Sufentanil

What it is and how it works

Mechanism of Action 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. When administered intravenously as a primary anesthetic agent with 100% oxygen, sufentanil is approximately 5 to 7 times as potent as fentanyl.

Indications

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 indicated for epidural administration: • as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery. Sufentanil Citrate Injection is an opioid agonist indicated: • as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.

Dosage and administration (summary)

• 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. • 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. • Initiate analgesic treatment with 1 to 2 mcg/kg intravenously.

Contraindications

Sufentanil Citrate Injection is contraindicated in patients with: • Hypersensitivity to sufentanil (e.g., anaphylaxis) • Hypersensitivity to sufentanil.

Warnings and precautions

• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Monitor closely, particularly during initiation and titration. • 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. • Severe Cardiovascular Depression : Monitor during dosage initiation and titration.

Pregnancy

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.

Storage and supply

Protect from light. Retain in carton until time of use. Store at 20°C to 25°C (68°F to 77°F).

Source: Sufentanil Citrate (Sufentanil Citrate) — US FDA prescribing information, 2026-06-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.