Doxepin: uses, dosing, side effects & brands
Doxepin is a tricyclic antidepressant sold in the U.S. under 3 brand and generic names, for anxiety disorders, depressive disorder and atopic dermatitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Tricyclic Antidepressant
- Treats (across its forms)
- Anxiety Disorders, Depressive Disorder and Atopic Dermatitis
- Available as
- Capsule · Topical · Solution · Tablet
- Sold as
- 3 products — Doxepin Hydrochloride, Zonalon and Sinequan
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 8 to 24 hours (average about 17 hours)
- What the pharmacy pays
- about $5 for a 30-count supply — not your price
Get treated for Doxepin conditions online
Licensed online providers — consult & get prescribed if eligible.
Advertising disclosure: We may earn a commission, at no extra cost to you. This never affects our ratings. Details
How Zonalon is dosed
From the FDA label for Zonalon (application NDA020126). Other doxepin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
A thin film of Zonalon ® Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of Zonalon ® Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of Zonalon ® Cream for longer than 8 days may result in an increased likelihood of contact sensitization. The risk for sedation may increase with greater body surface area application of Zonalon ® Cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying Zonalon ® Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see WARNINGS section) affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug. Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with Zonalon ® Cream.
Everything below is the FDA label for Zonalon (topical). Doxepin is also sold as capsule, solution and tablet, and those are different medicines to take — follow the label for the one you were prescribed.
Zonalon side effects
Controlled Clinical Trials Systemic Adverse Effects In controlled clinical trials of patients treated with Zonalon ® Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with Zonalon ® Cream compared to 7 of 334 (2%) of patients treated with vehicle cream. Drowsiness resulted in the premature discontinuation of the drug in approximately 5% of patients treated with Zonalon ® Cream in controlled clinical trials. Local Site Adverse Effects In controlled clinical trials of patients treated with Zonalon ® Cream, the most common local site adverse event reported was burning and/or stinging at the site of application. These occurred in 76 of 330 (23%) of patients treated with Zonalon ® Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with Zonalon ® Cream withdrew from the study because of the burning and/or stinging. The table below presents the adverse events reported at an incidence of ≥ 1% in either Zonalon ® or vehicle cream treatment groups during the trials: Adverse Event Zonalon ® N=330 Vehicle N=334 Burning/Stinging 76 (23.0%) 54 (16.2%) Drowsiness 71 (21.5%) 7 (2.1%) Dry Mouth Includes reports…
Who shouldn’t take Zonalon
Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical Zonalon ® Cream application, the use of Zonalon ® Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention. Zonalon ® Cream is contraindicated in individuals who have shown previous sensitivity to any of its components.
Zonalon drug interactions
Studies have not been performed examining drug interactions with Zonalon ® Cream. However, since plasma levels of doxepin following topical application of Zonalon ® Cream can reach levels obtained with oral doxepin HCl therapy, the following drug interactions are possible following topical Zonalon ® Cream application: Drugs Metabolized by P450 2D6 The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7-10% of Caucasians are so-called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA). In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dosage regimen of a TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary). Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6. MAO Inhibitors Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Therefore, MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with Zonalon ® Cream. The exact length of time may vary and is dependent upon the particular MAO inhibitor being used, the length of time it has been administered, and the dosage involved. Cimetidine Serious anticholinergic symptoms (i.e., severe dry mouth, urinary retention and blurred vision) have been associated with elevations in the serum levels of tricyclic antidepressants when cimetidine therapy is initiated. Additionally, higher than expected tricyclic antidepressant levels have been observed when they are begun in patients already taking cimetidine. Alcohol Alcohol ingestion may exacerbate the potential sedative effects of Zonalon ® Cream. This is especially important in patients who may use alcohol excessively. Tolazamide A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 gm/day) 11 days after the addition of oral doxepin (75 mg/day).
Every doxepin product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $5 | View → | |
| 2 | 66/100 | Prescription | Topical | Generic | $5 | View → | |
| 3 | 64/100 | Prescription | Capsule | Generic | $5 | View → |
What doxepin pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Doxepin recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long doxepin keeps
No doxepin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does doxepin expire? The in-use limits and storage rules from its labelsDoxepin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for doxepin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause of its sedating potential, active metabolite, presence in infant serum, two reports of adverse effects in breastfed infants, and only one report of use without apparent adverse reactions, doxepin is a poor choice and other agents are preferred, especially while nursing a newborn or preterm infant. A safety scoring system finds doxepin to be not recommended during breastfeeding.
