Off-label drug uses, explained honestly
“Off-label” means a drug is prescribed for something the FDA never approved it for. It is legal, common, and often evidence-based — but the honest picture (how good the evidence actually is, and what is approved instead) is what sellers skip. Here it is, per use.
What “off-label” does and doesn’t mean
A prescriber can legally use an approved drug for an unapproved condition, dose or age when their clinical judgment supports it — the FDA regulates drug approval, not the practice of medicine. Off-label is not the same as unproven: some off-label uses are backed by strong guideline-level evidence, others by little more than habit. The difference is the whole point of these pages.
- Trazodone for insomniaoff-label
Trazodone is used off-label for sleep, but it's FDA-approved only for depression and the AASM advises against it for chronic insomnia. See the evidence.
- Propranolol for anxietyoff-label
Propranolol is used off-label for performance anxiety: it blunts a racing heart and tremor but does not treat worry. Doses, risks and FDA-approved options.
- Gabapentin for anxietyoff-label
Gabapentin for anxiety is off-label: FDA-approved only for nerve pain and seizures. See the honest evidence, dosing, and the 2019 FDA breathing warning.
- Spironolactone for acneoff-label
Spironolactone is FDA-approved for blood pressure, not acne. The off-label evidence for women (SAFA trial, AAD guidelines), typical dosing, and real risks.
- Metformin for PCOSoff-label
Metformin is FDA-approved for diabetes, not PCOS — a common off-label use. What the 2023 international guideline says it helps, honest dosing, and key risks.
- Amitriptyline for insomniaoff-label
Amitriptyline is FDA-approved for depression, not sleep. Low-dose (10-25 mg) use for insomnia is off-label with limited evidence and anticholinergic risks.
General reference information, not medical advice. Off-label prescribing is a decision for you and a licensed prescriber. Each page cites the FDA label and the specialty guidelines behind it.