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Bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg was evaluated for efficacy and safety in patients with fibromyalgia. Methods: A phase 3, double-blind, multicenter, placebo-controlled trial randomized participants 1:1 to once-nightly TNX-102 SL or matching placebo, with primary outcomes based on week 14 pain diary scores. Results: TNX-102 SL showed significantly greater reductions in primary pain and multiple secondary measures. Conclusion: Bedtime TNX-102 SL improved symptoms and function with generally good tolerability.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/pain-relief-by-targeting-nonrestorative-sleep-in-fibromyalgia-a-phase-3-randomized-trial-of-bedtime-sublingual-cyclobenzaprine/444955/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/pain-relief-by-targeting-nonrestorative-sleep-in-fibromyalgia-a-phase-3-randomized-trial-of-bedtime-sublingual-cyclobenzaprine/444955.png","ImageObject",300,407,{"name":92,"@type":93},"A glass of water","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-07","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",12,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What was the primary objective of this phase 3 trial?","Question",{"text":113,"@type":114},"To evaluate the efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg in treating fibromyalgia, focusing on pain related to nonrestorative sleep and associated symptoms.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"How was the trial designed and what was the primary endpoint?",{"text":118,"@type":114},"This double-blind, multicenter, placebo-controlled study randomized patients 1:1 to TNX-102 SL or placebo. The primary endpoint was the change from baseline at week 14 in weekly average daily diary pain intensity scores.",{"name":120,"@type":111,"acceptedAnswer":121},"What were the key safety findings and most common adverse events?",{"text":122,"@type":114},"Treatment-emergent adverse events were generally well tolerated. Common systemic events included COVID-19, headache, and somnolence, while the most frequent overall events were local oral administration-site reactions such as oral hypoesthesia, abnormal product taste, and oral paresthesia, typically transient and self-limited.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},444955,1790947398,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":44,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},962090760832,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Pain Medicine, 2026, 27, 86–94 [https://doi.org/10.1093/pm/pnaf089](https://doi.org/10.1093/pm/pnaf089)[ ](https://doi.org/10.1093/pm/pnaf089)Advance access publication 8 July 2025  \nOriginal Research Article  \nSPECIAL POPULATIONS  \nPain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine  \nSeth Lederman , MD 1, Lesley M. Arnold , MD2, Ben Vaughn , MS􀀃􀀃 ,3, Jean M. Engels , MS 1, Mary Kelley , MPH 1, Gregory M. Sullivan , MD􀀃 , 1 1Tonix Pharmaceuticals, Inc., Chatham, NJ 07928, United States  \n2 University of Cincinnati College of Medicine, Cincinnati, OH 45267, United States 3 Rho Inc., Chapel Hill, NC 27713, United States  \n􀀃 Corresponding author: Tonix Pharmaceuticals, Inc., 26 Main Street, Suite 101, Chatham, NJ 07928, United States. Email: [Greg.Sullivan@TonixPharma.com](Greg.Sullivan@TonixPharma.com)[ ](Greg.Sullivan@TonixPharma.com)􀀃􀀃 Ben Vaughn was affiliated with Rho Inc. at the time the study was conducted.  \nAbstract  \nObjective: Fibromyalgia 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.  \nMethods: This 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.  \nResults: Overall, 81.0%(n ¼ 187/231) and 79.6%(n ¼ 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 \u003C .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.  \nConclusion: Bedtime TNX-102 SL treatment was associated with significant improvements in fibromyalgia symptoms and function and was well tolerated.  \n[Clinical trial registration:](Clinical trial registration: ClinicalTrials.gov/study/NCT05273749)[ ClinicalTrials.gov/study/NCT05273749](Clinical trial registration: ClinicalTrials.gov/study/NCT05273749), first patient screened March 21, 2022.  \nKeywords: fibromyalgia; cyclobenzaprine; nociplastic pain; sleep; clinical trial  \nLay Summary  \nBedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg was associated with significant improvements versus placebo in core fibromyalgia symptoms of widespread pain, disrupted sleep, and fatigue in a double-blind, randomized, placebo-controlled phase 3 study. TNX-102 SL was generally safe and well tolerated, with the most common treatment-emergent adverse events being oral administration–site related that were typically mild, transient, and self-limited. Results validate findings from a previous phase 3 trial that demonstrated efficacy in reducing pain.  \nIntroduction  \nFibromyalgia is a common, chronic pain syndrome characterized by widespread pain, nonrestorative sleep, and fatigue.1 Fibromyalgia affects 􀀘 6.4% of adults, predominantly women, in the United States.2 Poor sleep quality h","cbCaijADxMViEOCJ","https://ap.wps.com/l/cbCaijADxMViEOCJ","pdf",2485544,"English","# Abstract\n## Objective\n## Methods\n## Results\n## Conclusion\n# Introduction\n# Trial Outcomes\n## Primary endpoint\n## Secondary endpoints\n## Adverse events\n# Lay Summary","[{\"question\":\"What was the primary objective of this phase 3 trial?\",\"answer\":\"To evaluate the efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg in treating fibromyalgia, focusing on pain related to nonrestorative sleep and associated symptoms.\"},{\"question\":\"How was the trial designed and what was the primary endpoint?\",\"answer\":\"This double-blind, multicenter, placebo-controlled study randomized patients 1:1 to TNX-102 SL or placebo. The primary endpoint was the change from baseline at week 14 in weekly average daily diary pain intensity scores.\"},{\"question\":\"What were the key safety findings and most common adverse events?\",\"answer\":\"Treatment-emergent adverse events were generally well tolerated. Common systemic events included COVID-19, headache, and somnolence, while the most frequent overall events were local oral administration-site reactions such as oral hypoesthesia, abnormal product taste, and oral paresthesia, typically transient and self-limited.\"}]","Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine | PDF",1790709890,23]