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Doxepin

Doxepin is a tricyclic antidepressant used, depending on the product, for depression and anxiety, major depressive disorder, trouble staying asleep (insomnia), or itching from certain skin conditions.

Brand names PrudoxinZonalonSilenor
Drug class Tricyclic Antidepressant
Rx Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 105 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026 🚨Recall on record
Other forms & routes:
Topical
Doxepin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Doxepin is an older tricyclic antidepressant (on the market since about 1969, available as a generic) that treats different things by form, with capsules and liquid for depression and anxiety (now rarely a first choice), a low-strength tablet for staying asleep, and a cream for short-term itching. Drowsiness is the main effect, since it strongly blocks histamine (a wakefulness signal), and antidepressant strengths add dry mouth and constipation, while the sleep tablet is usually gentler. Its boxed warning covers suicidal thoughts and behaviors in children, teens and young adults, so watch mood early and after dose changes. Never combine it with an MAOI (an older antidepressant type), and avoid alcohol.

Clinical pearls

  • Take the sleep tablet within 30 minutes of bedtime, and not within 3 hours of a meal.
  • Use the cream no more than 8 days and on limited areas, because more skin contact means more drowsiness.
  • Mention doxepin before starting an opioid, triptan, SSRI antidepressant or St. John's Wort, since combining them risks serotonin syndrome (agitation, fever, tremor).
  • Do not stop the antidepressant forms suddenly, because your prescriber should lower the dose gradually.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Antidepressants like doxepin can increase suicidal thoughts and behaviors in children, teens and young adults. This was seen in short-term studies.

Everyone taking an antidepressant should be watched for worsening depression or new suicidal thoughts, especially early on and after dose changes. Family and caregivers should report behavior changes to the prescriber. Doxepin capsules are not approved for children.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Tablet, Topical cream, ointment or gel +1
Earliest FDA record1969
Companies listing it with the FDA47
FDA label last updatedJan 8, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient Information Guide A plain-language walkthrough of Doxepin, written from its FDA label.

What Doxepin Is Used For

▾

Doxepin is used for several conditions, depending on the product.

  • Doxepin Hydrochloride capsules: depression and/or anxiety in psychoneurotic patients.
  • Doxepin Hydrochloride capsules: depression and/or anxiety linked to alcoholism (not to be taken with alcohol) or organic disease.
  • Doxepin Hydrochloride capsules: psychotic depressive disorders with anxiety, including involutional depression and manic-depressive disorders.
  • Doxepin Hydrochloride oral solution: major depressive disorder in adults.
  • Silenor and doxepin tablets: insomnia with difficulty staying asleep.
  • Doxepin Hydrochloride cream, Prudoxin and Zonalon: short-term (up to 8 days) management of moderate itching in adults with atopic dermatitis or lichen simplex chronicus.

How Doxepin Works

▾

How doxepin helps sleep is not fully understood. It may work by blocking the H1 (histamine) receptor, which helps keep you awake. Doxepin binds very strongly to this receptor.

Doxepin Dosage

▾

Dosing depends on the product, so follow your prescriber and label.

  • Capsules and oral solution: taken by mouth, once daily or in divided doses. Stop gradually.
  • Sleep tablets (Silenor and others): once daily within 30 minutes of bedtime, and not within 3 hours of a meal.
  • Cream (Prudoxin, Zonalon): a thin film four times a day, 3 to 4 hours apart, for no more than 8 days.

