Substance guideSubstances 1 min read
Ketamine treatment: what's approved and what isn't
Ketamine is legal to prescribe in the US. A nasal form, esketamine (Spravato), is FDA-approved for treatment-resistant depression; IV ketamine for depression is legal but off-label.
PsiloAtlas editorial · AI-assisted information, not clinical review · Reviewed 2026-10-12
What it is
Ketamine is an anesthetic approved in the US since 1970. At lower doses it can rapidly reduce depressive symptoms, often within hours.
What the research shows
Esketamine was approved after trials showing faster improvement than placebo when added to an oral antidepressant in people whose depression had not responded to other treatments. Effects from a single dose usually fade, so treatment is given as a series.
Risks
Ketamine raises blood pressure, causes dissociation and sedation, and can be misused. Because of sedation, dissociation and misuse risks, the FDA requires Spravato to be given in a certified medical office where a health care provider monitors the patient, under its REMS safety program. In October 2023 the FDA warned patients about the risks of compounded ketamine products, including oral forms used at home.
Legal status
Ketamine is in Schedule III of the federal Controlled Substances Act (21 CFR 1308.13), legal in every state with a prescription.
Spravato is FDA-approved for treatment-resistant depression (March 2019).
Any licensed prescriber may use ketamine off-label; state rules on clinics and telehealth prescribing vary.