What does it mean to prescribe something “off-label”?

“Off-label” prescribing means a medication is used in a way that’s different from how it was originally approved by the FDA—for example, for a different condition, dose, or age group.

This is a common and accepted part of medical practice. After a medication is approved, doctors may learn through research and clinical experience that it’s also effective for other conditions. When that happens, psychiatrists may prescribe it “off-label” if they believe it’s a good fit for a patient’s symptoms.

Many widely used mental health treatments—including some for anxiety, sleep, and ADHD—are prescribed off-label.

If your medication is being used off-label, your psychiatrist has considered the available evidence, their clinical experience, and your specific needs when recommending it. They’ll also monitor how you’re doing and make adjustments if needed.