Dosing details from the FDA-approved label

From the Doxepin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Oral doxepin hydrochloride (capsules and oral solution) - recommended dosage
    • Starting oral dosage is 25 mg three times daily or 75 mg once daily
    • Target total dosage range is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses)
    • Maximum: 100 mg three times daily
    • Screen for personal or family history of bipolar disorder, mania, or hypomania before starting; reduce dosage if anticholinergic effects develop; reduce dosage based on doxepin plasma concentrations with strong CYP2D6 inhibitors and in known CYP2D6 and CYP2C19 poor metabolizers
  • Doxepin Hydrochloride Cream, 5% (also Prudoxin and Zonalon creams) - topical
    • A thin film applied four times each day with at least a 3 to 4 hour interval between applications
    • No safety and effectiveness data for use greater than 8 days; avoid occlusive dressings; drowsiness is more common when applied to over 10% of body surface area
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 ) • Recommended starting oral dosage is 25 mg three times daily or 75 mg once daily. ( 2.2 ) • Recommended target total dosage range is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). ( 2.2 ) • Maximum recommended dosage is 100 mg three times daily. ( 2.2 ) • Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules. ( 2.3 ) • See the Full Prescribing Information for dosage modifications intended to reduce the risk of anticholinergic effects, for strong CYP2D6 inhibitors, and in known CYP2D6 and CYP2C19 poor metabolizers. ( 2.4 , 2.5 , 2.6 ). • When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued. ( 2.7 ) 2.1 Screen for Bipolar Disorder Prior to Starting doxepin hydrochloride capsules Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5) ]. 2.2 Recommended Dosage The recommended starting oral dosage for doxepin hydrochloride capsules are 25 mg three times daily or 75 mg once daily. The recommended target total oral dosage range for doxepin hydrochloride capsules are between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). The maximum recommended oral dosage for doxepin hydrochloride capsules are 100 mg three times daily. 2.3 Switching Patients to or from a Monoamine Oxidase Inhibitor Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules [see Contraindications (4 ), Warnings and Precautions ( 5.2) , and Drug Interactions (7) ]. Wait at least 14 days after discontinuation of doxepin hydrochloride capsules before initiating therapy with an MAOI [see Contraindications ( 4.4) , Warnings and Precautions ( 5.2 ), and Drug Interactions (7) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Doxepin Side Effects

▾

Common side effects seen with doxepin include:

Common side effects

  • Sleepiness or sedation
  • Nausea
  • Upper respiratory tract infection (cold-like symptoms)
  • Dizziness
  • Dry mouth, blurred vision and constipation (anticholinergic effects)
  • Drowsiness with the cream, more likely when used over large areas of skin

When to get medical help

  • Call your doctor right away if you have new or worsening depression, suicidal thoughts or unusual changes in behavior.
  • Seek urgent help for possible serotonin syndrome: confusion, agitation, hallucinations, fast heartbeat, fever, sweating, tremor, stiff muscles, seizures, nausea, vomiting or diarrhea.
  • Get help for eye pain or symptoms of an angle-closure glaucoma attack.
  • Tell your doctor about seizures, or mania or psychosis symptoms that appear or worsen.
  • Do not drive or use dangerous machinery until you know how doxepin affects you.
  • In suspected overdose, call poison control or emergency services immediately.

Doxepin Warnings and Precautions

▾
  • Suicidal thoughts and behaviors: boxed warning, especially in children, teens and young adults.
  • Serotonin syndrome: risk rises with other serotonergic drugs.
  • Angle-closure glaucoma: avoid with untreated narrow angles.
  • Sedation: avoid driving or dangerous machinery. Alcohol effects may be stronger.
  • Mania, seizures and psychosis: can be triggered or worsened in people with bipolar disorder, seizure history or schizophrenia.
  • Cream: do not use beyond 8 days.

Doxepin Interactions

▾

These can clash with doxepin:

  • MAOIs, including linezolid and IV methylene blue: serotonin syndrome risk. Never combine.
  • Other serotonergic drugs: raise serotonin syndrome risk.
  • Alcohol and CNS depressants: more sedation.
  • Strong CYP2D6 inhibitors and cimetidine: raise doxepin levels.
  • Carbamazepine: lowers doxepin levels.
  • Tolazamide: risk of severe low blood sugar.

