Sufentanil

Pronunciation: soo-FEN-ta-nil.

Generic name
sufentanil (as sufentanil citrate)
Drug class
Opioid agonist (synthetic phenylpiperidine derivative, fentanyl analogue); Schedule II / Controlled Drug
Form
Injection solution (50 mcg/mL) for IV/epidural use; single-dose 30 mcg sublingual tablet (DSUVIA/Dzuveo) delivered via a pre-filled applicator
Route
Intravenous injection, epidural injection, or sublingual (under-the-tongue) tablet, depending on the product
Legal status
Prescription-only, controlled substance, administered only by a healthcare professional in a hospital or certified medical setting

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada

Australia: · Full directory

What sufentanil (as sufentanil citrate) is and how it works

Sufentanil is an extremely potent synthetic opioid pain medicine, roughly 5-10 times more potent than fentanyl and 500-1,000 times more potent than morphine. It is used in two very different ways: as an injectable medicine given as part of anesthesia during major surgery or as pain relief during labor and delivery, or as a single-use 30 mcg sublingual (under-the-tongue) tablet for short-term treatment of acute pain in a hospital, surgical center, or emergency department. (1) (2)

Sufentanil is never self-administered by a patient at home. Both the injectable and the sublingual tablet forms are given only by a healthcare professional, in a setting equipped and staffed to manage breathing problems if they occur. Because of its potency, real risks of addiction, life-threatening breathing problems, and (for the tablet) danger from accidental exposure by anyone else who might come into contact with it, sufentanil is tightly controlled and only used under direct medical supervision.

Mechanism of action: how sufentanil (as sufentanil citrate) works

Sufentanil is a synthetic opioid agonist acting primarily at mu-opioid receptors, structurally related to fentanyl but substantially more potent and lipophilic, giving it rapid onset and short context-sensitive duration suited to anesthesia and short-term acute-pain use. (1) (2) (6)

What sufentanil (as sufentanil citrate) is used for

Anesthesia adjunct or primary anesthetic during surgery

The injectable form is used as an additional pain-control medicine alongside general anesthesia in patients who are intubated and on a ventilator, or as the main anesthetic (with 100% oxygen) for major surgery, including heart surgery and neurosurgery. (1)

Pain relief during labor and delivery

The injectable form is used, combined with a low dose of the local anesthetic bupivacaine, as an epidural injection for pain relief during labor and vaginal delivery. (1)

Short-term acute pain in a hospital or certified healthcare setting

The sublingual tablet form (DSUVIA/Dzuveo) is used for adults with acute pain severe enough to need an opioid medicine, when other treatments are not adequate, only within a hospital, surgical center, or emergency department, for a maximum of 48-72 hours depending on the country's label. (2) (3)

Before taking sufentanil (as sufentanil citrate)

Do not take / not appropriate for

  • Sufentanil should not be given to anyone with a known serious allergic reaction to sufentanil or (for the tablet) its other ingredients. (all countries) (1) (3)
  • The sublingual tablet should not be used in anyone with significant breathing problems (respiratory depression), severe or acute asthma without monitoring and resuscitation equipment available, or a known or suspected bowel obstruction (including paralytic ileus). (all countries) (2) (3)
  • Sufentanil is never taken home or used outside of a hospital, surgical center, emergency department, or other setting equipped and staffed for its use. (all countries) (2)

Tell your clinician about

  • Any personal or family history of substance use disorder, opioid misuse, or addiction.
  • Any history of breathing problems, asthma, sleep apnea, or other lung disease.
  • Any history of head injury, increased pressure in the brain, or impaired consciousness.
  • All other medicines being taken, especially benzodiazepines, sedatives, other opioids, medicines affecting liver enzymes (CYP3A4), or anything with serotonergic effects (e.g. certain antidepressants).
  • Whether you are pregnant, plan to become pregnant, or are breastfeeding, and whether delivery is expected soon (because of the risk of neonatal opioid withdrawal and respiratory depression in the newborn).
  • Any liver problems, since sufentanil is processed by the liver and dosing may need to be adjusted.
(1) (2) (3)

How to take sufentanil (as sufentanil citrate)

