Is Spravato® FDA approved?

Yes, Spravato^® was first approved by the FDA in 2019 for use alongside an oral antidepressant to treat treatment-resistant depression (TRD) in adults—typically defined as depression that hasn’t improved after trying at least two antidepressants. Spravato^® is also approved for adults with major depressive disorder (MDD) who are experiencing acute suicidal thoughts or behavior.

In early 2025, the FDA expanded its approval, allowing Spravato^® to be used on its own, making it the first and only FDA-approved monotherapy for adults with TRD.