Interactions listed in the FDA-approved label

From the Doxepin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Monoamine oxidase inhibitors (MAOIs), including linezolid or intravenous methylene blue: Concomitant use increases the risk of serotonin syndrome. Contraindicated; do not use within 14 days of discontinuing an MAOI, or use an MAOI within 14 days of discontinuing doxepin; starting doxepin in a patient being treated with an MAOI is contraindicated
  • Other serotonergic drugs (besides MAOIs): Concomitant use increases the risk of serotonin syndrome. Monitor for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases; if it occurs, consider discontinuing doxepin and/or the serotonergic drugs
  • Strong CYP2D6 inhibitors: May increase doxepin exposure, which may increase the risk of doxepin-related adverse reactions. Monitor doxepin plasma concentrations and reduce the doxepin dosage or the strong CYP2D6 inhibitor as appropriate
  • Carbamazepine: Decreases doxepin exposure, which could lead to reduced treatment effect. Monitor doxepin plasma concentrations and consider increasing the doxepin dosage
  • Cimetidine: May increase doxepin exposure, which may increase the risk of anticholinergic effects (e.g., dry mouth, blurred vision, constipation). Monitor doxepin plasma concentrations and consider reducing the doxepin dosage
  • Alcohol: Doxepin may potentiate the sedative effects of alcohol. Avoid concomitant use with alcohol
  • CNS depressants: The sedative effects of the CNS depressant may be potentiated. Dosage reduction of doxepin and/or the CNS depressant may be needed based on clinical response and tolerability
  • Tolazamide: Doxepin may cause severe hypoglycemia when used with tolazamide. Monitor glucose levels and reduce the doxepin dosage as appropriate
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 2 describe the clinically significant drug interactions of doxepin hydrochloride capsules with other drugs or classes. Table 2: Clinically Significant Drug Interactions with Doxepin Hydrochloride Capsules Monoamine Oxidase Inhibitors Prevention or Management Doxepin hydrochloride capsules are contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue. The use of doxepin hydrochloride capsules within 14 days of discontinuation of an MAOI or the use of MAOI within 14 days of discontinuation of doxepin hydrochloride capsules is contraindicated . Starting doxepin hydrochloride capsules in a patient who is being treated with an MAOI is contraindicated . Clinical Effect(s) Concomitant use of doxepin hydrochloride capsules and MAOIs increases the risk of serotonin syndrome [ Warnings and Precautions (5.2) ] . Other Serotonergic Drugs (Besides MAOIs) Prevention or Management Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of doxepin hydrochloride capsules and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ]. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride capsules with other serotonergic drugs increases the risk of serotonin syndrome [see Warnings and Precautions (5.2) ]. Strong CYP2D6 Inhibitors Prevention or Management Monitor doxepin plasma concentrations and reduce the doxepin hydrochloride capsules dosage or the strong CYP2D6 inhibitor as appropriate [see Dosage and Administration (2.5) ].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Doxepin against a supplement or herb →

Before Taking Doxepin

▾
  • Allergy to doxepin or other dibenzoxepines.
  • Current or recent (within 2 weeks) MAOI use.
  • Untreated narrow-angle glaucoma or severe urinary retention.
  • Bipolar disorder, mania, schizophrenia or seizures.
  • Pregnancy: newborns exposed late in the third trimester may have complications.
  • Breastfeeding is not recommended.
  • Children: not approved (capsules) and not evaluated.
  • Older adults: may become confused or oversedated.
  • Liver problems: levels may run higher.
  • Sleep apnea: not studied, and usually not recommended in severe cases.

Doxepin Overdose

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Too much doxepin can cause confusion, hallucinations, drowsiness, seizures, dangerous heart rhythms, very low blood pressure, coma and other serious effects. Call poison control or emergency services right away. Overdose needs hospital care with heart monitoring.

What Doxepin Does in the Body

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Doxepin binds very strongly to the H1 (histamine) receptor. In a study of healthy people, doses up to 50 mg a day had no effect on the heart’s QT interval or other ECG measures.

How Your Body Processes Doxepin

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After a dose by mouth, doxepin peaks in the blood at about 3.5 hours when taken fasted. A high-fat meal raises the amount absorbed and delays the peak, which is why sleep tablets should not be taken within 3 hours of a meal. The liver breaks it down mainly using CYP2C19 and CYP2D6 enzymes into nordoxepin. Little leaves the body unchanged in urine. Half-life is about 15 hours for doxepin and 31 hours for nordoxepin.

How to Store Doxepin

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Store at 20°C to 25°C (68°F to 77°F) , protected from light. Dispense in a tight, light resistant container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Doxepin: Pharmacist Answers to Common Questions

Quick, plain-English answers to the questions patients ask most about Doxepin — the kind of thing our pharmacy team would talk through with you at the counter.