  • Sufentanil is never self-administered. The injectable form is given directly into a vein or into the epidural space by an anesthesia clinician; the sublingual tablet is placed under the tongue by a healthcare professional using a single-dose applicator.
  • For the sublingual tablet: it must be allowed to dissolve completely under the tongue and must not be chewed or swallowed; the patient should not eat, drink, or talk for about 10 minutes afterward.
  • The sublingual tablet is only given in a hospital, surgical center, or emergency department, and treatment must stop before the patient is discharged from that setting.
  • Dosing and timing are set and adjusted entirely by the treating clinician, based on the specific procedure, the patient's response, and continuous monitoring.
(1) (2) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7) (8)

Missed dose

Not applicable in the usual sense -- sufentanil is given entirely under direct clinical supervision, with each dose timed and decided by the treating healthcare team based on ongoing monitoring, not by the patient.

Overdose

An overdose of sufentanil is a medical emergency that is managed immediately by the healthcare team on site, since sufentanil is only ever given in a monitored setting with resuscitation equipment, oxygen, and opioid-reversal medicines available. Signs include very slow or stopped breathing, extreme drowsiness, pinpoint pupils, and loss of consciousness. If a child or anyone else is accidentally exposed to a DSUVIA/Dzuveo tablet outside of this setting, this is a life-threatening emergency requiring immediate emergency medical care. (2) (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nausea and vomiting.

What to notice: Nausea and vomiting.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Dizziness and drowsiness.

What to notice: Dizziness and drowsiness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Itching (pruritus).

What to notice: Itching (pruritus).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Low blood pressure.

What to notice: Low blood pressure.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Muscle rigidity (with the injectable form, especially with rapid administration).

What to notice: Muscle rigidity (with the injectable form, especially with rapid administration).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of life-threatening slowed or stopped breathing (respiratory depression) — boxed_warning

Symptoms: Very slow, shallow, or stopped breathing; extreme drowsiness; bluish lips or fingertips; unresponsiveness.

Action: This is why sufentanil is only given in a setting with staff and equipment ready to manage it immediately -- if it occurs, the healthcare team responds at once with supportive care and, if needed, an opioid-reversal medicine. (1) (2)

Accidental exposure to a DSUVIA/Dzuveo tablet (especially in a child) — boxed_warning

Symptoms: Unusual sleepiness, slow or difficult breathing, unresponsiveness in someone who was not the intended patient.

Action: Seek emergency medical help immediately -- accidental exposure to even one tablet can be fatal, especially in children. This is why the tablet is dispensed and used only within a certified, controlled healthcare setting and never taken home. (2)

Signs of opioid dependence, misuse, or addiction developing — boxed_warning

Symptoms: Requesting sufentanil or opioids outside of clinically appropriate circumstances; signs of craving or misuse.

Action: Clinicians assess this risk before and throughout treatment; because sufentanil is only given in monitored clinical settings for short, defined periods, the ongoing-misuse risk is different from that of take-home opioids, but is still real and monitored. (1)

Profound sedation from combining opioids with benzodiazepines, other sedatives, or alcohol — boxed_warning

Symptoms: Extreme drowsiness, slowed breathing, coma.

Action: Tell the clinical team about all other sedating medicines, sleep aids, or recent alcohol use before treatment. (1)

Neonatal opioid withdrawal syndrome (with in-utero exposure, e.g. epidural use during labor) — high caution (documented outside the boxed warning, under pregnancy/fetal-neonatal risk)

Symptoms: In a newborn: irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, poor feeding.

Action: The care team monitors newborns for these signs after in-utero opioid exposure and manages them as needed; this is a recognized, real risk documented in the prescribing information, distinct from the boxed warning itself. (1)

Interactions

  • Strong CYP3A4 inhibitor medicines can raise sufentanil levels in the blood and increase the risk of serious, potentially fatal breathing problems -- this is part of the boxed warning for both forms. (1) (2)
  • Benzodiazepines, other sedatives, sleep medicines, and alcohol combined with sufentanil can cause profound sedation, breathing problems, coma, and death. (1)
  • Medicines with serotonergic effects (such as certain antidepressants) combined with sufentanil can increase the risk of serotonin syndrome. (2)
  • Monoamine oxidase (MAO) inhibitors have historically been a caution/contraindication with opioid analgesics including sufentanil-class agents; tell the clinical team about any MAO inhibitor use. (6)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Sufentanil crosses the placenta; used during labor (epidural, combined with bupivacaine) under direct medical supervision. Prolonged use in pregnancy can lead to neonatal opioid withdrawal syndrome in the newborn, which the care team monitors for and manages. (1) (2) (3) (4) (5) (6) (7) (8)

