Doxepin Hydrochloride 10 mg/mL Solution, 120 mL
Other active recalls for Doxepin Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Tricyclic Antidepressant class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Good question — doxepin does have a history as an antidepressant, but what you're being prescribed is a much lower-dose version specifically approved for sleep. It's used for peopl...
- What exactly is doxepin being used for here? I thought it was an antidepressant.
- Yes, timing really does matter. You should take doxepin at least 3 hours after your last meal — especially if that meal was high in fat. Eating close to your dose makes the medicat...
- Does it matter when I take it or if I eat first?
Patient education
Supplement & herbal interactions
Doxepin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.779 | $93.47 / 120 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.5267 | $63.20 / 120 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.9281 | $111.37 / 120 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxepin Hydrochloride 10 mg/mLthis 54838-0512-40 | Lannett | 120 ml | $0.779 | — | Availability likely | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54838-0512-40 You're viewing this | 120 mL in 1 BOTTLE, PLASTIC (54838-512-40) | 1998-12-29 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . D oxepin hydrochloride is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behaviors in pediatric and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Doxepin hydrochloride is not approved for use in pediatric patients ( 8.4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Doxepin hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride is a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with doxepin hydrochloride, 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. ( 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, gradually reduce the dosage until discontinued. ( 2.7 ) See Full Prescribing Information for recommended preparation instructions for the oral solution. ( 2.8 )
2.1Screen for Bipolar Disorder Prior to Starting Doxepin Hydrochloride Prior to initiating treatment with doxepin hydrochloride, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5 )] .
2.2Recommended Dosage The recommended starting oral dosage for doxepin hydrochloride is 25 mg three times daily or 75 mg once daily. The recommended target total oral dosage range for doxepin hydrochloride is 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 is 100 mg three times daily.
2.3Switching 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 [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7 )] . Wait at least 14 days after discontinuation of doxepin hydrochloride before initiating therapy with an MAOI [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7 )] .
2.4Dosage Modifications Intended to Reduce the Risk of Anticholinergic Effects If anticholinergic effects (e.g., dry mouth, blurred vision, constipation) develop, reduce the doxepin hydrochloride dosage [see Adverse Reactions ( 6.1 )] .
2.5Dosage Modifications for Strong CYP2D6 Inhibitors Reduce the doxepin hydrochloride dosage based on doxepin plasma concentrations when used concomitantly with strong CYP2D6 inhibitors [see Drug Interactions ( 7 )] .
2.6Dosage Modifications in Known CYP2D6 and CYP2C19 Poor Metabolizers Reduce the doxepin hydrochloride dosage based on doxepin plasma concentrations in patients who are known CYP2D6 and CYP2C19 poor metabolizers [see Use in Specific Populations ( 8.7 )] .
2.7Discontinuation of Doxepin Hydrochloride Treatment When discontinuing doxepin hydrochloride, gradually reduce the dosage until discontinued [see Adverse Reactions ( 6 )] .
2.8Preparation of Doxepin Hydrochloride Oral Solution Recommended preparation instructions for the Doxepin Hydrochloride Oral Solution are as follows: Use the supplied calibrated dropper to measure the amount of Doxepin Hydrochloride Oral Solution needed. The calibrated dropper has markings at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Just prior to administration, mix doxepin hydrochloride with 120 mL of water, whole or skimmed milk, or orange, grapefruit, tomato, prune, or pineapple juice.
Do not mix with other liquids. Administer the dose immediately after mixing.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oral solution: Each mL of oral solution contains 10 mg of doxepin as a clear, colorless solution for dilution prior to administration [see Dosage and Administration ( 2.8 )] . Supplied as a 120 mL bottle with accompanying calibrated dropper with 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg markings. Oral solution: 10 mg per mL ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Doxepin hydrochloride is contraindicated in patients: With hypersensitivity to doxepin (hypersensitivity reactions have included tongue edema and urticaria). The possibility of cross sensitivity with other dibenzoxepines should be kept in mind. With glaucoma [see Warnings and Precautions ( 5.3 )] .
