If you have been struggling with symptoms of depression that do not respond to traditional treatments, you may be wondering, “Is Spravato federally legal?” The answer is yes, but only when your provider prescribes and administers it according to federal requirements.
Spravato is the brand name for esketamine nasal spray, a prescription medication approved by the U.S. FDA for adults with treatment-resistant major depressive disorder. It is also approved, together with an oral antidepressant, for depressive symptoms in adults with major depressive disorder who have acute suicidal thoughts or behaviors.
In 2025, the FDA approved Spravato as a standalone treatment for adults with treatment-resistant depression, meaning you may use it with or without an oral antidepressant for that indication. While anxiety is associated with depression, Spravato is not approved to treat anxiety alone. To learn more about the legality of this innovative treatment option, schedule your consultation with Upswing Psychiatry.
Confusion about Spravato usually centers on the word “ketamine.” Spravato contains esketamine, which is related to ketamine but is not the same as compounded ketamine products or at-home ketamine programs.
The FDA cautions about risks linked to compounded ketamine nasal spray, and ketamine itself is not FDA-approved to treat depression. Spravato, however, has FDA approval for certain depression-related indications when providers administer it under a strict safety program.
Spravato is also a Schedule III controlled substance. However, that does not mean it is illegal. Rather, it means the medication has accepted medical uses but also has potential risks, including abuse and misuse. Because of those risks, federal rules make Spravato legal but establish limitations on how we store, prescribe, administer, and monitor it.
Esketamine use is legal under federal law when your provider uses it through the Spravato Risk Evaluation and Mitigation (REMS) Program. This program is important because Spravato can cause serious side effects, including sedation, dissociation, respiratory depression, and risks related to abuse or misuse.
Under the REMS program, you may use Spravato only in a certified health care setting. You do not take the medication home. Instead, you self-administer the nasal spray at the office under the supervision of a trained provider. After your dose, you must stay under observation until we determine that you are ready to leave.
This structure is one reason Spravato is different from treatments advertised as take-home ketamine. The legal pathway for Spravato includes FDA approval, controlled-substance regulation, certified treatment settings, and required monitoring.
As a federally lawful treatment, Spravato's introduction phase includes the first 14 treatment sessions, not just the first month. A common schedule begins with treatment twice a week for four weeks, then once a week for four weeks, then once every other week for one month. Skipping a week during the last month helps us determine what maintenance therapy may look like for you.
Continuation or maintenance therapy begins after those first 14 rounds. From there, we customize your treatment schedule to meet your mental and physical needs. Some people may continue to receive treatment up to once weekly, while others may need it less frequently. We adjust your plan based on your symptoms, response, side effects, and goals.
At Upswing Psychiatry, we build Spravato care around safety, empathy, and individualized support. As one of the busiest single-center Spravato practices in the country, our team understands that clear communication and compassionate care are essential when you are seeking help for depression.
Is Spravato federally legal? Yes, it is legal when your clinician prescribes it for an FDA-approved use and administers it through the required REMS-certified process. The right setting helps protect your safety while giving you access to a treatment designed for serious depression when other options have not been enough. Contact us today to learn more about how Spravato treatment could help you.