Who qualifies for Spravato?

On 21 January 2025, the FDA approved Spravato as a monotherapy for adults with treatment-resistant depression — meaning it can now be prescribed for that indication on its own, without a concurrent oral antidepressant.

Before that, the treatment-resistant depression indication required Spravato to be used together with an oral antidepressant. That requirement no longer applies to that indication.

Two things follow, and both are worth knowing:

Most sources you will read are out of date on this. A large share of clinic pages, directories, and general summaries still describe Spravato as something used "always alongside an oral antidepressant". That was correct until January 2025 and is not correct now for treatment-resistant depression. If you see it, the page has not been updated since then, which is worth factoring into how you read the rest of it.

The other indication did not change. For depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behaviour, the label still specifies use in conjunction with an oral antidepressant. Both indications remain adults only.

Whether monotherapy or combination therapy makes sense for a particular person is a clinical decision. The change is that it is now a decision rather than a foregone conclusion.

The "at least two antidepressants" criterion is more specific than most people assume, and this is where prior-authorisation requests most often come unstuck. Three conditions generally have to hold for a previous medication to count.

Adequate dose. A medication taken at a starting dose that was never increased usually does not count as a trial. The dose has to have reached a therapeutic level.

Adequate duration. Antidepressants are typically given six to eight weeks at an adequate dose before response is judged. Two weeks and then stopping does not count, even though it may have felt like a fair attempt at the time.

In the current episode. A medication that failed during a depressive episode fifteen years ago generally does not count towards the current one.

This is why it is worth reconstructing your own medication history before your appointment — the medications, the doses, roughly when and for how long, and why each was stopped. Two distinctions matter to the assessment and often get blurred in memory: a medication stopped because it did not work is a failed trial, while one stopped because of side effects at a low dose may not be. Similarly, a medication you stopped taking for a while is a different thing from one that you took faithfully and that did not help.

If your records are thin, say so rather than guessing. Your prescriber can often reconstruct more than you can from pharmacy records, and an accurate history serves you better than an optimistic one — a prior-authorisation request built on a shaky history is a request that gets denied.

The insurance page covers what documentation payers ask for.

The FDA label sets out contraindications — situations where the drug should not be used at all. As written, these include:

• Aneurysmal vascular disease affecting the thoracic or abdominal aorta, intracranial vessels, or peripheral arteries.
• Arteriovenous malformation.
• A history of intracerebral haemorrhage.
• Hypersensitivity to esketamine, ketamine, or any of the excipients.

The reason the first three sit together: esketamine raises blood pressure after dosing, and a sudden increase is dangerous where a vessel is already compromised.

Beyond outright contraindications, the label describes situations calling for caution and closer assessment rather than exclusion — including cardiovascular and cerebrovascular conditions, a history of psychosis, and a history of substance use disorder. These are judgement calls for a prescriber, not disqualifications you can read off a list.

Age. Both indications are for adults 18 and over. Spravato is not approved for anyone under 18.

Pregnancy and breastfeeding. The label advises against use in pregnancy and while breastfeeding. This is a conversation to have with your prescriber rather than a question to settle from a website.

This is a summary of what the label says, not a complete safety assessment, and it cannot account for your other medications or your medical history. The full prescribing information is linked in the sources below.