Pharmacokinetic Rationale, Clinical Evidence, and Place in Therapy.Current pain and headache reports · 2026Review
- Current evidence on TNX-102 SL (cyclobenzaprine HCl sublingual) for fibromyalgia: strengths, limitations, and emerging hypotheses.Clinical rheumatology · 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFibromyalgia (FM) is a chronic nociplastic pain syndrome marked by widespread pain, nonrestorative sleep, fatigue, and functional impairment. TNX-102 SL (cyclobenzaprine HCl sublingual) is a once-nightly, non-opioid therapy designed to improve sleep and reduce multi-domain FM symptoms.
methodsWe identified randomised, double-blind, placebo-controlled trials of TNX-102 SL in adults with FM. Outcomes included the weekly average daily pain, achieving ≥ 30% and ≥ 50% pain reduction, Patient Global Impression of Change, Fibromyalgia Impact Questionnaire-Revised (FIQ-R), and safety. Random-effects meta-analyses were performed with risk of bias assessed by RoB 2.
resultsAcross four trials (total n = 1,684), TNX-102 SL significantly increased ≥ 30% pain responders (RR 1.44; 95% CI 1.15-1.81; I
conclusionsThis meta-analysis of TNX-102 SL for fibromyalgia found that once-nightly sublingual cyclobenzaprine produced consistent improvements in pain response and global impression compared to placebo, with a good tolerability profile. TNX-102 SL represents an essential new non-opioid option for fibromyalgia. Key Points • In a meta-analysis of four randomized, double-blind trials (n = 1,684), TNX-102 SL increased ≥ 30% and ≥ 50% pain responder rates versus placebo (RR 1.44 and 1.43; low heterogeneity). • TNX-102 SL improved Patient Global Impression of Change (RR 1.52), while FIQ-R scores -were not significantly different from placebo. • Treatment-emergent adverse events were more frequent and primarily transient oral effects (hypoesthesia, paresthesia, dysgeusia), with similar discontinuation rates and no reportd deaths.
Indexed as
Identifiers
41318845What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.