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Is trazodone FDA-approved for insomnia?

Short answer: No. Trazodone is FDA-approved only for major depressive disorder. Its use for insomnia, though extremely common, is off-label.

Editorially reviewed

This is one of the most important things to understand about trazodone's off-label popularity: the FDA has approved it only for depression. Its widespread use for sleep — usually at much lower doses than for depression — reflects decades of clinical experience with its sedating side effect, not a formal FDA review specifically for insomnia.

Not medical advice. This answer is general and educational. Your prescriber knows your full history and can give guidance specific to you.

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