Addiction, Abuse, and Misuse

• 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.

Accidental Exposure and DSUVIA REMS Program; Life-Threatening Respiratory Depression; Addiction, Abuse, and Misuse; Cytochrome P450 3A4 Interaction; and Risks from Concomitant Use With Benzoidiazepines or Other CNS Depressants

Accidental Exposure

• Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Because of the risk of life-threatening respiratory depression from accidental exposure, DSUVIA is available only through a restricted program called the DSUVIA REMS Program. DSUVIA should only be administered by a healthcare provider in a certified medically supervised healthcare setting. Discontinue use of DSUVIA prior to discharge or transfer from the certified medically supervised setting.   

Life-Threatening Respiratory Depression

• Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially during initiation. DSUVIA exposes users to the risks of opioid 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.
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.

Risks from Concomitant Use With Benzoidiazepines or Other CNS Depressants

• Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of sufentanil.   
• 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; and follow patients for signs and symptoms of respiratory depression and sedation.