Ketamine Nasal Spray (Esketamine and Spravato)

What is ketamine nasal spray?

Ketamine nasal spray usually refers to Spravato, the brand name for esketamine. Esketamine is one half of the ketamine molecule. Ketamine itself is a mix of two mirror-image molecules, and esketamine is the more potent S-form isolated and turned into a nasal spray. It is a Schedule III controlled substance, which means it has accepted medical use but also a recognized potential for misuse.

Spravato is used for two situations in adults: treatment-resistant depression, meaning major depressive disorder that has not improved after trying at least two different antidepressants, and depressive symptoms in adults with major depression who have acute suicidal thoughts or actions. It is a prescription treatment given in a doctor's office or clinic, not a spray you fill at a pharmacy and use at home.

It helps to separate three things people lump together. Spravato (esketamine) is the FDA-approved nasal spray. Racemic ketamine given as an IV infusion is used off-label for depression but is not FDA-approved for that purpose. Compounded ketamine nasal sprays or lozenges mailed for home use are also not FDA-approved. The differences matter for safety, oversight, and cost.

Is ketamine nasal spray FDA-approved?

Yes, but with important limits. The FDA first approved Spravato in 2019 for treatment-resistant depression, to be used together with an oral antidepressant. In 2020 the FDA expanded that approval to cover depressive symptoms in adults with major depression who have acute suicidal ideation or behavior.

In January 2025 the FDA approved Spravato as a standalone treatment, or monotherapy, for treatment-resistant depression. A prescriber can now use it without also prescribing an oral antidepressant, which was not true before 2025. It is the first and only nasal spray of its kind approved to be used on its own for this condition.

What is not FDA-approved is compounded nasal ketamine and at-home ketamine products. Compounded drugs are not reviewed by the FDA for safety, effectiveness, or quality before they are sold, and the agency has issued alerts about compounded ketamine used for psychiatric conditions without a provider present to monitor sedation, dissociation, and vital signs. If a service offers to mail you a ketamine spray to use alone at home, that is a different product from Spravato, with a different level of oversight.

How does esketamine work?

Most standard antidepressants act on serotonin, norepinephrine, or dopamine and typically take four to six weeks to show a full effect. Esketamine works through a different chemical system. It blocks the NMDA receptor, part of the brain's glutamate signaling network, which is thought to trigger a rapid strengthening of connections between neurons.

Because of this different mechanism, some people notice improvement in mood within hours to days rather than weeks, which is one reason it is studied in people whose depression has not responded to other medications. Rapid relief is not guaranteed, and esketamine is meant to be part of an ongoing treatment plan, not a one-time fix.

What a Spravato session is really like

Spravato can only be given through a restricted program called the Spravato REMS, short for Risk Evaluation and Mitigation Strategy. In plain terms, you cannot take it at home. You receive it at a certified clinic where staff can monitor you.

A typical visit looks like this. You arrive, and staff check your blood pressure, since esketamine can raise it temporarily. You self-administer the nasal spray under supervision, usually a set of sprays spaced a few minutes apart. Then you rest in the clinic while a health care provider observes you for at least two hours, watching for sedation, dissociation, and changes in blood pressure. Many people feel spacey, drowsy, or briefly detached from their surroundings during this window.

You are not allowed to drive for the rest of the day, so you need to arrange a ride home. You also should not eat for a couple of hours or drink for at least 30 minutes before your dose to reduce nausea. Plan on roughly two and a half hours per appointment door to door, twice a week during the first month. The time commitment is real and worth planning around.

Doses and treatment schedule

Your prescriber decides your dose and schedule; what follows is the general shape of treatment so you can plan, not instructions. Spravato comes in two approved dose levels, 56 mg and 84 mg, and every dose is followed by the same in-clinic monitoring period of at least two hours.

