doxepin
Brand names: Sinequan, Silenor
Doxepin is a medicine that can help you stay asleep. It belongs to a class of drugs called tricyclic antidepressants.
Drug Pricing (NADAC)
Generic Price
$0.08/unit
Generic Available
Yes (28 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Doxepin is used to treat insomnia, which means you have trouble staying asleep.
Common side effects
Feeling sleepy or drowsy, Feeling sick to your stomach, Upper respiratory tract infection (like a cold)
Key warnings
After taking doxepin, some people have done things like driving a car while not fully awake.
How It Works
Doxepin works by affecting certain natural chemicals in the brain that help regulate sleep. It helps to keep you asleep throughout the night. It is a low dose formulation of a tricyclic antidepressant.
How to Take It
Take doxepin within 30 minutes before you go to bed. Adults usually take 6 mg once a day. If you are elderly, your doctor may start you on 3 mg once a day. Do not take it within 3 hours of eating a meal.
Pregnancy & Breastfeeding
Taking doxepin late in pregnancy may cause problems for the newborn baby, like trouble breathing or feeding. Breastfeeding is not recommended while taking this medicine.
Missed Dose
If you miss a dose, skip that dose and take your next dose at your regular time. Do not take two doses at once.
Storage
Store doxepin at room temperature, away from light.
Side Effects (from patient reports)
Based on 5,633 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 9,780 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1998–2025.
Total Reports
9,780
Death-Related Reports
1,746
Hospitalization Reports
2,865
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | TOXICITY TO VARIOUS AGENTS | 801 |
| 2 | DRUG INEFFECTIVE | 707 |
| 3 | COMPLETED SUICIDE | 613 |
| 4 | FATIGUE | 599 |
| 5 | NAUSEA | 557 |
| 6 | PAIN | 527 |
| 7 | HEADACHE | 482 |
| 8 | PRURITUS | 468 |
| 9 | OFF LABEL USE | 449 |
| 10 | DIARRHOEA | 431 |
| 11 | DYSPNOEA | 418 |
| 12 | INSOMNIA | 417 |
| 13 | CHRONIC KIDNEY DISEASE | 408 |
| 14 | DIZZINESS | 405 |
| 15 | ANXIETY | 401 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
After taking doxepin, some people have done things like driving a car while not fully awake. You might not remember doing it. This can be dangerous, so tell your doctor right away if this happens. Doxepin may also worsen depression or cause suicidal thoughts. Tell your doctor if you notice any new or worsening symptoms of depression.
Known Drug Interactions
( 4.2 ) Cimetidine: Increases exposure to doxepin. 7.2 Cimetidine Doxepin exposure is doubled with concomitant administration of cimetidine, a nonspecific inhibitor of CYP isozymes. A maximum dose of 3 mg is recommended in adults and elderly when cimetidine is co-administered with doxepin [see Clinical Pharmacology (12.3 )] 7.3 Alcohol When taken with doxepin, the sedative effects of alcohol may be potentiated [ see Warnings and Precautions (5.2 , 5.4 )].
Mechanism: Cimetidine blocks the enzymes that normally break down doxepin, which causes the amount of doxepin in your body to double.
What to do: Your doctor should limit your doxepin dose to a maximum of 3 mg if you are taking both of these medicines.
Examples: amitriptyline, desipramine, doxepin, imipramine, nortriptyline.
Mechanism: Doxepin can increase how strongly your body reacts to dopamine. This can lead to unexpected changes in your heart rate or blood pressure.
What to do: Healthcare providers should keep a close eye on your vital signs. The dose of dopamine may need to be lowered.
( 7.1 ) Doxepin: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin. Doxepin The AUC 0-inf and C max of ramelteon increased by approximately 66% and 69%, respectively, upon coadministration of doxepin with ramelteon. Patients should be closely monitored when ramelteon is coadministered with doxepin [see Clinical Pharmacology (12.5) ] .
Mechanism: Taking doxepin can raise the levels of ramelteon in your body by slowing down its breakdown.
What to do: You should be monitored closely by your healthcare provider to ensure the combination is safe for you.
Common Questions
Can I drink alcohol while taking doxepin?
What should I do if I feel more depressed after starting doxepin?
Can I drive after taking doxepin?
How long does it take for doxepin to start working?
Can I take doxepin with other sleep medicines?
What if I accidentally take too much doxepin?
Can I stop taking doxepin suddenly?
Is doxepin addictive?
Does doxepin interact with any other medications?
What should I do if I experience side effects?
What are the common side effects of doxepin?
Does doxepin interact with other medications?
What drug class is doxepin?
Is doxepin safe during pregnancy?
Related Medications in Tricyclic Antidepressant (TCA)
Other drugs grouped near doxepin — same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
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What the FDA Data Shows for doxepin
The FDA label for doxepin (sold under brand names such as Sinequan, Silenor) classifies it as a prescription-only medication in the Tricyclic Antidepressant (TCA) class. Doxepin is used to treat insomnia, which means you have trouble staying asleep. Official labeling lists 3 commonly reported side effects, including Feeling sleepy or drowsy, Feeling sick to your stomach, Upper respiratory tract infection (like a cold).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,633 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.08.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 24, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages