Two medicines, side by side
Doxepin vs zolpidem
Doxepin and zolpidem are both labeled for insomnia. Drugs@FDA records approvals of doxepin since 1969 and of zolpidem since 1992. Pharmacies paid $0.0779 per doxepin 10 mg capsule and $0.0344 per zolpidem tartrate 5 mg tablet (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 zolpidem a gamma-aminobutyric acid a receptor positive modulator.
Check it at the source: the doxepin FDA label on DailyMed (effective December 30, 2025); the zolpidem FDA label on DailyMed (effective August 15, 2022).
Highlights of the doxepin record
Doxepin (Sinequan) · label of December 30, 2025
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: indicationsDoxepin 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 zolpidem record
Zolpidem (Ambien) · label of August 15, 2022
COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsEdluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. […]
On the market
- Earliest approval on file
- December 16, 1992
- Generic labelers
- 39 labelers
- Pharmacy cost
- $0.0344 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 6
Source: FDA drug labels via openFDA (Doxepin label of December 30, 2025, Zolpidem label of August 15, 2022); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do doxepin and zolpidem differ on the record?
In FDA's classes, doxepin is a tricyclic antidepressant and zolpidem a gamma-aminobutyric acid a receptor positive modulator.
Both labels carry a boxed warning; the records quote them.
Generics: doxepin since 1986; zolpidem since 2007 (Drugs@FDA).
DEA schedule: doxepin none; zolpidem CIV.
| Doxepin | Zolpidem | |
|---|---|---|
| Labeled for | Depression, Anxiety, Eczema (atopic dermatitis), Insomnia | Insomnia |
| Pharmacologic class | Tricyclic Antidepressant | gamma-Aminobutyric Acid A Receptor Positive Modulator, gamma-Aminobutyric Acid-ergic Agonist |
| How it works (label) | n/a | Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α 1 subunit containing GABA A receptors, increasing the … |
| Half-life (label) | n/a | Elimination: When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem elimination half-life was 2.85 hours (range: 1.57-6.73 hr) and 2.65 hours (range: 1.75 to 3.77 hr) … |
| Earliest approval on file (Drugs@FDA) | September 23, 1969 | December 16, 1992 |
| First generic approved | May 13, 1986 | April 23, 2007 |
| Generic labelers (NDC) | 49 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0779 per capsule (Doxepin 10 mg capsule) | $0.0344 per tablet (Zolpidem tartrate 5 mg tablet) |
| 12-month price change | -9% | -0.3% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 2 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 12,554 | 134,363 |
| DEA schedule | none | CIV |
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?
Zolpidem label, drug interactionsCNS-active Drugs CNS Depressants Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1 , 5.2) ].
Source: FDA drug labels via openFDA
What next?
- Alternatives to doxepin
- every medicine labeled for the same conditions