What changed
The January 2025 prescribing information lists SPRAVATO® for adult TRD either as monotherapy or with an oral antidepressant.
What changed The SPRAVATO® prescribing information revised in January 2025 (NDA 211243) describes use for treatment-resistant depression in adults either as monotherapy or in conjunction with an oral antidepressant. Earlier labeling described TRD use together with an oral antidepressant.
What did not change - The second approved use — depressive symptoms in adults with MDD and acute suicidal ideation or behavior — remains in conjunction with an oral antidepressant, with the stated limitation that effectiveness in preventing suicide has not been demonstrated. - SPRAVATO® remains available only through the REMS in certified settings, with monitoring for at least two hours after each dose. - The boxed warnings remain in place, and it is not approved for patients under 18.
What this means for patients Whether SPRAVATO® is used alone or with an oral antidepressant is a decision for you and your prescriber. You can search our directory for treatment centers near you.
General information, not medical advice. Source: FDA prescribing information.
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This report is educational and is not medical advice. Coverage, availability and eligibility can change; verify details with the named source or your care team.