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Trazodone in Children and Teens

Why trazodone is not FDA-approved for pediatric use, and what that means in practice.

Editorially reviewed
Key points
  • Safety and effectiveness not established in pediatric patients per FDA label
  • Any pediatric use would be off-label and specialist-guided
  • Boxed warning monitoring is especially relevant in this age group

Trazodone's FDA prescribing information states that safety and effectiveness in the pediatric population have not been established. Any use in children or teenagers would be an off-label decision, typically made by a specialist (such as a child psychiatrist) after careful consideration of alternatives.

The antidepressant-class boxed warning about increased suicidal thoughts and behaviors specifically applies to patients under 25, making careful monitoring especially important in any pediatric or young-adult use.

References

  1. Trazodone: MedlinePlus Drug Information. U.S. National Library of Medicine (MedlinePlus). View source (opens in a new tab) Accessed August 8, 2026
  2. Trazodone Hydrochloride Tablets — FDA Prescribing Information. DailyMed / U.S. Food & Drug Administration. View source (opens in a new tab) Accessed August 8, 2026
Not medical advice. This article is educational and does not replace guidance from your prescriber or pharmacist. If you think you're having a serious reaction, see our emergency resources page.

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