Key takeaway
What SPRAVATO® is, the two adult uses the FDA has approved, and how it differs from a pill you take at home.
The short answer SPRAVATO® is a prescription nasal spray containing esketamine. It is approved by the U.S. Food and Drug Administration (FDA) for two uses in adults:
- Treatment-resistant depression (TRD) — alone or together with an oral antidepressant.
- Depressive symptoms in adults with major depressive disorder (MDD) who have acute suicidal ideation or behavior — together with an oral antidepressant.
For the second use, the FDA label states that effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated, and that SPRAVATO® does not replace hospitalization when it is clinically needed. It is not approved for anyone under 18.
It is never a take-home medicine SPRAVATO® is available only through a restricted safety program called the SPRAVATO® REMS. Patients use the spray themselves, but only in a certified healthcare setting, under direct observation, and are monitored for at least two hours after each dose. The medicine is never dispensed for use at home.
Why the monitoring matters The FDA label carries a boxed warning for sedation, dissociation (feeling detached from yourself or your surroundings), respiratory depression, and abuse and misuse. It also carries the antidepressant class warning about increased suicidal thoughts and behaviors in children and young adults. After a treatment visit, you must not drive or operate machinery until the next day after a restful sleep, so you will need a ride home.
What "treatment-resistant" means In the label, TRD refers to major depressive disorder in adults who have not responded adequately to at least two different oral antidepressants in the current depressive episode. Whether SPRAVATO® is appropriate for you is a decision for you and a qualified prescriber.
Editorial note This guide is written by our editorial team from the current FDA prescribing information. It is general information, not medical advice. If you are in crisis, call or text 988, or call 911 if you are in immediate danger.
This page is informational and is not medical advice.