FDA label
What is Spravato used for?
Spravato contains esketamine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant; Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.”
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Spravato, solution
Indications and Usage, quoted from the label by Janssen Pharmaceuticals, Inc. (NDA211243). Cross-references to other label sections are left out.
SPRAVATO is indicated for the treatment of:
- Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant
- Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant
Limitations of Use
- The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated [see Clinical Studies]. Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO.
- SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established.
Source: DailyMed label, set id d81a6a79-a74a-44b7-822c-0dfa3036eaed, version 21, effective September 22, 2026. NDC 50458-028, one of 1 listing for this product.
Questions
What is Spravato used for?
The FDA label says: “SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant; Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.”
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.