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Sufentanil is approved by both the FDA and EMA for use in anesthesia and analgesia as part of anesthetic regimens ( epidural and intravenous use). Approvals are for sufentanil-containing products with indications for use as an anesthetic or analgesic during surgery.
Sublingual sufentanil (Dsuvia) is FDA-approved for managing moderate to severe acute pain in adults in medically supervised settings, such as hospitals and surgical centers. This is an analgesic indication, not labeled as a general anesthetic or "narcosis" agent.
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