Ketamine and Spravato treatment: how it works, what it costs, how to find a provider

Spravato (esketamine nasal spray)

The FDA approved Spravato (esketamine) nasal spray for treatment-resistant depression on 5 March 2019 (NDA 211243). The Spravato REMS, the restricted distribution programme it can only be given under, was approved the same day. (U.S. Food and Drug Administration, Drugs@FDA, 5 Mar 2019; U.S. Food and Drug Administration, Drugs@FDA, 2026)

The current label approves Spravato for two uses in adults: treatment-resistant depression, either on its own or with an oral antidepressant, and depressive symptoms in major depressive disorder with acute suicidal thoughts or behaviour, together with an oral antidepressant. The label states that its effectiveness in preventing suicide or reducing suicidal thoughts or behaviour has not been demonstrated, and that it is not approved for children. (U.S. National Library of Medicine, DailyMed (Janssen label), 24 Sep 2026)

Johnson & Johnson announced on 21 January 2025 that the FDA had approved Spravato as a monotherapy, without an oral antidepressant, for adults with major depressive disorder who had not responded adequately to at least two oral antidepressants. (Johnson & Johnson (press release), 21 Jan 2025)

How it is given: the REMS

Under the Spravato REMS, the drug may only be dispensed and given in healthcare settings certified in the programme, never taken home. A certified outpatient setting must have a prescriber on site during administration and monitoring, staff and a pulse oximeter to monitor patients, and must watch each patient for at least 2 hours for sedation, dissociation, breathing problems and changes in vital signs, then file a Patient Monitoring Form within 7 days. Outpatients are enrolled in the REMS with a healthcare provider before the first dose. (U.S. Food and Drug Administration, REMS@FDA, 24 Jun 2026; U.S. National Library of Medicine, DailyMed (Janssen label), 24 Sep 2026)

Spravato carries a boxed warning for sedation, dissociation, respiratory depression, abuse and misuse, and suicidal thoughts and behaviours (an antidepressant class warning for people aged 24 and under). Patients must be monitored for at least 2 hours at each treatment session and then assessed before they leave. It is a Schedule III controlled substance. (U.S. National Library of Medicine, DailyMed (Janssen label), 24 Sep 2026)

The label contraindicates Spravato in people with aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arteries) or an arteriovenous malformation, a history of intracerebral haemorrhage, or hypersensitivity to esketamine or ketamine. It raises blood pressure at all recommended doses, peaking about 40 minutes after a dose and lasting about 4 hours. (U.S. National Library of Medicine, DailyMed (Janssen label), 24 Sep 2026)

Finding a certified treatment centre

The FDA does not publish a list of certified Spravato treatment settings. The manufacturer's website offers a search tool for healthcare offices certified to administer Spravato and says there are about 3,000 such centres in the US; the label says the REMS programme (spravatorems.com, 1-855-382-6022) lists certified pharmacies. A patient can also ask their own psychiatrist or doctor, who may be able to offer it in their office. (Janssen Pharmaceuticals (manufacturer's website), current page; U.S. National Library of Medicine, DailyMed (Janssen label), 24 Sep 2026; U.S. Food and Drug Administration, REMS@FDA, 24 Jun 2026)

Off-label ketamine clinics

Ketamine itself is FDA approved only as an intravenous or intramuscular anaesthetic. The FDA stated in October 2023 that ketamine is not FDA approved for the treatment of any psychiatric disorder, that it has not determined ketamine is safe and effective for depression, anxiety, PTSD or OCD, and that compounded ketamine products, including oral forms, have not been evaluated for safety, effectiveness or quality. It warned that using them without monitoring by a health care provider may put patients at risk of serious adverse events. Intravenous ketamine clinics for depression are therefore prescribing off-label. (U.S. Food and Drug Administration, 10 Oct 2023)

Ketamine, its salts, isomers and salts of isomers are Schedule III controlled substances under federal law (21 CFR 1308.13); esketamine, sold as Spravato, is one of those isomers and its label lists it as Schedule III. (eCFR (Office of the Federal Register), current; U.S. National Library of Medicine, DailyMed (Janssen label), 24 Sep 2026)

The FDA lists the known safety concerns of ketamine products as abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression (slowed breathing) and lower urinary tract and bladder symptoms. (U.S. Food and Drug Administration, 10 Oct 2023)

What it costs

In its June 2019 final evidence report the Institute for Clinical and Economic Review (ICER) judged esketamine 'low value for money' at its announced list price of $32,400, and put a fair value-based price at $17,700 to $25,200 a year, a 25 to 52 percent discount. (Institute for Clinical and Economic Review, 20 Jun 2019)

We found no peer-reviewed or official source for what off-label ketamine infusions cost, so we give no figure. Insurance coverage depends on your plan; ask your insurer and the clinic before the first session.

Medicines that interact

• Spravato is approved for use alongside an oral antidepressant.
• Spravato is approved for use alongside an oral antidepressant.
• May raise blood pressure; the label asks for close monitoring.
• More sedation.
• More sedation; respiratory depression has been reported with Spravato.
• More sedation.
• May raise blood pressure.

Questions to ask any provider

1. Is this Spravato under the REMS, or off-label ketamine? Which form (nasal spray, infusion, injection, lozenge), and who prescribed it?
2. Who assesses me before the first dose, and do they have my full medication list and medical history?
3. Who is on site while I am monitored, for how long, and what equipment do you use to monitor breathing and blood pressure?
4. How is my blood pressure checked before and after each dose, and what happens if it is too high?
5. What does the full course cost, in writing, and what will my insurance cover? Is anything billed separately?
6. How do you measure whether it is working, and when would you stop?
7. How do I get home after a session, and when can I drive again?
8. What happens if I have a bad reaction after I leave?