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Two medicines, side by side

Doxepin vs amitriptyline

Doxepin and amitriptyline are both labeled for depression. Drugs@FDA records approvals of doxepin since 1969 and of amitriptyline since 1961. Pharmacies paid $0.0779 per doxepin 10 mg capsule and $0.03 per amitriptyline HCl 10 mg tablet (NADAC, October 7, 2026).

Check it at the source: the doxepin FDA label on DailyMed (effective December 30, 2025); the amitriptyline FDA label on DailyMed (effective September 8, 2026).

Highlights of the doxepin record

Doxepin (Sinequan) · label of December 30, 2025

Boxed warning

Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.

Used for

From the label: indications

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). […]

On the market

Earliest approval on file
September 23, 1969
Generic labelers
49 labelers
Pharmacy cost
$0.0779 per capsule

Supply and safety

Shortage
No current entry
Recalls
2

Highlights of the amitriptyline record

Amitriptyline (Elavil) · label of September 8, 2026

Boxed warning

Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amitriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.

Used for

From the label: indications

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

On the market

Earliest approval on file
April 7, 1961
Generic labelers
34 labelers
Pharmacy cost
$0.03 per tablet

Supply and safety

Shortage
No current entry
Recalls
2

Source: FDA drug labels via openFDA (Doxepin label of December 30, 2025, Amitriptyline label of September 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do doxepin and amitriptyline differ on the record?

Both are in FDA's class tricyclic antidepressants.

Both labels carry a boxed warning; the records quote them.

Generics: doxepin since 1986; amitriptyline since 1976 (Drugs@FDA).

DoxepinAmitriptyline
Labeled forDepression, Anxiety, Eczema (atopic dermatitis), InsomniaDepression
Pharmacologic classTricyclic AntidepressantTricyclic Antidepressant
How it works (label)n/ain man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system.
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)September 23, 1969April 7, 1961
First generic approvedMay 13, 1986November 16, 1976
Generic labelers (NDC)49 labelers34 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0779 per capsule (Doxepin 10 mg capsule)$0.03 per tablet (Amitriptyline HCl 10 mg tablet)
12-month price change-9%-19%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded22
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)12,55417,441
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What do the labels say about using others of their kind?

Amitriptyline label, warnings

If concomitant use of amitriptyline hydrochloride with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Source: FDA drug labels via openFDA

What next?

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