{"id":"sufentanil-sublingual-tablet-system","safety":{"commonSideEffects":[{"rate":null,"effect":"Respiratory depression"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Sedation"},{"rate":null,"effect":"Hypotension"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Sufentanil activates mu-opioid receptors throughout the brain and spinal cord, inhibiting pain signal transmission and producing rapid onset analgesia. The sublingual tablet system allows for quick absorption through the oral mucosa, providing faster pain relief compared to oral formulations. It is approximately 5-10 times more potent than fentanyl.","oneSentence":"Sufentanil is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and sedation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:10:05.864Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute pain management in opioid-tolerant patients"},{"name":"Breakthrough pain in opioid-tolerant cancer patients"}]},"trialDetails":[{"nctId":"NCT04432428","phase":"PHASE4","title":"Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty","status":"COMPLETED","sponsor":"University Hospital, Ghent","startDate":"2020-05-26","conditions":"Postoperative Pain","enrollment":90},{"nctId":"NCT05259098","phase":"PHASE4","title":"Morphine vs Sufentanil PCA: Same Same or Different?","status":"COMPLETED","sponsor":"Hospital Central do Funchal","startDate":"2019-10-01","conditions":"Analgesia, Post Operative Pain, Patient Satisfaction","enrollment":54},{"nctId":"NCT04448457","phase":"NA","title":"Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Tivoli","startDate":"2017-09-01","conditions":"Postoperative Pain","enrollment":72},{"nctId":"NCT03036514","phase":"NA","title":"Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.","status":"COMPLETED","sponsor":"University Hospital, Antwerp","startDate":"2017-04-05","conditions":"Pain, Postoperative","enrollment":27},{"nctId":"NCT03403842","phase":"NA","title":"Acute Post-operative Pain in Colon Resections","status":"UNKNOWN","sponsor":"IRCCS San Raffaele","startDate":"2018-02-01","conditions":"Analgesia","enrollment":159},{"nctId":"NCT02662764","phase":"PHASE3","title":"Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg","status":"COMPLETED","sponsor":"Talphera, Inc","startDate":"2016-09-28","conditions":"Moderate-to-severe Acute Pain","enrollment":320}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["zalviso"],"phase":"marketed","status":"active","brandName":"Sufentanil Sublingual Tablet System","genericName":"Sufentanil Sublingual Tablet System","companyName":"Hospital Central do Funchal","companyId":"hospital-central-do-funchal","modality":"Small molecule","firstApprovalDate":"","aiSummary":"The Sufentanil Sublingual Tablet System is a small molecule that acts as a mu opioid receptor agonist, classified as an agonist. It is used to treat conditions such as analgesia, postoperative pain, moderate-to-severe acute pain, and postoperative pain.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":"2015-09-18T00:00:00.000Z","mah":"FGK Representative Service GmbH","brand_name_local":"Zalviso","application_number":"EMEA/H/C/002784"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}