What is doxepin used for?

▾
It depends on the product. Capsules treat depression and anxiety, the oral solution treats major depressive disorder in adults, tablets such as Silenor treat trouble staying asleep, and the cream eases itching in adults with atopic dermatitis or lichen simplex chronicus.

When should I take the sleep tablet?

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Take it within 30 minutes of bedtime. Do not take it within 3 hours of a meal. A meal can slow absorption and may cause more next-day effects.

What side effects should I expect?

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Sleepiness is the most common, along with nausea, cold-like symptoms and dizziness. Dry mouth, blurred vision and constipation can also happen. Call me or your doctor if anything bothers you or doesn’t settle.

Can I drink alcohol with it?

▾
Avoid it. Doxepin can make alcohol’s sedating effects stronger. Also avoid driving until you know how it affects you.

What should I watch for with mood?

▾
Antidepressants can raise suicidal thoughts in children, teens and young adults, especially early on or after dose changes. Tell your doctor right away about new or worsening mood or behavior changes. Family can help watch too.

Is it safe in pregnancy or breastfeeding?

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Use late in the third trimester may cause breathing, feeding and other problems in newborns. Breastfeeding is not recommended because babies can become overly sedated. Talk with your prescriber before using it if you are pregnant or nursing.

Is Doxepin available over the counter?

▾
No. Doxepin is a prescription medicine: every Doxepin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Doxepin first available?

▾
The earliest FDA record we hold for Doxepin is from 1969: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Doxepin was first used.

Who makes Doxepin?

▾
47 companies currently list Doxepin products in the FDA's NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc., NorthStar RxLLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Doxepin on HelloPharmacist

🌿Drug & Supplement CheckerDoxepin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Doxepin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Doxepin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Doxepin Forms and Strengths (How It Comes)

Doxepin is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Doxepin inactive ingredients by manufacturer.

Capsule

By mouth
How this form is used
What it may be used for
  • Doxepin Hydrochloride capsules are used for depression and/or anxiety, including when linked to alcoholism or organic disease, and psychotic depressive disorders with anxiety.
Important instructions
  • Doxepin Hydrochloride capsules may be taken as divided doses or once a day, and a once-daily dose may be taken at bedtime.
  • Doxepin Hydrochloride capsules should not be started until at least 14 days after stopping an MAOI.
Available strengths 6 strengths
10 mg 25 mg 50 mg 75 mg 100 mg 150 mg
293 FDA-listed product records ⓘ

Tablet

By mouth
Brands Silenor
How this form is used
What it may be used for
  • Silenor and doxepin tablets are used for insomnia with difficulty staying asleep.
Important instructions
  • Silenor should be taken within 30 minutes of bedtime.
  • Silenor should not be taken within 3 hours of a meal.
  • Silenor is taken once daily, and older adults start at a lower dose.
Available strengths 2 strengths
3 mg 6 mg
67 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Prudoxin Zonalon
How this form is used
What it may be used for
  • Prudoxin and Zonalon creams are used for short-term (up to 8 days) management of moderate itching in adults with atopic dermatitis or lichen simplex chronicus.
Important instructions
  • Zonalon cream is applied as a thin film four times a day, 3 to 4 hours apart.
  • Prudoxin cream should not be used longer than 8 days.
  • Prudoxin cream over more than 10% of body surface area makes drowsiness more likely.
Available strengths 1 strength
50 mg/g
6 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Doxepin Hydrochloride oral solution is used for major depressive disorder (MDD) in adults.
Important instructions
  • Doxepin Hydrochloride oral solution is taken by mouth once daily or in divided doses, as directed.
  • Doxepin Hydrochloride oral solution should be reduced gradually when stopped.
Available strengths 1 strength
10 mg/mL
4 FDA-listed product records ⓘ

Doxepin on the U.S. Market: Products, Makers and Brands

How Doxepin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

47 companies list 205 Doxepin product records with the FDA, mostly as capsule, tablet, topical cream, ointment or gel; the earliest marketing or approval year on record is 1969. Brand names on the directory include Prudoxin, Zonalon, Silenor; the rest are generics.

