General Information

Dsuvia (sufentanil) is an opioid agonist.

Dsuvia is specifically indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Dsuvia is supplied as a sublingual tablet. The recommended dosage of is 30 mcg sublingually as needed with a minimum of 1 hour between doses. Do not exceed 12 tablets in 24 hours. The maximum cumulative daily dose of sufentanil is 360 mcg or 12 tablets (12 tablets x 30 mcg/dose). 

Mechanism of Action

Dsuvia (sufentanil) is an opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principle therapeutic action of sufentanil is analgesia and sedation, thought to be mediated through opioid-specific receptors throughout the CNS. Like all full opioid agonists, there is no ceiling effect to analgesia. 

Side Effects

Adverse effects associated with the use of Dsuvia may include, but are not limited to, the following: 

• nausea
• headache
• vomiting
• dizziness
• hypotension

The Dsuvia drug label comes with the following Black Box Warning: 

• 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.
• 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.
• 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. 

Clinical Trial Results

The FDA approval of Dsuvia was based on one randomized, double-blind, placebo-controlled trial which enrolled 161 patients (age 18 to 69 years) with acute postoperative pain (pain intensity of ≥ 4 on a 0-10 numeric rating scale) after abdominal surgery (studied up to 48 hours). Patients were dosed with Dsuvia 30 mcg or placebo as needed with a minimum of 60 minutes between doses. Morphine sulfate 1 mg IV was available as rescue medication. Patients using Dsuvia had a statistically significantly greater SPID12 than patients using placebo. Approximately 22% of patients in the Dsuvia group and 65% of patients in the placebo group took rescue medication within the first 12 hours of the treatment phase.