Ketamine and Esketamine: Similar Names, Different FDA Status

Ketamine and esketamine are related medicines, but their names should not be used as if they describe one interchangeable depression treatment. The product, route of administration, intended use, and monitoring requirements all matter. A clinic saying that ketamine is FDA-approved may leave out an essential question: approved for what?

Ketamine's approval and off-label use

Ketamine is an FDA-approved anesthetic. Its use to treat psychiatric disorders is off-label: a clinician is using an approved drug outside its approved indication. Off-label prescribing can be part of medical practice, but it does not mean FDA has approved ketamine as a depression treatment.

Research supports antidepressant effects in some patients, including people with treatment-resistant depression. Still, evidence from supervised intravenous treatment cannot automatically validate a different route, a compounded formulation, or an at-home service. Each arrangement can involve different exposure, safeguards, and uncertainties.

Esketamine has a specific prescription label

Esketamine is one component of the ketamine mixture. Its branded nasal spray, Spravato, has specific FDA-approved psychiatric uses. The January 2025 label permits treatment-resistant depression in adults either alone or with an oral antidepressant. Older descriptions saying an oral antidepressant is always required are therefore incomplete.

The same label also includes depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behavior, used with an oral antidepressant. These indications are different. The label explicitly says effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated.

Why supervision matters

Spravato carries warnings about sedation, dissociation, respiratory depression, and abuse or misuse. It is available through a restricted risk-management program, with monitoring for at least two hours after administration. It is not a take-home nasal spray under that program.

Patients need to discuss blood pressure, other medicines, substance-use history, transportation, and activities after treatment. An appointment is not finished simply because the most noticeable subjective effects have faded. Clinical assessment determines when someone is ready to leave, and the medication guide provides additional restrictions.

Compounded does not mean FDA-approved

Compounded ketamine products are not FDA-approved. FDA has issued warnings about potential risks associated with compounded products used for psychiatric disorders, including oral formulations. Compounding and prescribing rules do not substitute for a product-specific FDA evaluation of safety, effectiveness, and manufacturing quality.

Ask a service to identify exactly what it provides: intravenous ketamine, approved esketamine, or a compounded product. Request a clear discussion of evidence, monitoring, adverse-event response, costs, and longer-term care. None should be presented as a guaranteed cure or a replacement for emergency psychiatric assessment. Someone in immediate danger needs urgent help, not a routine treatment booking.

Sources

• FDA: Spravato prescribing information, January 2025
• FDA: Monotherapy indication approval letter
• FDA: Compounding risk alerts