With current or past urinary retention [see Adverse Reactions ( 6.1 )] . Taking MAOIs, or within 14 days of stopping MAOIs (including the MAOIs linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 )] . Hypersensitivity to doxepin ( 4 ) Glaucoma ( 4 ) Current or past urinary retention ( 4 ) Taking MAOIs, or within 14 days of stopping MAOIs ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Suicidal Thoughts and Behaviors : Monitor for clinical worsening and suicide thoughts and behaviors. Consider changing the therapeutic regimen, including possibly discontinuing doxepin hydrochloride, in patients who are experiencing emergent suicidal thoughts or behaviors. ( 5.1 ) Serotonin Syndrome : Risk increases with concomitant use of other serotonergic drugs.
Monitor all patients taking doxepin hydrochloride for the emergence of serotonin syndrome. Discontinue doxepin hydrochloride and any concomitant serotonergic agents immediately and initiate supportive treatment if serotonin syndrome occurs. ( 5.2 , 7 ) Angle-Closure Glaucoma : Avoid use of doxepin hydrochloride in patients with untreated anatomically narrow angles.
( 5.3 ) Sedation and Driving Risks : Because doxepin hydrochloride can cause sedation, warn patients against driving a car or operating dangerous machinery while taking doxepin hydrochloride. ( 5.4 ) Activation of Mania or Hypomania : Prior to initiating antidepressant therapy, screen for bipolar disorder. Doxepin hydrochloride is not approved for use in treating bipolar depression.
( 5.5 )
5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs including tricyclic antidepressants and other antidepressant classes that included approximately 77,000 adult patients and 4,500 pediatric patients (doxepin hydrochloride is not approved for use in pediatric patients), the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.
The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo < 18 years old 14 additional patients 18-24 years old 5 additional patients Decreases Compared to Placebo 25-64 years old 1 fewer patient ≥ 65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adults extends to longer-term use, i.e., beyond four months.
However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. Monitor all doxepin hydrochloride-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of doxepin hydrochloride therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.
Consider changing the therapeutic regimen, including possibly discontinuing doxepin hydrochloride, in patients who are experiencing emergent suicidal thoughts or behaviors.
5.2Serotonin Syndrome Tricyclic antidepressants, including doxepin hydrochloride, can precipitate serotonin syndrome, a potentially life-threatening condition. This risk is increased with concomitant use of other serotonergic drugs (e.g., other tricyclic antidepressants, SSRIs, serotonin norepinephrine reuptake inhibitors, triptans, tetracyclic antidepressants, opioids), lithium, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (e.g., MAOIs intended to treat psychiatric disorders and others, such as linezolid or intravenous methylene blue) [see Drug Interactions ( 7 )] .
Serotonin syndrome symptoms may include mental status changes…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.3 )] Sedation and Driving Risks [see Warnings and Precautions ( 5.4 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.5 )] Risk of Seizures [see Warnings and Precautions ( 5.6 )] Psychosis [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions (≥ 2% of doxepin hydrochloride-treated patients) in 1,635 doxepin hydrochloride-treated patients with MDD in clinical trials included somnolence (17%), dry mouth (15%), dizziness (6%), constipation (5%), fatigue (5%), blurred vision (3%), tachycardia (3%), hypotension (3%), insomnia (2%), tremor (2%), nausea (2%), hyperhidrosis (2%), and increased weight (2%).
Other Adverse Reactions Observed in Clinical Trials Other adverse reactions that occurred at an incidence of < 2% in patients treated with doxepin hydrochloride in clinical trials were: Ear and Labyrinth Disorders : Tinnitus. Gastrointestinal Disorders : Diarrhea, dyspepsia, vomiting. General Disorders and Administration Site Conditions : Asthenia, edema, chills.
Metabolism and Nutrition Disorders : Decreased appetite. Nervous System Disorders : Ataxia, paresthesia, headache, extrapyramidal disorder. Psychiatric Disorders : Agitation, confusional state, libido decreased.
Pulmonary Disorders : Asthma exacerbation. Renal and Urinary Disorders : Urinary retention. Reproductive System and Breast Disorders : Breast enlargement.
Skin & Subcutaneous Tissue Disorders : Rash, pruritus. Vascular Disorders : Flushing.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of doxepin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders : Agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, purpura.
Cardiac Disorders : Conduction disorder, arrhythmia. Endocrine Disorders : Inappropriate antidiuretic hormone secretion. Eye Disorders : Angle-closure glaucoma, mydriasis.