National Institute of Child Health and Human Development, record revised August 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about doxepin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,071 reports naming doxepin, and the FDA flagged 67% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dizziness164 reports
- insomnia163 reports
- fatigue154 reports
- fall152 reports
- anxiety147 reports
- pruritus120 reports
- memory impairment116 reports
- headache111 reports
Read these as a signal, not a rate. A report does not mean doxepin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
How long doxepin stays in your system
The elimination half-life of doxepin is about 8 to 24 hours (average about 17 hours). The label's number is for doxepin itself. Its main active metabolite, nordoxepin (N-desmethyldoxepin), lasts far longer — a half-life of 33 to 80 hours (mean 51 hours) — so drug activity persists well beyond what the parent half-life suggests, and steady state takes days rather than hours. The low-dose insomnia tablet (Silenor 3 mg/6 mg) is not a different-duration product: its label gives a terminal half-life of 15.3 hours for doxepin and 31 hours for nordoxepin, essentially the same range. There is no extended-release oral doxepin. Neither label gives a separate half-life figure for older adults, but both warn that doxepin can cause confusion and oversedation in geriatric patients and that starting doses should be lower. Liver impairment matters more than kidney impairment: 55%–87% of an oral dose is cleared by first-pass hepatic metabolism, and the label states patients with hepatic impairment may have greater systemic exposure; renal impairment has not been studied, and because little drug leaves in the urine unchanged, the Silenor label says renal impairment would not be expected to change doxepin levels much. Exposure is also higher in CYP2C19 or CYP2D6 poor metabolizers and with inhibitors such as cimetidine, which roughly doubled doxepin Cmax and AUC.
Doxepin Hydrochloride Capsules — FDA Prescribing Information, Section 12.3 Pharmacokinetics (Mylan Pharmaceuticals, DailyMed, updated 2025-10-15) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Zonalon?
Zonalon (Doxepin Hydrochloride) is a tricyclic antidepressant used to treat Anxiety Disorders, Depressive Disorder, Atopic Dermatitis, Pain.
What kind of drug is doxepin?
The FDA classifies doxepin as a tricyclic antidepressant. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does doxepin stay in your system?
The elimination half-life of doxepin is about 8 to 24 hours (average about 17 hours) — that is how long the body takes to clear half of a dose. The label's number is for doxepin itself. Its main active metabolite, nordoxepin (N-desmethyldoxepin), lasts far longer — a half-life of 33 to 80 hours (mean 51 hours) — so drug activity persists well beyond what the parent half-life suggests, and steady state takes days rather than hours. The low-dose insomnia tablet (Silenor 3 mg/6 mg) is not a different-duration product: its label gives a terminal half-life of 15.3 hours for doxepin and 31 hours for nordoxepin, essentially the same range. There is no extended-release oral doxepin. Neither label gives a separate half-life figure for older adults, but both warn that doxepin can cause confusion and oversedation in geriatric patients and that starting doses should be lower. Liver impairment matters more than kidney impairment: 55%–87% of an oral dose is cleared by first-pass hepatic metabolism, and the label states patients with hepatic impairment may have greater systemic exposure; renal impairment has not been studied, and because little drug leaves in the urine unchanged, the Silenor label says renal impairment would not be expected to change doxepin levels much. Exposure is also higher in CYP2C19 or CYP2D6 poor metabolizers and with inhibitors such as cimetidine, which roughly doubled doxepin Cmax and AUC. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take doxepin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run doxepin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is doxepin sold under?
We track 3 doxepin-containing products in the U.S.: Doxepin Hydrochloride, Zonalon and Sinequan. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does doxepin come in?
Across the brands we track, doxepin is currently marketed as capsule, topical, solution and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic doxepin?
Yes. Our catalog lists 1 generic doxepin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has doxepin been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions doxepin. The most recent: Doxepin Hydrochloride Capsules (Jul 25, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Doxepin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/doxepin
- MLA
- “Doxepin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/doxepin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for doxepin on DailyMed (NIH) ↗.