Overview

Sufentanil is an opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent. It is administered by the intravenous, epidural and sublingual routes. Also known as Dsuvia, the sublingual form is used for the management of acute pain in adults that is severe to warrant the use of an opioid analgesic in certified medically supervised healthcare settings, including hospitals, surgical centers, and emergency departments . Consideration may be made in the future for the use of the sublingual form in the US military in cases where analgesia is required immediately . The sublingual form, manufactured by AcelRx Pharmaceuticals, Inc. (AcelRx), was approved on November 2, 2018 . This route of administration is intended to be a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage acute pain without difficult intravenous or epidural administration , .

Indication

The indications for this drug are as follows:

Associated Conditions

Acute Pain
Severe Acute Pain

Research Report

Published: Jul 24, 2025

A Comprehensive Monograph on Sufentanil (DrugBank ID: DB00708): Pharmacology, Clinical Use, and Risk Management

Section 1: Executive Summary

Sufentanil is a potent, small-molecule synthetic opioid analgesic belonging to the 4-anilidopiperidine class of drugs. As a thienyl derivative of its parent compound, fentanyl, it represents one of the most powerful opioids utilized in modern clinical practice.[1] Its pharmacological profile is defined by an exceptionally high affinity and selectivity for the μ-opioid receptor, resulting in an analgesic potency estimated to be 5 to 10 times that of fentanyl and 500 to 1,000 times that of morphine.[1] This extreme potency, combined with high lipophilicity, facilitates a rapid onset of action, making it a cornerstone of anesthetic and analgesic practice in specific, high-acuity medical environments.[4]

The clinical applications of sufentanil are highly specialized and reflect its unique pharmacodynamic and pharmacokinetic properties. It is primarily administered intravenously as an analgesic adjunct to maintain balanced general anesthesia or as a primary anesthetic agent, particularly in major surgical procedures such as cardiovascular and neurosurgery, where its ability to ensure hemodynamic stability by attenuating the sympathetic stress response is highly valued.[3] Additionally, it is used via the epidural route, typically in combination with a local anesthetic like bupivacaine, to provide effective analgesia during labor and vaginal delivery.[5] A significant innovation in its delivery is the development of a sublingual tablet formulation (Dsuvia®, Dzuveo®), approved for the management of severe, acute pain exclusively within certified, medically supervised healthcare settings.[6]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia	2025/07/29	NCT07092384	Not Applicable	Recruiting	Tongji Hospital
The Effect-site Concentration of Remifentanil Blunting Endotracheal Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate	2025/07/28	NCT07089173	Not Applicable	Recruiting	Peking University Shenzhen Hospital
Varied Remimazolam Dosages for Pediatric Endoscopy	2025/07/24	NCT07083440	Not Applicable	Completed	Children's Hospital of Hebei Province
Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy	2025/07/24	NCT07084753	Not Applicable	Not yet recruiting	IVO JURISIC
Subanesthetic Esketamine for Hemodynamic Stability and Recovery in Elderly Thoracic Surgery Patients	2025/07/14	NCT07064408	Not Applicable	Completed	Hebei Medical University Fourth Hospital
Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery	2025/06/18	NCT07026162	Not Applicable	Recruiting	YanYing Xiao
Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis	2025/06/13	NCT07019818	Phase 4	Not yet recruiting	University Hospital, Limoges
The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy	2025/06/12	NCT07018375	Phase 4	Not yet recruiting	Tianjin Medical University General Hospital
Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial	2025/05/25	NCT06990893	Not Applicable	Recruiting	Anqing Municipal Hospital
Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery	2025/05/06	NCT06958393	Phase 4	Not yet recruiting	Qianfoshan Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sufentanil Citrate	Akorn	17478-050	INTRAVENOUS, EPIDURAL	50 ug in 1 mL	3/31/2014
Sufentanil Citrate	West-Ward Pharmaceuticals Corp.	0641-6110	EPIDURAL, INTRAVENOUS	0.05 mg in 1 mL	9/17/2018
Sufentanil Citrate	West-Ward Pharmaceuticals Corp.	0641-6111	EPIDURAL, INTRAVENOUS	0.05 mg in 1 mL	9/17/2018
Sufentanil Citrate	West-Ward Pharmaceuticals Corp.	0641-6112	EPIDURAL, INTRAVENOUS	0.05 mg in 1 mL	9/17/2018
Dsuvia	AcelRx Pharmaceuticals, Inc.	61621-430	SUBLINGUAL	30 ug in 1 1	12/18/2023
Sufentanil Citrate	Hospira, Inc.	0409-3382	EPIDURAL, INTRAVENOUS	50 ug in 1 mL	7/17/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Dzuveo	Laboratoire Aguettant,Laboratoire Aguettant,1, rue Alexander Fleming,69007 Lyon,FRANCE	Authorised	6/25/2018

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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