Gastrointestinal Disorders : Aphthous stomatitis, abdominal pain upper. General Disorders and Administration Site Conditions : Facial edema, hyperpyrexia. Hepatobiliary Disorders : Jaundice.
Investigations : Blood glucose increased. Nervous System Disorders : Hypoesthesia, dysgeusia, convulsion, tardive dyskinesia, serotonin syndrome. Psychiatric Disorders : Hallucination, disorientation.
Reproductive System and Breast Disorders : Testicular swelling, gynecomastia, galactorrhea. Skin and Subcutaneous Tissue Disorders : Photosensitivity reaction, tongue edema, alopecia, urticaria. Vascular Disorders : Hypertension.
Withdrawal syndrome occurred after stopping doxepin hydrochloride [see Drug Abuse and Dependence ( 9.3 )] . The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 2 describe the clinically significant drug interactions of doxepin hydrochloride with other drugs or classes. Table 2: Clinically Significant Drug Interactions with Doxepin Hydrochloride Monoamine Oxidase Inhibitors Prevention or Management Doxepin hydrochloride is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue. The use of doxepin hydrochloride within 14 days of discontinuation of an MAOI or the use of MAOI within 14 days of discontinuation of doxepin hydrochloride is contraindicated.
Starting doxepin hydrochloride in a patient who is being treated with an MAOI is contraindicated. Clinical Effect(s) Concomitant use of doxepin hydrochloride 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 and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )] . Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride 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 dosage or the strong CYP2D6 inhibitor as appropriate [see Dosage and Administration ( 2.5 )] .
Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride with strong CYP2D6 inhibitors may increase the exposures of doxepin [see Clinical Pharmacology ( 12.3 )] which may increase the risk of doxepin hydrochloride related adverse reactions [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )] . Examples See www.fda.gov/CYPandTransporterInteractingDrugs for examples of strong CYP2D6 Inhibitors. Carbamazepine Prevention or Management Monitor doxepin plasma concentrations and consider increasing the doxepin hydrochloride dosage in patients taking carbamazepine.
Mechanism and Clinical Effect(s) Concomitant use of carbamazepine with doxepin hydrochloride decreases the exposure of doxepin [see Clinical Pharmacology ( 12.3 )] which could lead to reduced treatment effect. Cimetidine Prevention or Management Monitor doxepin plasma concentrations and consider reducing the doxepin hydrochloride dosage in patients taking cimetidine. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride with cimetidine may increase the exposures of doxepin [see Clinical Pharmacology ( 12.3 )] which may increase the risk of doxepin hydrochloride-related anticholinergic effects (e.g., dry mouth, blurred vision, constipation) [see Adverse Reactions ( 6.1 )] .
Alcohol Prevention or Management Avoid concomitant use with alcohol. Mechanism and Clinical Effect(s) Doxepin hydrochloride may potentiate the sedative effects of alcohol [see Warnings and Precautions ( 5.4 )] . CNS Depressants Prevention or Management Dosage reduction of doxepin hydrochloride and/or the CNS depressant may be needed based on clinical response and tolerability.
Mechanism and Clinical Effect(s) When concomitantly administered with doxepin hydrochloride, the sedative effects of CNS depressant may be potentiated [see Warnings and Precautions ( 5.4 )] . Tolazamide Prevention or Management Monitor glucose levels and reduce the doxepin hydrochloride dosage as appropriate. Clinical Effect(s) Doxepin hydrochloride may cause severe hypoglycemia when concomitantly used with tolazamide.
Serotonergic Drugs : 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 and/or concomitant serotonergic drugs. ( 5.2 , 7 ) Strong CYP2D6…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy : Neonates exposed to TCAs, including doxepin hydrochloride, late in the third trimester have developed poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability). Monitor neonates who were exposed to doxepin hydrochloride in the third trimester of pregnancy for poor neonatal adaptation syndrome. ( 8.1 ) Lactation : Breastfeeding not recommended.
( 8.2 ) Geriatric Use : May cause confusion and oversedation. ( 8.5 ) CYP2C19 and CYP2D6 Poor Metabolizers : Increased risk of doxepin hydrochloride-associated adverse reactions. ( 8.7 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including doxepin hydrochloride, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants . Risk Summary Available data from published epidemiological studies and postmarketing reports have not established an increased risk for major birth defects or miscarriage with doxepin hydrochloride use (see Data ) .
