Dsuvia is a prescription medication used in adults in a certified, medically supervised, healthcare setting for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 

Dsuvia belongs to a group of drugs called opioids. These work by changing the way pain is perceived by the brain.

This medication comes as a sublingual tablet to be administered by a healthcare provider. Do not chew or swallow the tablet. Do not eat or drink and minimize talking for 10 minutes after receiving the tablet.

Common side effects include nausea, headache, vomiting, dizziness, and low blood pressure. Dsuvia can also cause drowsiness. Do not drive or operate heavy machinery until you know how Dsuvia affects you.

WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM; LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Accidental Exposure and Dsuvia Risk Evaluation and Mitigation Strategy (REMS) Program

Accidental exposure to or ingestion of Dsuvia, especially in children, can result in respiratory depression and death.  Because of the potential for life-threatening respiratory depression due to accidental exposure, Dsuvia is only available through a restricted program called the Dsuvia REMS Program.

• Dsuvia must only be dispensed to patients in a certified medically supervised healthcare setting.

• Discontinue use of Dsuvia prior to discharge or transfer from the certified medically supervised healthcare setting.  

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Dsuvia. Monitor for respiratory depression, especially during initiation of Dsuvia,

Addiction, Abuse, and Misuse

Dsuvia exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Dsuvia, and monitor all patients regularly for the development of these behaviors or conditions

Cytochrome P450 3A4 Interaction

The concomitant use of Dsuvia with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression.  In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving Dsuvia and any CYP3A4 inhibitor or inducer.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

• Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate.

• Limit dosages and durations to the minimum required.

• Follow patients for signs and symptoms of respiratory depression and sedation.