FDA-filed SPL labeling · retrieved through openFDA

Doxepin (Depression, Anxiety)

Doxepin is a prescription sleep aid used to treat insomnia when the main problem is waking up during the night or early in the morning.

Brand names Sinequan CapsulesSinequan Concentrated SolutionPrudoxinZonalonSilenor
Drug class Tricyclic Antidepressant
Rx Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set 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 →

At a glance
Linked label effectiveJan 8, 2025
AvailabilityRx
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
💊
HelloPharmacist Editorial Team Bottom Line
Doxepin (for sleep) is a low-dose option for people who wake up and can't get back to sleep — it works by calming histamine activity in the brain. Take it within 30 minutes of bedtime, on an empty stomach, and never with alcohol or other sleep aids. It can cause morning grogginess and, rarely, complex sleep behaviors, so talk openly with your prescriber if anything feels off.

📖 Doxepin (Depression, Anxiety): Patient Information Guide

A plain-language walkthrough of Doxepin (Depression, Anxiety) — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Doxepin tablets are prescribed specifically for insomnia related to difficulty staying asleep.

  • Waking in the middle of the night and struggling to fall back asleep
  • Waking too early in the morning before you feel rested
⚙️How it works

Doxepin is thought to promote sleep by blocking the H1 histamine receptor in the brain. Histamine is a chemical that helps keep you alert; by blocking it very potently, doxepin quiets that wake-promoting signal and helps you stay asleep through the night.

The exact mechanism isn't fully confirmed, but doxepin's extremely tight grip on this receptor — even at a low dose — appears to be key to its sleep-maintaining effect.

💊How it's taken

Doxepin is taken once nightly by mouth, within 30 minutes of bedtime. Older adults typically start at a lower dose than younger adults. The total daily dose should not exceed what your prescriber has ordered.

  • Take it on an empty stomach — eating within 3 hours of your dose slows absorption and can worsen next-morning drowsiness
  • Do not take it if you can't get a full night of sleep
  • Follow your prescriber's exact instructions; do not adjust your own dose
🤒Side effects — in detail

The most common side effects seen in clinical trials were:

  • Somnolence or sedation — feeling very drowsy or hard to wake
  • Nausea
  • Upper respiratory tract infection

More serious reactions — like complex sleep behaviors (sleep-driving, sleep-eating) or worsening depression — are less common but require you to contact your doctor right away.

⚠️Warnings & precautions
  • Complex sleep behaviors: Some people drive, eat, make calls, or do other things while asleep and remember nothing. Risk is higher with alcohol or other sedating drugs. Stop doxepin and call your doctor if this happens.
  • Next-day drowsiness: Doxepin can impair alertness and coordination. Don't drive or use heavy machinery after taking it.
  • Depression and suicidal thinking: Worsening mood or thoughts of self-harm can occur. Keep close contact with your prescriber; only a small supply should be kept at home at any time.
  • If sleep doesn't improve in 7–10 days: Talk to your doctor — there may be an underlying condition that needs to be addressed.
  • Severe sleep apnea: Doxepin is generally not recommended if you have this condition.
🔀What it interacts with

Doxepin can interact with several medications and substances — always tell your pharmacist and prescriber everything you take:

  • MAO inhibitors (MAOIs): A dangerous, potentially fatal combination. Do not combine; wait at least two weeks after stopping an MAOI.
  • Alcohol: Greatly increases sedation and the risk of sleep-driving and other complex behaviors. Avoid completely.
  • Cimetidine (heartburn medication): Roughly doubles doxepin levels in the blood, requiring a lower dose of doxepin.
  • Other CNS depressants (prescription sleep aids, opioids, anti-anxiety medications): Compound drowsiness; dose adjustments may be needed.
  • Sedating antihistamines (found in many OTC cold/allergy products): Add to sedation; use with caution.
  • Tolazamide (a diabetes drug): A case of severe low blood sugar has been reported when used with doxepin.
  • CYP2C19 and CYP2D6 inhibitors (certain antidepressants, antifungals, and other drugs): May increase doxepin levels; check with your pharmacist.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take if you have untreated narrow angle glaucoma (a serious type of elevated eye pressure) or severe urinary retention (inability to empty your bladder)
  • Do not take if you have used a monoamine oxidase inhibitor (MAOI) in the past two weeks
  • Do not take if you are allergic to doxepin or related compounds (dibenzoxepines)
  • Older adults (65+): Start at a lower dose; be monitored before any increase, as side effects may be more pronounced
  • Liver problems: Start at a lower dose
  • Pregnancy: Use in the third trimester may cause withdrawal-like symptoms in the newborn — discuss risks with your doctor
  • Breastfeeding: Not recommended; talk to your doctor about alternatives
  • Children: Safety and effectiveness have not been studied in pediatric patients
  • Severe sleep apnea: Generally not recommended
🚑If you take too much

Taking much more than the prescribed dose can cause serious problems, including confusion, hallucinations, seizures, irregular heartbeat, severe low blood pressure, and loss of consciousness. If you suspect an overdose, call Poison Control (1-800-222-1222) or go to the emergency room immediately — and bring the pill bottle with you.