There are risks (see Clinical Considerations ) : To the mother associated with untreated depression in pregnancy. Poor neonate adaptation from exposure to tricyclic antidepressants (TCAs), including doxepin hydrochloride, during the third trimester of pregnancy. Animal reproduction toxicity of doxepin has not been fully characterized.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of MDD than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of MDD who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated MDD when considering discontinuation of doxepin hydrochloride drugs during pregnancy and the postpartum period.
Fetal/Neonatal Adverse Reactions Neonates previously exposed to TCAs, including doxepin hydrochloride, late in the third trimester during pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.
These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome. Monitor neonates who were exposed to doxepin hydrochloride in the third trimester of pregnancy for poor neonatal adaptation syndrome. Data Human Data: Published epidemiological studies of pregnant women exposed to TCAs, including doxepin hydrochloride, have not established an association with major birth defects, miscarriage, or adverse maternal outcomes.
Methodological limitations of these observational studies include small sample size and lack of adequate controls.
8.2Lactation Risk Summary Data from published literature report the presence of doxepin and nordoxepin in human milk. There are reports of excessive sedation, respiratory depression, poor suckling and swallowing and hypotonia in breastfed infants exposed to doxepin at doses used to treat MDD…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including doxepin hydrochloride, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants . Risk Summary Available data from published epidemiological studies and postmarketing reports have not established an increased risk for major birth defects or miscarriage with doxepin hydrochloride use (see Data ) .
There are risks (see Clinical Considerations ) : To the mother associated with untreated depression in pregnancy. Poor neonate adaptation from exposure to tricyclic antidepressants (TCAs), including doxepin hydrochloride, during the third trimester of pregnancy. Animal reproduction toxicity of doxepin has not been fully characterized.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of MDD than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of MDD who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated MDD when considering discontinuation of doxepin hydrochloride drugs during pregnancy and the postpartum period.
Fetal/Neonatal Adverse Reactions Neonates previously exposed to TCAs, including doxepin hydrochloride, late in the third trimester during pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.
These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome. Monitor neonates who were exposed to doxepin hydrochloride in the third trimester of pregnancy for poor neonatal adaptation syndrome. Data Human Data: Published epidemiological studies of pregnant women exposed to TCAs, including doxepin hydrochloride, have not established an association with major birth defects, miscarriage, or adverse maternal outcomes.
Methodological limitations of these observational studies include small sample size and lack of adequate controls.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of doxepin hydrochloride in pediatric patients have not been established. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Warnings and Precautions ( 5.1 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of doxepin hydrochloride did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Sedating drugs, including doxepin hydrochloride, may cause confusion and oversedation in geriatric patients. The recommended starting doxepin hydrochloride dosage in geriatric patients is generally lower than those of younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE Signs, Symptoms, and Complications of Doxepin Hydrochloride Overdose Serious manifestations of tricyclic antidepressant (TCA) overdose include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Deaths may occur from overdosage with TCAs, including doxepin hydrochloride. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of TCA toxicity.
A maximal limb-lead QRS duration of ≥ 0.1 seconds may be the best indication of the TCA overdose severity. Signs and symptoms of TCA toxicity develop rapidly after TCA overdose. Other signs of TCA overdose may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, or hyperpyrexia.
There are reports of patients succumbing to fatal dysrhythmia late after TCA overdose. Management of Overdose The following are recommendations for the management of a doxepin hydrochloride overdose. Contact the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
With a doxepin hydrochloride overdose, obtain an ECG and immediately initiate cardiac monitoring in the hospital. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS depression, respiratory depression, hypotension, cardiac dysrhythmias, conduction blocks, and seizures is recommended. If signs of toxicity occur during this period, extended monitoring is recommended.
Monitoring of plasma doxepin levels should not guide doxepin hydrochloride overdose management. Cardiovascular Toxicity Management: Intravenous sodium bicarbonate should be administered to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate to intravenous sodium bicarbonate therapy, hyperventilation may also be used.
With concomitant use of hyperventilation and sodium bicarbonate therapy frequently monitor pH and pCO2. A pH > 7.6 or a pCO2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to intravenous sodium bicarbonate therapy/hyperventilation may respond to lidocaine therapy.
Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide) in the setting of TCA overdose. Hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in TCA overdose due to high tissue and protein binding of doxepin. CNS Toxicity Management: In patients with TCA overdose who have CNS depression, early intubation is recommended because of the potential for abrupt deterioration.
Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, propofol). Avoid use of physostigmine to treat TCA overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of the doxepin hydrochloride in the treatment of MDD in adult patients is not well understood.
12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of doxepin have not been fully characterized.
12.3Pharmacokinetics Absorption In healthy volunteers, a single oral doxepin hydrochloride dose of 75 mg resulted in peak plasma doxepin concentrations that ranged from 8.8 ng/mL to 45.8 ng/mL (mean 26.1 ng/mL). Peak levels were reached between 2 and 4 hours (mean 2.9 hours) after doxepin hydrochloride administration. Peak levels for the primary active metabolite N-desmethyldoxepin (nordoxepin) ranged from 4.8 ng/mL to 14.5 ng/mL (mean 9.7 ng/mL) and were achieved between 2 and 10 hours after doxepin hydrochloride administration.
Distribution The mean apparent volume of distribution for doxepin was approximately 20 L/kg. The protein binding for doxepin was approximately 76%. Elimination In healthy volunteers, the plasma elimination half-life of doxepin ranged from 8 to 24 hours (mean 17 hours).
The half-life of nordoxepin ranged from 33 to 80 hours (mean 51 hours). The mean plasma clearance for doxepin was approximately
0.84L/hour/kg. Metabolism After oral doxepin hydrochloride administration, approximately 55% to 87% of doxepin undergoes first-pass metabolism in the liver, forming the primary active metabolite nordoxepin. Metabolic pathways of doxepin include demethylation, N-oxidation, hydroxylation and glucuronide formation.
Excretion Doxepin is excreted primarily in the urine, mainly as its metabolites, either free or in conjugate form. Specific Populations Patients with Hepatic Impairment: Specific clinical studies have not been performed to evaluate the pharmacokinetics of doxepin in patients with hepatic impairment. Patients with hepatic impairment may have a greater systemic doxepin exposure than those with normal liver function [see Use in Specific Populations ( 8.6 )] .
Patients with Renal Impairment: The extent of renal excretion of doxepin is unknown. Specific clinical studies have not been performed to evaluate the pharmacokinetics of doxepin in patients with renal impairment compared to those with normal renal function. Drug Interaction Studies Carbamazepine: After concomitant use of doxepin hydrochloride and carbamazepine, the combined exposure of doxepin and nordoxepin (12 hours after the last dose) was decreased by 55% compared to that after the use of doxepin hydrochloride alone [see Drug Interactions ( 7 )] .
Strong CYP2D6 Inhibitors: CYP2D6 contributes to the metabolism of doxepin and concomitant use of doxepin hydrochloride with strong CYP2D6 inhibitors may increase doxepin exposure [see Drug Interactions ( 7 )] . Cimetidine: Cimetidine is a non-specific inhibitor of CYP1A2, 2C19, 2D6, and 3A4. When cimetidine 300 mg twice daily was administered concomitantly with a single 6 mg dose of another oral doxepin product, there was approximately a 2-fold increase in doxepin C max and AUC compared to doxepin without cimetidine [see Drug Interactions ( 7 )] .
CYP2D6 Substrates: Concomitant use of doxepin hydrochloride and other CYP2D6 substrates may have impact on the plasma doxepin concentrations. The clinical significance of this possible impact is unknown.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of the doxepin hydrochloride in the treatment of MDD in adult patients is not well understood.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxepin Hydrochloride Oral Solution USP (Concentrate). Each mL of oral solution contains 10 mg of doxepin as a clear, colorless solution and is supplied in 120 mL bottles (NDC 54838-512-40) with an accompanying dropper calibrated at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Store Doxepin Hydrochloride Oral Solution USP at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C 19 H 21 NO·HCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform.
Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b , e ]oxepin-11(6 H )ylidene- N , N -dimethyl-, hydrochloride. The structural formula of doxepin is shown below. doxepin hydrochloride Doxepin Hydrochloride Oral Solution USP is available as a concentrate for oral administration containing doxepin hydrochloride equivalent to 10 mg of doxepin per mL.