Breastfeeding

Discuss timing and monitoring with the treating clinician; sufentanil is only ever given under direct medical supervision, and any breastfeeding guidance should come from the care team managing the specific clinical situation. (1) (2) (3) (4) (5) (6) (7) (8)

Children

The sublingual tablet form (DSUVIA/Dzuveo) is not approved for children and accidental exposure in a child is specifically flagged as life-threatening in the boxed warning. Injectable sufentanil use in children is a specialist anesthesia decision. (1) (2) (3) (4) (5) (6) (7) (8)

Elderly

Elderly or debilitated patients may need lower doses and closer monitoring because of increased sensitivity to opioid effects, per Health Canada prescribing information. (1) (2) (3) (4) (5) (6) (7) (8)

Hepatic_impairment

Sufentanil is metabolized by the liver; dosing may need to be reduced and monitoring increased in patients with liver impairment. (1) (2) (3) (4) (5) (6) (7) (8)

Renal_impairment

Used under close monitoring in patients with kidney impairment as part of individualized, clinician-directed anesthesia or acute-pain management. (1) (2) (3) (4) (5) (6) (7) (8)

Source_ids

US-DAILYMED-SUFENTANIL-INJ-2026,US-DAILYMED-DSUVIA-2026,CA-HC-SUFENTANIL-PM-2026 (1) (2) (3) (4) (5) (6) (7) (8)

Monitoring

Before starting

  • Assessment of respiratory status and risk factors for respiratory depression
  • Review of all other sedating medicines, MAO inhibitors, and CYP3A4-interacting medicines
  • Assessment of personal/family history of substance use disorder
  • Confirmation that resuscitation equipment, oxygen, and opioid-reversal medicine are available on site

During treatment

  • Continuous monitoring of breathing, oxygen levels, heart rate, and level of consciousness throughout administration and recovery.
  • For the sublingual tablet: confirmation that the tablet has fully dissolved and that timing/maximum daily dose limits are respected.
  • Monitoring of the newborn for signs of opioid withdrawal after in-utero exposure via epidural use during labor.
(1) (2)

Storage

Sufentanil is stored, handled, and accounted for as a controlled substance by the healthcare facility's pharmacy and clinical staff, under strict security and diversion-control procedures -- it is never stored or kept by a patient at home.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information for both Sufentanil Citrate Injection and DSUVIA; verify against the current full label and local anesthesia/acute-pain protocols before prescribing or administering.

United States

Indication: Injectable -- anesthesia adjunct/primary anesthetic/epidural labor analgesia

Dose summary: IV analgesic adjunct 1-2 mcg/kg initial, 10-25 mcg maintenance increments; primary anesthetic 8-30 mcg/kg induction, 0.5-10 mcg/kg maintenance; epidural labor analgesia 10-15 mcg with 10 mL bupivacaine 0.125%, repeatable up to twice at >=1-hour intervals.

Renal context: No specific renal dose-adjustment schedule identified in the sources reviewed; individualize and monitor closely regardless of renal function. (1)

United States

Indication: Sublingual tablet (DSUVIA) -- acute pain, certified setting only

Dose summary: 30 mcg sublingually, no more than once hourly, maximum 12 tablets (360 mcg)/24h, maximum 72 hours of use.

Renal context: Not the primary focus of this product's label; used under close monitoring regardless of renal function. (2)

United Kingdom / European Union

Indication: Sublingual tablet (Dzuveo) -- acute moderate to severe pain, medically monitored setting only

Dose summary: No more than once hourly, maximum 720 mcg/day, maximum 48 hours of use.

Renal context: Not specifically detailed in the sources reviewed; individualize and monitor closely. (3)

Mechanism of action

Hepatic guidance

Hepatically metabolized; use with caution and closer monitoring in patients with hepatic impairment, per Health Canada and US labeling.

Overdose note

Manage with airway support, ventilation as needed, and an opioid antagonist (e.g. naloxone); always managed on-site given the controlled, monitored settings in which sufentanil is used. (1) (2) (6)

Frequently asked questions

Can I take sufentanil at home?

