Dsuvia (Sublingual)

Accidental exposure to or ingestion of sufentanil sublingual tablets, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, sufentanil sublingual tablets are only available through a restricted program called the Dsuvia REMS Program. Sufentanil sublingual tablets must only be dispensed to patients in a certified medically supervised healthcare setting. Discontinue use of sufentanil sublingual tablets prior to discharge or transfer from the certified medically supervised healthcare setting.Serious, life-threatening, or fatal respiratory depression may occur with the use of sufentanil sublingual tablets. Monitor for respiratory depression, especially during initiation of sufentanil sublingual tablets.Sufentanil sublingual tablets 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 sufentanil sublingual tablets, and monitor all patients regularly for the development of these behaviors or conditions.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. Follow patients for signs and symptoms of respiratory depression and sedation .