FDA label
What is doxepin used for?
The FDA-approved uses of doxepin, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Doxepin Hydrochloride is recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety; Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol); Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly); Psychotic d...”
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Doxepin Hydrochloride, capsule
Indications and Usage, quoted from the label by Leading Pharma, LLC (ANDA211619). Cross-references to other label sections are left out.
Doxepin Hydrochloride is recommended for the treatment of:
- Psychoneurotic patients with depression and/or anxiety.
- Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
- Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
- Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin hydrochloride is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride is not recommended for use in children under 12 years of age.
Source: DailyMed label, set id e6a4cb10-1928-4abe-8797-404c9ddc37dd, version 12, effective December 30, 2025. NDC 69315-158, one of 163 listings for this product.
Doxepin, tablet
Indications and Usage, quoted from the label by Ajanta Pharma USA Inc. (ANDA218564). Cross-references to other label sections are left out.
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.
Source: DailyMed label, set id b198ade7-fe78-437e-82b4-693dfe45ab51, version 3, effective June 18, 2026. NDC 27241-280, one of 25 listings for this product.
Questions
What is doxepin used for?
The FDA label says: “Doxepin Hydrochloride is recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety; Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol); Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly); Psychotic d...”
What drug class is doxepin?
FDA lists doxepin in the Tricyclic Antidepressant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.