No. Sufentanil is never taken home. The injectable form is given only during surgery or labor by an anesthesia clinician, and the sublingual tablet (DSUVIA/Dzuveo) is used only inside a hospital, surgical center, or emergency department, under a restricted program that requires it to be stopped before you are discharged. (2)

Is sufentanil available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is confirmed authorised in the United States (both the injectable form and DSUVIA), the United Kingdom and European Union (as Dzuveo; an earlier EU sublingual product, Zalviso, was withdrawn in 2022 for commercial reasons), and Canada (an injectable product monograph is officially hosted by Health Canada). For Australia and New Zealand, direct searches this session did not find a confirmed marketed product (a live TGA search returned zero results, and sufentanil does not appear in the 2026 NZ Hospital Medicines List) -- this is reported honestly as 'unable to verify' rather than assumed either way. (1) (2) (3) (4) (6) (7) (8)

Why is DSUVIA/Dzuveo only used in hospitals and not sent home with patients?

Because of a real, boxed-warning-level risk: accidental exposure to or swallowing of even one tablet, especially by a child, can cause life-threatening breathing problems and death. The restricted program (REMS in the US) requires it to be dispensed and used only within certified healthcare settings, administered only by a healthcare professional, and stopped before discharge. (2)

What is the mechanism of action of sufentanil (as sufentanil citrate)?

Sufentanil is a synthetic opioid agonist acting primarily at mu-opioid receptors, structurally related to fentanyl but substantially more potent and lipophilic, giving it rapid onset and short context-sensitive duration suited to anesthesia and short-term acute-pain use. (1) (2) (6)

What is the generic name of Sufentanil?

The generic name is sufentanil (as sufentanil citrate). (1) (2) (3)

What class of drug is sufentanil (as sufentanil citrate)?

Sufentanil is classed as: Opioid agonist (synthetic phenylpiperidine derivative, fentanyl analogue); Schedule II / Controlled Drug. (1) (2) (3)

References

  1. SUFENTANIL CITRATE injection, solution, for intravenous and epidural use, CII -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-30 · source 1
  2. DSUVIA (sufentanil sublingual tablet, CII) -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, AcelRx Pharmaceuticals · United States · accessed 2026-07-30 · source 2
  3. Dzuveo 30 microgram sublingual tablet -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Aguettant Ltd · United Kingdom · accessed 2026-07-30 · source 3
  4. Dzuveo, INN-sufentanil citrate -- EPAR public summary and product informationEuropean Medicines Agency (EMA), EPAR · European Union · accessed 2026-07-30 · source 4
  5. Zalviso, INN-sufentanil -- EPAR (marketing authorisation withdrawn)European Medicines Agency (EMA) · European Union · accessed 2026-07-30 · source 5
  6. Sufentanil Citrate Injection, USP -- Product MonographHealth Canada Drug Product Database -- official product monograph host (pdf.hres.ca) · Canada · accessed 2026-07-30 · source 6
  7. TGA PICMI search for 'sufentanil' -- 0 documents returnedTherapeutic Goods Administration (TGA), Australia -- PICMI (Product/Consumer Medicine Information) repository · Australia · accessed 2026-07-30 · source 7
  8. Hospital Medicines List (HML), Edition March 2026New Zealand Hospital Medicines List, March 2026 edition (Health New Zealand / Te Whatu Ora, hosted via WHO essential-medicines document library) · New Zealand · accessed 2026-07-30 · source 8

Brand names by country

Single-ingredient sufentanil (as sufentanil citrate) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Sufentanil Citrate Injection (generic) (1)FDA approved currently labeled · 50 mcg/mL · Multiple US manufacturers under approved applications
  • DSUVIA (2)FDA approved currently labeled REMS restricted · 30 mcg · AcelRx Pharmaceuticals, Inc.

United Kingdom

  • Dzuveo (3)MHRA licensed emc smpc confirmed · 30 microgram · Aguettant Ltd

Canada

  • Sufentanil Citrate Injection, USP (generic) (6)Health Canada product monograph title confirmed full text not decoded this session · not independently verified this session · not independently verified this session
View brands in additional countries.

European Union

Dzuveo (4), Zalviso (5), Sufenta / Sufenta Forte (4)

This page provides general reference information about sufentanil and is not a substitute for advice from the clinical team administering your treatment. Sufentanil is only ever given by a healthcare professional in a hospital or certified setting -- there is no self-administration scenario this page describes.

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