An ECG (heart tracing) should be done right away in any suspected overdose, as doxepin at high doses can affect heart rhythm. Do not try to manage it at home.

📡Pharmacodynamics — effects in the body

Doxepin binds very tightly to the H1 histamine receptor in the brain — this is the receptor that normally promotes wakefulness. By blocking it, doxepin dampens that alerting signal and supports sleep. In heart-safety studies, doxepin at doses used for sleep did not affect the QT interval (a measure of heart electrical activity), suggesting a low risk of heart rhythm problems at therapeutic doses.

🔬Pharmacokinetics — how your body processes it

After swallowing a tablet on an empty stomach, doxepin reaches peak blood levels in about 3.5 hours. Eating a high-fat meal within 3 hours of your dose delays that peak by roughly another 3 hours and raises the amount absorbed — which is why you should take it on an empty stomach. Doxepin is broken down mainly in the liver by enzymes called CYP2C19 and CYP2D6, producing an active breakdown product (nordoxepin) that stays in the body even longer. The drug itself has a half-life of about 15 hours, meaning it takes roughly that long for blood levels to drop by half — which is why next-morning drowsiness is a real concern. It is excreted primarily through the urine.

📦How to store it

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

📄 Written from Doxepin (Depression, Anxiety)’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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

I thought doxepin was an antidepressant — why am I getting it for sleep?
Great question. Doxepin has been used at much higher doses for depression, but this lower-dose version is specifically approved to help people who wake up during the night and can't get back to sleep. The two uses are quite different in dose, so your sleep prescription isn't the same thing as an antidepressant — it's a very different, much smaller amount targeted at helping you stay asleep.
Can I eat before taking it at bedtime?
Actually, you should try to avoid eating for at least 3 hours before taking it. Food — especially something high in fat — slows down how quickly the medicine works and can increase the chance you'll feel groggy the next morning. Take it on a relatively empty stomach, within 30 minutes of when you plan to be in bed.
Is it okay to have a glass of wine in the evening while I'm taking this?
No — this is one of the more important ones. Alcohol adds to the sedating effect of doxepin and, more seriously, it raises the risk of doing things in your sleep that you won't remember — like driving, eating, or making phone calls. That's called a complex sleep behavior, and it can be dangerous. It's best to avoid alcohol entirely while you're using doxepin.
What if I'm still not sleeping well after a week or so?
If your sleep hasn't improved after about 7 to 10 days, that's a signal to go back to your doctor. Sometimes persistent insomnia points to an underlying medical or mental health issue that needs its own treatment. Doxepin is meant to help with sleep maintenance, but it's not a substitute for addressing the root cause if one exists.
I'm pregnant — is it safe for me to keep taking this?
You should talk to your doctor right away. Using doxepin in the third trimester, in particular, has been linked to withdrawal-like symptoms in newborns — things like breathing difficulties, feeding problems, and irritability. Your doctor needs to weigh the risks and benefits for you specifically. Breastfeeding is also not recommended while on this medication.
I take a stomach acid medication called cimetidine. Does that matter?
Yes — this is really important to mention to your doctor. Cimetidine can roughly double the amount of doxepin in your bloodstream, which raises the risk of side effects like excessive sedation. Your prescriber may recommend a lower dose of doxepin to keep things safe. Always make sure your entire care team knows about every medication you're taking, including over-the-counter ones.
Is Doxepin (Depression, Anxiety) available over the counter?
Doxepin (Depression, Anxiety) is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

💬 Answers drafted from Doxepin (Depression, Anxiety)’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📈 How widely Doxepin (Depression, Anxiety) is used

A general measure of how commonly Doxepin (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) prescribed? Of the 1,596 medications we measure, Doxepin (Depression, Anxiety) ranks #233 by Medicaid prescriptions — more than 85% of them.

Where Doxepin (Depression, Anxiety) ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Doxepin (Depression, Anxiety) 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 (Depression, Anxiety) product — about 30% of these Medicaid prescriptions.

doxepin 10 MG Oral Capsule Most dispensed

189,409 Medicaid prescriptions (Q1–Q4 2025) 30% of Doxepin (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety) 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 (Depression, Anxiety), 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 (Depression, Anxiety) NDCs with Medicaid activity.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Doxepin (Depression, Anxiety) RxCUI 3638 4 dose forms · 10 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 371962 No current FDA listing
    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 No current FDA listing
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 1000054
  3. Dose form (SCDF) Oral Tablet RxCUI 375040 No current FDA listing
    Clinical drug / strength (SCD) 3 MG RxCUI 966787 6 MG RxCUI 966793
  4. Dose form (SCDF) Topical Cream RxCUI 377691 No current FDA listing
    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.

🏷️ Sold under these brand names

Sinequan Capsules Sinequan Concentrated Solution Prudoxin Zonalon Silenor

RxNorm drug class

Doxepin (Depression, Anxiety) 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.

🔬 Where this comes from

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 (Depression, Anxiety).
📈
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 (Depression, Anxiety) after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Linked representative label
Viona Pharmaceuticals Inc
Linked label effective
Jan 8, 2025
Composite sections available
26
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 we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Viona Pharmaceuticals Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.