Prescription medication · Tricyclic Antidepressant (TCA)
doxepin
Also sold as Sinequan, Silenor. Doxepin is used to treat insomnia, which means you have trouble staying asleep.
Data updated 2026-05-15
- 9,780
- FDA reportsLightly reported
- 3
- InteractionsFew interactions
- $0.08
- Generic price (NADAC)
What the data shows
doxepin (Sinequan) is a prescription Tricyclic Antidepressant (TCA), reported less often than most tracked drugs (9,780 FDA reports), with 3 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
doxepin (Sinequan) is a prescription Tricyclic Antidepressant (TCA). Doxepin is used to treat insomnia, which means you have trouble staying asleep.
Doxepin is a medicine that can help you stay asleep. It belongs to a class of drugs called tricyclic antidepressants.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from doxepin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of doxepin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of doxepin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of doxepin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store doxepin at room temperature, away from light.
Side Effects (from patient reports)
Based on 9,780 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for doxepin, by number of reports
- Harm from certain substances
Harm from certain substances
801 reports
- Suicide
Suicide
613 reports
- Tiredness
Tiredness
599 reports
- Feeling sick to your stomach
Feeling sick to your stomach
557 reports
- Pain
Pain
526 reports
- Headache
Headache
482 reports
- Itching
Itching
468 reports
- Diarrhea
Diarrhea
431 reports
- Difficulty breathing
Difficulty breathing
418 reports
- Trouble sleeping
Trouble sleeping
417 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for doxepin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where doxepin sits
doxepin has more FDA adverse-event reports than 38% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is doxepin; the line is the median (50th percentile).
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
Reports Mentioning Death
1,746
17.9% of reports — not proof of cause
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 |
| 3 | COMPLETED SUICIDE | 613 |
| 4 | FATIGUE | 599 |
| 5 | NAUSEA | 557 |
| 6 | PAIN | 527 |
| 7 | HEADACHE | 482 |
| 8 | PRURITUS | 468 |
| 10 | DIARRHOEA | 431 |
| 11 | DYSPNOEA | 418 |
| 12 | INSOMNIA | 417 |
| 13 | CHRONIC KIDNEY DISEASE | 408 |
| 14 | DIZZINESS | 405 |
| 15 | ANXIETY | 401 |
| 16 | DEPRESSION | 392 |
| 17 | FALL | 382 |
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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
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alprazolam
Xanax
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amitriptyline
Elavil
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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
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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
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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 9,780 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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