For treatment-resistant depression, treatment starts with an induction phase of about four weeks with visits twice a week. After induction, visits usually spread out, often to once a week and then to once every one or two weeks for maintenance. For major depression with acute suicidal thoughts, treatment runs twice weekly for four weeks alongside standard care, including an oral antidepressant.

Do not adjust or stop on your own. Your clinician weighs how well the medication is working against side effects at each phase, and the schedule is designed to be reassessed regularly rather than continued indefinitely without review.

Side effects, warnings and who should avoid it

Spravato carries an FDA boxed warning, the agency's strongest, covering sedation, dissociation, respiratory depression, potential for abuse and misuse, and suicidal thoughts and behaviors. These effects are common. In the clinical trials summarized in the prescribing information, dissociation was reported in 41 to 48 percent of patients taking Spravato versus 9 to 13 percent on placebo, and roughly half of patients experienced sedation. A small fraction briefly lost consciousness. The two-hour observation period exists specifically to manage these risks.

Other common side effects include dizziness, nausea, a spinning sensation, a temporary rise in blood pressure, reduced sense of touch, anxiety, and feeling drunk. Most fade within the monitoring window. Because it can raise blood pressure and cause dissociation, it is generally avoided in people with certain aneurysms, a history of bleeding in the brain, or uncontrolled high blood pressure.

One point the marketing rarely stresses: the FDA states that Spravato has not been shown to prevent suicide or reduce suicidal thoughts on its own. It can rapidly ease depressive symptoms in a crisis, but it is not a substitute for close monitoring and a full safety plan. If you are in crisis, call or text 988 to reach the Suicide and Crisis Lifeline.

FDA-approved Spravato vs at-home compounded ketamine

This is the distinction that trips people up most. Spravato is a specific, standardized, FDA-approved product delivered under supervision with monitoring built in. Compounded ketamine, often sold as troches, lozenges, or nasal sprays through telehealth companies, is mixed by compounding pharmacies and is not FDA-approved for depression. There is no requirement that anyone observe you while you take it.

That lack of monitoring is the core safety concern, and it is the reason the FDA has issued alerts about compounded ketamine marketed for psychiatric conditions. Ketamine can cause sedation and dissociation strong enough to be dangerous if you are alone, and long-term unsupervised use raises questions about bladder damage, misuse, and dependence. Compounded products can also cost less and be more convenient, which is exactly why they are marketed heavily.

Neither route is automatically right or wrong for a given person, but you deserve to know which one you are being offered. Ask directly whether a treatment is FDA-approved Spravato given in a REMS-certified clinic or a compounded product for home use, and weigh the difference in oversight with your prescriber.

Cost, access and insurance in 2026

Spravato is expensive. The medication alone can run several hundred to over a thousand dollars per dosing session before insurance, and that is on top of the clinic's charge for the monitoring visit. Because the induction phase is twice weekly, early costs add up quickly.

Many commercial insurance plans and Medicare now cover Spravato for approved uses, usually after prior authorization that documents you have tried other antidepressants without success. The manufacturer runs a copay savings program for eligible commercially insured patients, and clinics can usually check your coverage before you start. Access has widened as more psychiatry practices become REMS-certified, but availability still varies by region.

If a full course of Spravato is out of reach, a psychiatrist can talk through other evidence-based options for treatment-resistant depression, including augmentation strategies and, in some cases, treatments like transcranial magnetic stimulation.

Questions to ask before you start

A short phone call can save you weeks of surprises. Before you book a first appointment, it is reasonable to ask any clinic the following, and a good clinic will answer all of them without hesitation.

• Are you certified in the Spravato REMS program, and is this FDA-approved esketamine rather than compounded ketamine?
• Who monitors me during the two-hour observation period, and what happens if my blood pressure spikes?
• What will my insurance cover, and what are the separate charges for the drug and the monitoring visit?
• Will you coordinate with my current psychiatrist or therapist, and how do you decide when to space out or stop treatment?
• What is your plan if I do not improve after the first month?