Skip to main content

Two medicines, side by side

Doxepin vs temazepam

Doxepin and temazepam are both labeled for insomnia. Drugs@FDA records approvals of doxepin since 1969 and of temazepam since 1981. Pharmacies paid $0.0779 per doxepin 10 mg capsule and $0.0767 per temazepam 15 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, doxepin is a tricyclic antidepressant and temazepam a benzodiazepine.

Check it at the source: the doxepin FDA label on DailyMed (effective December 30, 2025); the temazepam FDA label on DailyMed (effective June 9, 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 temazepam record

Temazepam (Restoril) · label of June 9, 2026

Boxed warning

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.

Used for

From the label: indications

Restoril ® (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Restoril ® (temazepam) should be used for short periods of time (7 to 10 days). […]

On the market

Earliest approval on file
February 27, 1981
Generic labelers
20 labelers
Pharmacy cost
$0.0767 per capsule

Supply and safety

Shortage
No current entry
Recalls
1

Source: FDA drug labels via openFDA (Doxepin label of December 30, 2025, Temazepam label of June 9, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do doxepin and temazepam differ on the record?

In FDA's classes, doxepin is a tricyclic antidepressant and temazepam a benzodiazepine.

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

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

DEA schedule: doxepin none; temazepam CIV.

DoxepinTemazepam
Labeled forDepression, Anxiety, Eczema (atopic dermatitis), InsomniaInsomnia
Pharmacologic classTricyclic AntidepressantBenzodiazepine
How it works (label)n/an/a
Half-life (label)n/aThe blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the terminal half-life from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study population and …
Earliest approval on file (Drugs@FDA)September 23, 1969February 27, 1981
First generic approvedMay 13, 1986July 10, 1986
Generic labelers (NDC)49 labelers20 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0779 per capsule (Doxepin 10 mg capsule)$0.0767 per capsule (Temazepam 15 mg capsule)
12-month price change-9%+0.5%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded21
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)12,55437,475
DEA schedulenoneCIV

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?

Temazepam label, drug interactions

The benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.

Source: FDA drug labels via openFDA

What next?

Alternatives to doxepin
every medicine labeled for the same conditions