It also contains the following inactive ingredients: glycerin; methylparaben; peppermint flavor; propylparaben; water. May contain hydrochloric acid and/or sodium hydroxide. doxepin hydrochloride
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during doxepin hydrochloride treatment and when the dosage is increased or decreased, and instruct them to report suicidal thinking and behavior to their healthcare provider [see Warnings and Precautions ( 5.1 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome particularly with the concomitant use of doxepin hydrochloride and other serotonergic drugs (e.g., other TCAs, SSRIs, SNRIs, triptans, opioids), lithium, tryptophan, buspirone, and St.
John’s Wort and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid) [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )] . Instruct patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Angle-Closure Glaucoma Advise patients that taking doxepin hydrochloride can cause pupillary dilation, which in susceptible individuals, can trigger angle closure glaucoma.
Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.3 )] . Effects on Driving and Operating Heavy Machinery Inform patients that doxepin hydrochloride can cause sedation and caution them against driving a car or operating dangerous machinery while taking doxepin hydrochloride [see Warnings and Precautions ( 5.4 )] . Activation of Mania or Hypomania Advise patients to observe for signs of mania/hypomania activation and instruct them to report such symptoms to the healthcare provider.
Drug Interactions Inform patients that the use of doxepin hydrochloride and certain other drugs increases the risk of doxepin hydrochloride-associated adverse reactions or alternatively lower doxepin hydrochloride effectiveness. Instruct patients to inform their healthcare provider about all the drugs that they are taking before taking doxepin hydrochloride. Alcohol Use Advise patients to avoid the use of alcohol while taking doxepin hydrochloride [see Drug Interactions ( 7 )] .
Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to doxepin hydrochloride during pregnancy. Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during doxepin hydrochloride treatment. Advise pregnant women that doxepin hydrochloride use late in pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, or tube feeding [see Use in Specific Populations ( 8.1 )] .
Lactation Advise patients that breastfeeding is not recommended during doxepin hydrochloride treatment [see Use in Specific Populations ( 8.2 )] . Important Administration Instructions for the Oral Solution For patients prescribed Doxepin Hydrochloride Oral Solution, tell them to: Use the supplied calibrated dropper to measure the amount of oral solution needed. Just prior to administration, mix Doxepin Hydrochloride Oral Solution with 120 mL of water, whole or skimmed milk, or orange, grapefruit, tomato, prune or pineapple juice only.
Do not mix with anything other than the liquids listed. Administer the dose immediately after mixing. Distributed by: Lannett Company, Inc.
Philadelphia, PA 19136 This product’s labeling may have been updated. For the most recent Prescribing Information, please visit www.lannett.com. CIB72247A Rev.
07/2025
💬 Medication Guide ▾
MEDICATION GUIDE Doxepin Hydrochloride (dox’ e pin hye”droe klor’ ide) Oral Solution USP (Concentrate) What is the most important information I should know about doxepin hydrochloride? Doxepin hydrochloride can cause serious side effects, including: Increased risk of suicidal thoughts and actions. Doxepin hydrochloride 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 is 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 healthcare 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 healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare 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? ” for more information about side effects.
What is doxepin hydrochloride? Doxepin hydrochloride is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). It is not known if doxepin hydrochloride is safe and effective for use in children.
Do not take doxepin hydrochloride if you: are allergic to doxepin, or any of the ingredients in doxepin hydrochloride. See the end of this Medication Guide for a complete list of ingredients in doxepin hydrochloride have glaucoma have or have had trouble urinating are taking, or have stopped taking within the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue Ask your healthcare provider or pharmacist if you are not sure if you are taking an MAOI, including the antibiotic linezolid or intravenous methylene blue Do not start taking an MAOI for at least 14 days after you stop treatment with doxepin hydrochloride Before taking doxepin hydrochloride, tell your healthcare provider about all your medical conditions, including if you: have, or have a family history of bipolar disorder, mania, or hypomania have or had depression, suicidal thoughts or behavior have kidney or liver problems have or had seizures or convulsions are pregnant or plan to become pregnant.
Taking doxepin hydrochloride during your third trimester of pregnancy may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with doxepin hydrochloride Babies born to mothers who take certain medicines, including doxepin hydrochloride, during the third trimester of pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, low muscle tone, feeding problems, and withdrawal symptoms. Talk to your healthcare provider about the risks to your unborn or newborn baby if you take doxepin hydrochloride during pregnancy There is a pregnancy registry for women who are exposed to doxepin hydrochloride during pregnancy.
The purpose of this registry is to collect information about the health of wome…