Prescription medicine
Doxepin Brand names: Silenor, Prudoxin, Zonalon; first approved as Sinequan
Doxepin (Sinequan) is a prescription medicine with an FDA approval on record since 1969. FDA's NDC Directory lists it from 49 generic labelers, and pharmacies paid $0.0779 per doxepin 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the doxepin FDA label on DailyMed (effective December 30, 2025, Leading Pharma, LLC); the NDA 16798 record on Drugs@FDA; every doxepin label on DailyMed.
Highlights of the record
FDA label of December 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin Hydrochloride is not approved for use in pediatric patients. (See WARNINGS : Clinical Worsening and Suicide Risk, PRECAUTIONS : Information for Patients, and PRECAUTIONS : Pediatric Use ).
Used for
From the label: indications and usageDoxepin Hydrochloride is recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety.
Forms and strengths
- 3 mg
- 6 mg
- 10 mg
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 150 mg
- 10 mg/ml
- 50 mg/g
Capsule; tablet; film-coated tablet; cream; solution.
On the market
- Earliest approval on file
- September 23, 1969 Sinequan, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 60 first May 13, 1986; 33 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 51 of which 49 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- September 7, 2030 Silenor tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0779 per capsule Doxepin 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest July 25, 2025
- FAERS reports
- 12,554 through July 30, 2026
What is doxepin used for?
From the label: indications and usageDoxepin 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. […]
Conditions named in the indications of doxepin's FDA labels, with every medicine labeled for each:
From other doxepin labelsEczema (atopic dermatitis): INDICATIONS AND USAGE Doxepin hydrochloride cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus (see DOSAGE AND ADMINISTRATION ).
Insomnia: Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
FDA pharmacologic class: Tricyclic Antidepressant.
Source: FDA drug label (DOXEPIN HYDROCHLORIDE), Leading Pharma, LLC, effective December 30, 2025 (SPL set e6a4cb10-1928-4abe-8797-404c9ddc37dd), via openFDA; the full label on DailyMed
What does the patient leaflet for doxepin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about doxepin hydrochloride capsules?D oxepin hydrochloride capsules can cause serious side effects, including: Increased risk of suicidal thoughts and actions. Doxepin hydrochloride capsules and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Doxepin hydrochloride capsules are not for use in children. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your health care provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. Keep all follow-up visits with your health care provider as scheduled. Call your health care provider between visits as needed, especially if you have concerns about symptoms. Call your health care provider or get emergency help right away if you or a family member have any of the following symptoms, especially if they are new, worse, or worry you: suicide attempts acting aggressive, being angry, or violent new or worse depression panic attacks new or worse irritability an extreme increase in activity or talking (mania) thoughts about suicide or dying acting on dangerous impulses new or worse anxiety feeling very agitated or restless trouble sleeping other unusual changes in behavior or mood See “What are the possible side effects of doxepin hydrochloride capsules?” for more information about side effects.
From the patient leaflet: What should I avoid while taking doxepin hydrochloride capsules?Do not drive a car or another motor vehicle, operate heavy machinery, or do dangerous activities while taking doxepin hydrochloride capsules. Doxepin hydrochloride capsules can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Do not drink alcohol during treatment with doxepin hydrochloride capsules. Drinking alcohol during treatment with doxepin hydrochloride capsules can increase your risk of having serious side effects.
From the patient leaflet: How should I store doxepin hydrochloride capsules?Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep doxepin hydrochloride capsules and all medicines out of the reach of children. General Information about the safe and effective use of doxepin hydrochloride capsules. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take doxepin hydrochloride capsules for a condition for which it was not prescribed. Do not give doxepin hydrochloridecapsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about doxepin hydrochloride capsules that is written for health professionals.
Source: FDA drug label (Doxepin hydrochloride), Ajanta Pharma USA Inc., effective November 17, 2025 (SPL set 1513c98c-e7ef-4009-b932-6757048bb86a), via openFDA; the full label on DailyMed
Is there a generic for doxepin (Sinequan)?
The FDA approved the first generic doxepin on May 13, 1986. 60 generic applications are approved; 33 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists doxepin from 49 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Sinequan capsules; a patent listed only for Silenor tablets runs to September 7, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1969 earliest approval on file
- 1986 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for doxepin (Sinequan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0779 per Doxepin 10 mg capsule, down 9% from $0.0857 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Doxepin 10 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Doxepin 10 mg capsule | Generic | $0.0779 per capsule | $2.34 | -9% |
| Doxepin 10 mg/mL oral conc | Generic | $0.839 per mL | n/a | +107% |
| Doxepin 100 mg capsule | Generic | $0.290 per capsule | $8.70 | +16% |
| Doxepin 25 mg capsule | Generic | $0.142 per capsule | $4.25 | +14% |
| Doxepin 5% cream | Generic | $7.12 per gram | n/a | -9% |
| Doxepin 50 mg capsule | Generic | $0.157 per capsule | $4.71 | +0.2% |
| Doxepin 75 mg capsule | Generic | $0.197 per capsule | $5.90 | -18% |
| Doxepin HCl 3 mg tablet | Generic | $1.33 per tablet | $40.00 | -32% |
| Doxepin HCl 6 mg tablet | Generic | $1.37 per tablet | $41.15 | -37% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has doxepin been recalled?
The FDA's Enforcement Report lists 2 recalls naming doxepin since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 25, 2025 | Class II | Alembic Pharmaceuticals Limited | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; DOXEPIN HCL Capsule, 150 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD46312_7, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the doxepin label say about other medicines?
The doxepin label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name doxepin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cimetidine | drug interactions | Cimetidine SILENOR exposure is doubled with concomitant administration of cimetidine, a nonspecific inhibitor of CYP isozymes. |
| Flecainide | drug interactions | 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). |
| Fluoxetine | drug interactions | 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. |
| Paroxetine | drug interactions | 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. |
| Propafenone | drug interactions | 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). |
| Quinidine | drug interactions | 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). |
| Sertraline | drug interactions | 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. |
Other labels that name doxepin
Source: FDA drug label (DOXEPIN HYDROCHLORIDE), Leading Pharma, LLC, effective December 30, 2025 (SPL set e6a4cb10-1928-4abe-8797-404c9ddc37dd), via openFDA; the full label on DailyMed
What do FAERS reports show for doxepin?
The FDA Adverse Event Reporting System holds 12,554 reports that list doxepin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,171 are coded as a death and 3,572 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as doxepin?
32 other medicines are given the same way (oral) and in the same FDA class as doxepin or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Nortriptyline | Depression | 27 labelers | $0.113 per capsule 10 mg capsule | No current entry |
| Desipramine | Depression | 9 labelers | $0.276 per tablet 75 mg tablet | No current entry |
| Imipramine | Depression | 14 labelers | $0.0698 per tablet 10 mg tablet | No current entry |
| Trimipramine | Depression | 3 labelers | n/a | No current entry |
| Amoxapine | Depression, Anxiety | 2 labelers | n/a | No current entry |
| Amitriptyline and perphenazine | Anxiety | 1 labeler | n/a | No current entry |
| Protriptyline | Depression | 2 labelers | $2.71 per tablet 10 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does doxepin compare with medicines for the same use?
13 side-by-side pages set doxepin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to doxepin
- 32 medicines for the same use
- Other tricyclic antidepressants
- the pharmacologic class, with prices and generics
- Doxepin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other