Doxepin Sinequan

This medication guide provides information about the use of doxepin (Sinequan or other generic names) to treat depression or anxiety. Silenor is another brand of doxepin that is not covered in this medication guide.

Doxepin is a tricyclic antidepressant that affects chemicals in the brain that may be unbalanced.

Doxepin (Sinequan or other generic name) is used to treat symptoms of depression and/or anxiety associated with alcoholism, psychiatric conditions, or manic-depressive conditions.

Doxepin may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Applies to doxepin: oral capsule, oral concentrate, oral tablet

General

Capsules and Oral Concentrate: The most frequently reported side effects were constipation, dry mouth, and drowsiness.

Tablets (3 and 6 mg): The most frequently reported side effects were somnolence/sedation, nausea, and upper respiratory tract infection.[Ref]

Nervous system

Common (1% to 10%): Somnolence/sedation
Frequency not reported: Drowsiness, numbness, paresthesia, ataxia, extrapyramidal symptoms, seizure, tardive dyskinesia, tremor, dizziness, headache, neuroleptic malignant-like syndrome, convulsion, hyperreflexia in neonate, lethargy, syncope, ageusia, cerebrovascular accident, disturbance in attention, migraine, sleep paralysis, syncope vasovagal
Postmarketing reports: Hypoesthesia, dysgeusia[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Frequency not reported: Hypotension, flushing, tachycardia, ECG changed, postural hypotension, atrioventricular block, palpitation, ventricular extrasystole, ECG ST-T segment abnormal, ECG QRS complex abnormal, heart rate decreased, QRS axis abnormal, pallor, blood pressure inadequately controlled, hematoma, hot flush
Postmarketing reports: Arrhythmia, conduction disorder[Ref]

Gastrointestinal

Common (1% to 10%): Gastroenteritis, nausea
Frequency not reported: Dry mouth, constipation, vomiting, indigestion, taste disturbance, diarrhea, anorexia, aphthous stomatitis, abdominal pain, gastroesophageal reflux disease, dyspepsia, gingival recession, hematochezia, lip blister
Postmarketing reports: Tongue edema, upper abdominal pain[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection/nasopharyngitis
Frequency not reported: Asthma exacerbated, respiratory depression in neonate, bronchitis, laryngitis, sinusitis, lower respiratory tract infection, pharyngitis, pneumonia, nasal congestion, pharyngolaryngeal pain, sinus congestion, wheezing, cough, crackles lung, nasopharyngeal disorder, rhinorrhea, dyspnea[Ref]

Psychiatric

Frequency not reported: Confusion, disorientation, hallucination, libido decreased, libido increased, withdrawal symptom, agitation, anxiety, nervousness, aggressive reaction, suicidal ideation, suicidal behavior, insomnia, nightmare, mania exacerbated, paranoid delusions exacerbated, dream abnormal, adjustment disorder, depression, elevated mood[Ref]

Other

Frequency not reported: Edema, tinnitus, weight gain, chills, fatigue, weakness, hyperpyrexia, asthenia, bone fracture, drug tolerance, ear pain, hypoacusis, motion sickness, tympanic membrane perforated, chest pain, gait abnormal, peripheral edema, fungal infection, tooth infection, viral infection, cellulitis staphylococcal, folliculitis, gastroenteritis viral, herpes zoster, infective tenosynovitis, influenza, onychomycosis, back injury, fall, joint sprain, skin laceration, sensation of heaviness, arthrodesis
Postmarketing reports: Malaise[Ref]

Endocrine

Frequency not reported: Gynecomastia, breasts enlarged, galactorrhea, testicular swelling, syndrome of inappropriate antidiuretic hormone[Ref]

Oncologic

Frequency not reported: Lung adenocarcinoma stage I, malignant melanoma, breast cyst[Ref]

Genitourinary

Frequency not reported: Urinary retention, urinary tract infection, dysmenorrhea, dysuria, enuresis, hemoglobinuria, nocturia[Ref]

Hematologic

Frequency not reported: Eosinophilia, bone marrow depression, agranulocytosis, leukopenia, thrombocytopenia, hemolytic anemia, thrombocythemia, anemia, neutrophil count decreased[Ref]

Hepatic

Frequency not reported: Jaundice, hepatitis, hepatic abnormality, hyperbilirubinemia, ALT increased, transaminases increased[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, back pain, myalgia, neck pain, pain in extremity, muscle cramp, joint range of motion decreased[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, photosensitivity, purpura, sweating, alopecia, face edema, urticaria, hyperhidrosis, cold sweat, skin irritation, dermatitis, erythema, rosacea[Ref]

Immunologic

Frequency not reported: Hypersensitivity[Ref]

Metabolic

Frequency not reported: Blood sugar increased, blood sugar decreased, appetite increased, anorexia, appetite decreased, hyperkalemia, hypermagnesemia, hypokalemia[Ref]

Ocular

Frequency not reported: Vision blurred, angle closure glaucoma, mydriasis, intraocular pressure increased, eye redness, blepharospasm, diplopia, eye pain, lacrimation decreased, eye infection[Ref]

Some side effects of doxepin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Capsules and Oral Concentrate: Data not available

Tablets: Initiate treatment with 3 mg orally once a day; monitor closely for adverse daytime effects

• Doxepin is used to treat depression and is thought to work by increasing levels of norepinephrine in the brain.
• Doxepin belongs to a group of medicines known as tricyclic antidepressants.

• Effective for the treatment of depression and/or anxiety.
• May be used to treat depression or anxiety associated with alcohol use, neurosis, or manic-depressive disorders.
• Symptoms that respond well to doxepin include anxiety, depression, associated somatic symptoms such as pain or fatigue, fear, guilt, sleep disturbances, tension, and worry.

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C (tablets) US FDA pregnancy category: Not formally assigned to a pregnancy category (capsules and oral concentrate) Comments: Withdrawal symptoms in newborn infants have been reported following prolonged maternal use of tricyclic antidepressants.

Animal studies with the capsule and oral concentrate formulations have failed to reveal evidence of fetal harm; however, evidence exists regarding interference with central monoamine neurotransmission in rats. Animal studies with the tablet formulation have revealed evidence of developmental toxicity, including increased incidences of fetal structural abnormalities and decreased fetal body weights when this drug was administered at higher doses. Decreased pup survival and transient growth delay have also been reported at the highest dose. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended. -According to some authorities: Use is contraindicated. Excreted into human milk: Yes Comments: -Apnea and drowsiness have been reported in the nursing infant. -If treatment is required in a mother of an older infant, the nursing infant should be monitored carefully for excessive sedation and adequate weight gain.

Substance Name

Doxepin

CAS Registry Number

1668-19-5

Drug Class

Antidepressants

Tricyclic Antidepressants