4
Dose forms ⓘ
47
Labelers (makers, repackagers, distributors)
6
Brand names
205
FDA-listed product records ⓘ
1969
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (9) · Unfinished tablet (2) · Unfinished tablet, film coated (2) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack9%
Remedyrepack Inc.5%
NorthStar RxLLC4%
Mylan Pharmaceuticals Inc.4%
Ajanta Pharma USA Inc.3%
Aurobindo Pharma Limited3%
Other makers70%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How Widely Doxepin Is Used (Medicaid Data)

A general measure of how commonly Doxepin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Doxepin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

628,470
Medicaid prescriptions filled (Q1–Q4 2025)
$30.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Doxepin prescribed? Of the 1,603 medications we measure, Doxepin ranks #233 by Medicaid prescriptions — more than 85% of them.

Where Doxepin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #233 of 1,603
#228 Rivaroxaban 655,610 Rx #229 Polymyxin B and Trimet... 651,823 Rx #230 Magnesium Oxide 648,844 Rx #231 Alendronate 645,853 Rx #232 Glimepiride 630,394 Rx #233 Doxepin (Insomnia) 628,470 Rx #234 Doxepin (Depression, A... 628,470 Rx #235 Doxepin 628,470 Rx #236 Ropinirole 626,420 Rx #237 Valsartan 609,824 Rx #238 Testosterone Injection 605,127 Rx

Utilization by Doxepin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral capsule is the most-dispensed Doxepin product — about 30% of these Medicaid prescriptions.

doxepin 10 MG Oral Capsule Most dispensed

189,409 Medicaid prescriptions (Q1–Q4 2025) 30% of Doxepin prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 16 of 95 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000048

doxepin 25 MG Oral Capsule

127,554 Medicaid prescriptions (Q1–Q4 2025) 20% of Doxepin prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 14 of 113 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000070

doxepin 50 MG Oral Capsule

108,904 Medicaid prescriptions (Q1–Q4 2025) 17% of Doxepin prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 14 of 82 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000076

doxepin 100 MG Oral Capsule

67,651 Medicaid prescriptions (Q1–Q4 2025) 11% of Doxepin prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 13 of 52 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000058

doxepin hydrochloride 50 MG/ML Topical Cream

36,950 Medicaid prescriptions (Q1–Q4 2025) 6% of Doxepin prescriptions shown $19.6M gross reimbursement (before rebates) ≈ $530 per prescription (gross)

Summed across the 6 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000091

doxepin 150 MG Oral Capsule

29,510 Medicaid prescriptions (Q1–Q4 2025) 5% of Doxepin prescriptions shown $823,737 gross reimbursement (before rebates) ≈ $28 per prescription (gross)

Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000064

doxepin 75 MG Oral Capsule

27,128 Medicaid prescriptions (Q1–Q4 2025) 4% of Doxepin prescriptions shown $500,793 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 12 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000097

doxepin 10 MG/ML Oral Solution

14,180 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin prescriptions shown $526,403 gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000054

doxepin 3 MG Oral Tablet

13,865 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $97 per prescription (gross)

Summed across the 8 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966787

doxepin 6 MG Oral Tablet

13,319 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $94 per prescription (gross)

Summed across the 8 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966793

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Doxepin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 97 of 501 listed Doxepin NDCs with Medicaid activity.

Compare Doxepin Products

A representative set of FDA-listed product records for Doxepin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 205 products — FDA National Drug Code Directory. See every product, package size and price: browse all 205 Doxepin NDCs →

Doxepin Side Effects Reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Doxepin — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Doxepin are toxicity to various agents, completed suicide, fatigue; about 69% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

12,554
Reports mentioning it
69%
Reported as serious
12
Distinct effects shown
Most reported effects
Toxicity To Various Agents
988
Completed Suicide
827
Fatigue
793
Pain
755
Nausea
679
Headache
642
Insomnia
622
Pruritus
605
Dizziness
597
Anxiety
571
Age groups
Adult · 1,586Elderly · 638Child · 31Neonate · 21Adolescent · 21Infant · 5

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Doxepin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Doxepin FDA Approval History

How Doxepin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Doxepin was first approved by the FDA in 1969 (Brand: SINEQUAN · Pfizer); the first generic version was approved in 1986. It remains available in U.S. pharmacies today.

