Sufentanil

Sufentanil is an opioid agonist. When used in balanced general anesthesia, sufentanil has been reported to be as much as 10 times as potent as fentanyl.

• Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: • as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. • as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.

• Sufentanil Citrate Injection is contraindicated in patients with: • Hypersensitivity to sufentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2) ] • Hypersensitivity to sufentanil.contraindicated

• Sufentanil Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. • Ensure that an opioid overdose reversal agent, resuscitative and intubation equipment, and oxygen are readily available. ( 2.1 ) • Individualize dosing based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved. ( 2.1 ) • Initiate analgesic treatment with 1 to 2 mcg/kg intravenously. ( 2.2 ) • Initiate epidural injection for labor and delivery at 10 to 15 mcg of Sufentanil administered with 10 mL bupivacaine 0.125% with or without epinephrine. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Sufentanil Citrate Injection should be administered only by persons specifically trained in the use of intravenous or epidural anesthetics and management of the respiratory effects of potent opioids. In patients administered high doses of Sufentanil Citrate Injection, it is essential that qualified personnel and adequate facilities are available for the management of postoperative respiratory depression. For purposes of administering small volumes of Sufentanil Citrate Injection accurately, the use of a tuberculin syringe or equivalent is recommended. • Ensure that an opioid overdose reversal agent (e.g., naloxone, nalmefene) , resuscitative and intubation equipment, and oxygen are readily available .

• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Monitor closely, particularly during initiation and titration. ( 5.2 ) • Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement : Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. ( 5.5 ) • Severe Cardiovascular Depression : Monitor during dosage initiation and titration. ( 5.6 ) • Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced ‎Hyperalgesia (OIH) occurs when an opioid analgesic ‎paradoxically causes an increase in pain, or an increase in ‎sensitivity to pain. If OIH is suspected, carefully consider appropriately ‎decreasing the dose of the current opioid analgesic, or ‎opioid rotation. ( 5.7 )‎ • Serotonin Syndrome : Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Sufentanil Citrate Injection if serotonin syndrome is suspected. ( 5.8 ) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury : Monitor for sedation and respiratory depression. ( 5.10 ) 5.1 Addiction, Abuse, and Misuse Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance. As an opioid, Sufentanil Citrate Injection exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9) ]. Opioids are sought for nonmedical use and are subject to diversion from ‎legitimate prescribed use.

The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] • Skeletal Muscle Rigidity and Skeletal Muscle Movement [see Warnings and Precautions (5.5) ] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] • Severe Cardiovascular Depression [see Warnings and Precautions (5.6) ] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ]‎ • Serotonin Syndrome [see Warnings and Precautions (5.8) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11) ] • ‎ Seizures [see Warnings and Precautions (5.12) ] Most common adverse reactions were apnea, rigidity, and bradycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Epidural Use in Labor and Delivery Epidural sufentanil was tested in 340 patients in two (one single-center and one multicenter) double-blind, parallel studies. Doses ranged from 10 to 15 mcg sufentanil and were delivered in a 10 mL volume of 0.125% bupivacaine with and without epinephrine 1:200,000.

• Pregnancy : May cause fetal harm. ( 8.1 ) • Lactation : Infants exposed to Sufentanil Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression. ( 8.2 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Sufentanil Citrate Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, embryolethality and maternal toxicity were noted in rabbits when sufentanil was administered intravenously at 0.9 times the human procedural dose of 30 mcg/kg during organogenesis. Decreased live fetuses and pup survival were noted in rats treated with sufentanil late in gestation and throughout lactation at doses below the human procedural dose. No malformations were observed in either rats or rabbits at doses below the human procedural dose [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Sufentanil Citrate Injection is administered by the intravenous or epidural route. The pharmacokinetics of intravenous sufentanil can be described as a three-compartment model.

Clinical Presentation Acute overdose with sufentanil can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures.

• Dec 11, 1996ANDAANDA074534Hospira
• Nov 2, 2018NDANDA209128Vertical Pharms

1. 1Anaphylactic Shock1,00216%
2. 2Hypotension5458.4%
3. 3Anaphylactic Reaction3074.8%
4. 4Drug Ineffective2924.5%
5. 5Tachycardia2584.0%
6. 6Cardiac Arrest2223.4%
7. 7Off Label Use2053.2%
8. 8Bronchospasm1913.0%
9. 9Drug Interaction1882.9%
10. 10Pain1642.5%
11. 11Rash1632.5%
12. 12Erythema1522.4%
13. 13Exposure During Pregnancy1462.3%
14. 14Bradycardia1352.1%
15. 15Cardio-respiratory Arrest1332.1%

Recent PubMed references pinned to Sufentanil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Oxycodone versus Sufentanil for Postoperative Analgesia and Early Recovery After Radical Gastrectomy: A Propensity Score-Matched Study.
  Drug design, development and therapy · 2026 · Wang Y, Hu L, Chen Z, et al.
  PMID 42232092DOI 10.2147/DDDT.S606394
• Effects of oxycodone and sufentanil on the quality of recovery after laparoscopic total hysterectomy: A randomized controlled trial.
  Medicine · 2026 · Liu Z, Guo S
  PMID 42216335DOI 10.1097/MD.0000000000048778
• Intranasal sufentanil versus ketamine for acute severe traumatic pain in children: protocol for a phase II randomised controlled trial (SUF-KET-PED).
  BMJ open · 2026 · Mendes Dos Reis C, Olla M, Freyssinet E, et al.
  PMID 42161544DOI 10.1136/bmjopen-2025-112617
• The Satisfactory Analgesia and Minimal Emesis of Elderly Patients After Thoracoscopic Lung Surgery: Oliceridine versus Sufentanil in a Randomized Controlled Trial.
  Drug design, development and therapy · 2026 · Cai Y, Jiang Y, Zhang Q, et al.
  PMID 42125217DOI 10.2147/DDDT.S593306
• Effects of Oliceridine versus Sufentanil on Postoperative Nausea and Vomiting in Patients Undergoing Modified Radical Mastectomy: A Double-Blind Randomized Controlled Trial.
  Drug design, development and therapy · 2026 · Lu L, Zhou Y, Xu K, et al.
  PMID 42117076DOI 10.2147/DDDT.S602305
• Feedback-Regulated versus Constant-Rate Sufentanil Patient-Controlled Analgesia for Postoperative Nausea and Vomiting After Laparoscopic Myomectomy: A Randomized Controlled Trial.
  Drug design, development and therapy · 2026 · Ma Q, Wang M, Zhang W, et al.
  PMID 42052102DOI 10.2147/DDDT.S597391
• Opioid-induced respiratory depression in cosmetic surgery: A medico-legal analysis of a fatal adverse event.
  Legal medicine (Tokyo, Japan) · 2026 · Padalino P, Cuman O, Cestonaro C, et al.
  PMID 42030896DOI 10.1016/j.legalmed.2026.102847
• A Comparison of Oliceridine versus Sufentanil for Patient-Controlled Analgesia After Total Knee Arthroplasty in Elderly Patients: A Double-Blinded Randomized Controlled Study.
  Drug design, development and therapy · 2026 · Liu X, Wang S, Chen X, et al.
  PMID 41939437DOI 10.2147/DDDT.S587944

The 10 most recently updated of 587 ClinicalTrials.gov registrations naming Sufentanil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery
  Recruiting · Interventional · 1,170 enrolled · Beijing Tiantan Hospital
  NCT07361822updated 2026-06-12
• Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.
  Terminated · Phase 3 · Interventional · 115 enrolled · University Hospital, Bordeaux
  NCT04076748updated 2026-06-11
• COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
  Recruiting · Interventional · 570 enrolled · University Hospital, Bordeaux
  NCT06425614updated 2026-06-11
• Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery
  Not yet recruiting · Phase 4 · Interventional · 84 enrolled · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  NCT07637968updated 2026-06-10
• Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery
  Completed · Phase 4 · Interventional · 96 enrolled · YanYing Xiao
  NCT07026162updated 2026-06-09
• Sufentanil Infusion vs Sufentanil Bolus
  Completed · Phase 4 · Interventional · 65 enrolled · University of Nebraska
  NCT04226495updated 2026-06-08
• Evaluation of the Efficacy of Sublingual Sufentanil (Prescribed as Rescue Analgesia for Acute Postoperative Pain) on the Quality of Health Recovery After Surgery: a Randomized, Controlled, Multicenter, Open-label Trial Against an Active Comparator (SUBLIME)
  Not yet recruiting · Phase 4 · Interventional · 1,150 enrolled · University Hospital, Strasbourg, France
  NCT07624006updated 2026-06-03
• Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients
  Not yet recruiting · Interventional · 400 enrolled · Clinical Centre of Serbia
  NCT07618130updated 2026-06-01
• Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial
  Recruiting · Interventional · 90 enrolled · Anqing Municipal Hospital
  NCT06990893updated 2026-06-01
• Intubation Conditions During ERCP With Lidocaine Aerosol Plus Low-dose Cisatracurium or Conventional-dose Cisatracurium
  Completed · Phase 4 · Interventional · 186 enrolled · Jiangang Song
  NCT07185074updated 2026-05-28

CPIC-curated drug–gene pairs for Sufentanil. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• COMTCPIC CClinPGx 3
  CYP2D6, OPRM1, COMT, and Opioids
• OPRM1CPIC CClinPGx 3
  CYP2D6, OPRM1, COMT, and Opioids

Frequently asked questions

How does Sufentanil work?

Sufentanil is an opioid agonist. When used in balanced general anesthesia, sufentanil has been reported to be as much as 10 times as potent as fentanyl.

What is Sufentanil used for?

According to FDA labeling, Sufentanil carries indications including: Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: • as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. • as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sufentanil?

Sufentanil is classified as Opioid anesthetics, Opioid Agonist, Full Opioid Agonists, Analgesia, Decreased Organized Electrical Activity.

What are the brand names for Sufentanil?

Sufentanil is marketed under brand names including Dsuvia.

What are the contraindications for Sufentanil?

Sufentanil labeling lists contraindications including: Sufentanil Citrate Injection is contraindicated in patients with: • Hypersensitivity to sufentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2) ] • Hypersensitivity to sufentanil.. Always consult the full prescribing information and a clinician.