FDA-approved uses
SPRAVATO® has two labeled uses in adults. A qualified healthcare professional must evaluate diagnosis, treatment history, medical risks, and whether care in a certified setting is appropriate.
SPRAVATO® is approved as monotherapy or together with an oral antidepressant for adults with treatment-resistant depression. The FDA label defines this population as adults who have not responded adequately to at least two oral antidepressants in the current depressive episode.
For this indication, SPRAVATO® is used together with an oral antidepressant. Its effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated, and it does not replace hospitalization when clinically warranted.
SPRAVATO® (esketamine) nasal spray is FDA-approved for adults with treatment-resistant depression — depression that has not improved after at least two antidepressants, used alone or with an oral antidepressant.
Read guideSPRAVATO® is FDA-approved, together with an oral antidepressant, for adults with major depressive disorder who have acute suicidal ideation or behavior — as part of urgent, supervised care.
Read guideSPRAVATO® has boxed warnings for sedation, dissociation, respiratory depression, abuse and misuse, and suicidal thoughts and behaviors. It is not approved for pediatric patients and is available only through the SPRAVATO® REMS program.
Source: FDA Prescribing Information for SPRAVATO®, revised January 2025. This page is educational and is not medical advice.