1969
Brand approved
Brand: SINEQUAN · Pfizer
1986
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Doxepin Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Doxepin recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jul 25, 2025 · Alembic Pharmaceuticals Limited
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
  • Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc.,… Lots: Lot: 2305015142, Exp. Date: 9/30/2025 FDA record D-0566-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Doxepin RxCUI 3638 4 dose forms · 10 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 371962 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 1000048 25 MG RxCUI 1000070 50 MG RxCUI 1000076 75 MG RxCUI 1000097 100 MG RxCUI 1000058 150 MG RxCUI 1000064
  2. Dose form (SCDF) Oral Solution RxCUI 379135 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 1000054
  3. Dose form (SCDF) Oral Tablet RxCUI 375040 In current FDA listings
    Clinical drug / strength (SCD) 3 MG RxCUI 966787 6 MG RxCUI 966793
  4. Dose form (SCDF) Topical Cream RxCUI 377691 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 50 MG/ML RxCUI 1000091

Look up RxCUI 3638 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Doxepin Costs Pharmacies (NADAC Benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 10 mg $0.078 per capsule NDC details & price history
Capsule · Oral 25 mg $0.142 per capsule NDC details & price history
Capsule · Oral 50 mg $0.157 per capsule NDC details & price history
Capsule · Oral 100 mg $0.290 per capsule NDC details & price history
Capsule · Oral 75 mg $0.197 per capsule NDC details & price history
Capsule · Oral 150 mg $0.510 per capsule NDC details & price history
Tablet · Oral 6 mg $1.37 per tablet NDC details & price history
Tablet · Oral 3 mg $1.33 per tablet NDC details & price history
Tablet, Film Coated · Oral 6 mg $1.37 per tablet NDC details & price history
Tablet, Film Coated · Oral 3 mg $1.33 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Doxepin Brand Names

Doxepin is sold under 3 brand names in the FDA directory — Prudoxin, Zonalon, Silenor. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Prudoxin Zonalon Silenor

Who Makes Doxepin: Manufacturers and Labelers

47 companies list Doxepin products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Remedyrepack Inc., NorthStar RxLLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 19 Remedyrepack Inc. 11 NorthStar RxLLC 9 Mylan Pharmaceuticals Inc. 8 Ajanta Pharma USA Inc. 7 Aurobindo Pharma Limited 7 Novadoz Pharmaceuticals LLC 7 Amneal Pharmaceuticals NY LLC 6 Direct_Rx 6 Leading Pharma, LLC 6 Alembic Pharmaceuticals Inc. 5 Alembic Pharmaceuticals Limited 5 Chartwell RX, LLC 5 Contract Pharmacal Corp. 5 Epic Pharma, LLC 5 First Nation Group, LLC 5 Florida Pharmaceutical Products, LLC 5 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 5 Lifestar Pharma LLC 5 PD-Rx Pharmaceuticals, Inc. 5 Puracap Laboratories Llc Dba Blu Pharmaceuticals 5 Proficient Rx LP 5 Rising Pharma Holdings, Inc. 5 A-S Medication Solutions 4

…and 23 more on the FDA NDC directory.

Doxepin Drug Class (RxNorm)

Doxepin belongs to the Tricyclic Antidepressant class.

Pharmacologic class Tricyclic Antidepressant
Drug family (ATC) Other antipruritics, Non-selective monoamine reuptake inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for This Doxepin Page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 8, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Doxepin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Doxepin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
105
Finished products in the current FDA directory
205
Companies listing them (makers, repackagers, distributors)
47
FDA labeler codes behind them ⓘ
50
Linked representative label ⓘ
Viona Pharmaceuticals Inc
Linked label effective
Jan 8, 2025
Composite sections available
27
Linked SPL Set ID
3377541d-db46-4fd9-9a4b-faa5f6108e67
Linked SPL Document ID
d569143c-aee2-4e03-988d-1ef10950e7ce
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Viona Pharmaceuticals Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →