Key takeaway
One is an FDA-approved nasal spray with a REMS program; the other is generally used off-label for depression. Here is what that means.
Different medicines, different approval status - SPRAVATO® contains esketamine and is FDA-approved for two specific adult depression uses. It is given only in REMS-certified settings with at least two hours of monitoring. - IV ketamine is FDA-approved as an anesthetic. When clinics use it for depression, that use is generally off-label — not an FDA-approved indication.
Why that matters to patients - Oversight: SPRAVATO® treatment follows a nationwide REMS with fixed monitoring requirements. Off-label ketamine protocols vary by clinic. - Coverage: Because SPRAVATO® has approved indications, insurers may cover it subject to their criteria (often prior authorization). Off-label IV ketamine for depression is frequently not covered — check with your plan. - Evidence: The two have different bodies of evidence. Comparing effectiveness is a question for a qualified clinician who knows your history.
Our editorial view Neither option is right for everyone. Ask any provider what is FDA-approved, what is off-label, how you will be monitored, and what you will be expected to pay.
Editorial explanation based on FDA labeling; not medical advice.
This page is informational and is not medical advice.