Esketamine, Ketamine, and Compounded Products: How to Read the Differences

When reading about depression treatment, it is easy to see ketamine, esketamine, nasal spray, and compounded medication used almost interchangeably. They should not be. The 2025 FDA expansion for Spravato applies to a specific prescription esketamine nasal spray, not every product described as ketamine therapy. The approval letter identifies the product and indication.

Begin with the exact product name

Spravato is the brand name of an esketamine nasal spray with FDA-approved prescribing information. Its treatment-resistant depression indication allows use alone or with an oral antidepressant in adults. It also has a separate indication for depressive symptoms in adults with major depression and acute suicidal ideation or behavior, used with an oral antidepressant. Check the FDA indications.

Those details matter more than an advertisement’s broad description of a ketamine-based service. Before discussing effectiveness, ask the provider to write down the medication name, formulation, route, and condition being treated. That creates a clear starting point for informed consent.

A route of administration is not an approval

Nasal spray describes how a drug enters the body. It does not, by itself, identify the ingredient, establish that the product is Spravato, or confirm that it has an FDA-approved psychiatric indication. FDA has issued a separate safety alert about compounded ketamine nasal spray. The FDA’s compounding alert index lists that warning.

The same caution applies to oral products. A tablet, liquid, or other oral formulation should be evaluated according to evidence for that particular treatment—not assumed equivalent to an approved nasal spray because both are discussed in ketamine-related coverage.

What does compounded mean?

FDA’s ketamine warning explains that compounded drugs are not FDA approved and that the agency has not evaluated their safety, effectiveness, or quality before marketing. It also states that compounded medicines can serve a medical need when an approved medicine is not medically appropriate. Those two points belong in the same conversation: compounding is not automatically proof of poor care, but it is not an approval shortcut. Read the reproduced FDA safety communication.

Ask why a compounded preparation is being proposed for you, which pharmacy supplies it, and what evidence supports the specific formulation and treatment setting. You can request this explanation without assuming the treatment is either appropriate or inappropriate in advance.

Do not transfer evidence between products automatically

A 2025 randomized trial examined esketamine nasal spray as monotherapy for treatment-resistant depression. Its findings address that study’s population, formulation, doses, and comparison with placebo. They do not directly establish effectiveness for every oral or compounded ketamine product. The trial description identifies what was actually studied.

When a provider cites research, ask a simple question: is this the same treatment being offered to me? If the answer is no, ask how the clinician accounts for the difference. A transparent answer should distinguish direct evidence from clinical judgment or extrapolation.

Monitoring is another important distinction

Spravato is administered under supervision through a restricted safety program, with monitoring for at least two hours afterward. Its label includes risks such as sedation, dissociation, respiratory depression, and abuse or misuse. Read the boxed warning and monitoring requirements.

FDA’s compounded ketamine warning also raises concern about treatment without monitoring, including risks involving sedation, dissociation, and changes in vital signs. An easier delivery method should not be interpreted as evidence that clinical risks have disappeared.

A comparison checklist for patients

• What is the exact drug and formulation?
• Is this particular product FDA approved?
• Is the proposed use within its approved indication?
• Which studies support this route and condition?
• Who monitors treatment, and what happens in an emergency?
• How will benefit, adverse effects, and ongoing need be reviewed?

The goal is not to choose a treatment by terminology alone. It is to make sure the name, evidence, and care plan refer to the same thing. Talk with a qualified clinician before deciding which product or treatment setting is appropriate for you.

Sources

• FDA: Spravato prescribing information
• FDA: Compounding risk alerts
• JAMA Psychiatry: Esketamine monotherapy trial