Last reviewed 2026-05-27 · How we verify

Sufentanil Sublingual Tablet

Sufentanil Sublingual Tablet is a Opioid analgesic Small molecule drug developed by Centre Hospitalier Universitaire de Tivoli. It is currently FDA-approved for Acute pain management in opioid-tolerant patients, Breakthrough pain in cancer patients. Also known as: Zalviso.

Sufentanil is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and sedation.

Sufentanil Sublingual Tablet is a small molecule that acts as a mu opioid receptor agonist, classified as an agonist drug. It is used to treat conditions such as analgesia, postoperative pain, moderate-to-severe acute pain, and postoperative pain, as studied in clinical trials.

At a glance

Mechanism of action

Sufentanil activates mu-opioid receptors throughout the brain and spinal cord, inhibiting pain signal transmission and producing rapid onset analgesia. The sublingual tablet formulation allows for quick absorption through the oral mucosa, providing faster pain relief compared to oral administration. It is approximately 500-1000 times more potent than morphine.

Approved indications

• Acute pain management in opioid-tolerant patients
• Breakthrough pain in cancer patients

Common side effects

• Respiratory depression
• Dizziness
• Nausea
• Constipation
• Sedation
• Headache

Key clinical trials

• Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil (PHASE1, PHASE2)
• DSUVIA Early Evaluation of Pain Trial (PHASE3)
• Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation. (PHASE3)
• The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients (PHASE4)
• Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery (PHASE4)
• Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty (PHASE4)
• Morphine vs Sufentanil PCA: Same Same or Different? (PHASE4)
• Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty (NA)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Sufentanil Sublingual Tablet CI brief — competitive landscape report
• Sufentanil Sublingual Tablet updates RSS · CI watch RSS
• Centre Hospitalier Universitaire de Tivoli portfolio CI

Frequently asked questions about Sufentanil Sublingual Tablet

Related

• Drug class: All Opioid analgesic drugs
• Target: All drugs targeting Mu-opioid receptor (μ-OR)
• Manufacturer: Centre Hospitalier Universitaire de Tivoli — full pipeline
• Therapeutic area: All drugs in Pain Management
• Indication: Drugs for Acute pain management in opioid-tolerant patients
• Indication: Drugs for Breakthrough pain in cancer patients
• Also known as: Zalviso

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing