SUFENTA PRESERVATIVE FREE (sufentanil citrate) · RISING
Sufentanil Citrate is a potent opioid agonist indicated for use in adult and pediatric patients as an analgesic adjunct in balanced general anesthesia or as a primary anesthetic agent with 100% oxygen during major surgical procedures (e.g., cardiovascular or neurosurgery). It is specifically utilized in intubated and ventilated patients to maintain myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. Additionally, it is indicated for epidural administration in combination with low-dose bupivacaine for analgesia during labor and vaginal delivery.
How SUFENTA PRESERVATIVE FREE Works
Sufentanil is a highly potent opioid agonist. It provides analgesia and anesthesia through its action on opioid receptors in the central nervous system. When used as an adjunct in balanced general anesthesia, sufentanil is approximately 10 times as potent as fentanyl. When administered as a primary anesthetic agent with 100% oxygen, it is approximately 5 to 7 times as potent as fentanyl.
Details
- Status
- Prescription
- First Approved
- 1984-05-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SUFENTA PRESERVATIVE FREE Approval History
What SUFENTA PRESERVATIVE FREE Treats
1 indicationsSUFENTA PRESERVATIVE FREE is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Labor Pain
SUFENTA PRESERVATIVE FREE Boxed Warning
ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning. Sufentanil citrate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. ( 5.1 ) WARNING: ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning. Sufentanil citrate injection exposes users to risks of addiction, abuse, and misu...
WARNING: ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning. Sufentanil citrate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. ( 5.1 ) WARNING: ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning. Sufentanil citrate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. ( 5.1 )
SUFENTA PRESERVATIVE FREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06530563 | XiangyaHMZK | Ph 4 | not yet recruiting | the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery |
| NCT05831345 | CHUB-Methadone | Ph 3 | recruiting | Intraoperative Methadone for the Prevention of Postoperative Pain |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT00738192 CARAN | NMU-FY2008-311 NJFY0807311M | Ph 4 | completed | Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUFENTA PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)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 ventila...
WARNING: ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning. Sufentanil citrate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behav...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.