Classes
DEA Class; Rx
Common Brand Names; Silenor, Prudoxin, Xepin, Zonalon
- Antidepressants, TCAs
- Topical Skin Products
Description
Dibenzoxepin type tricyclic antidepressant; has substantial anticholinergic and sedative effects.
Used in adults for the treatment of depression/anxiety; low-dose oral product used in adults with insomnia characterized by difficulty with sleep maintenance
Topical cream used only in adults; used short term to relieve pruritus from atopic dermatitis (eczema) or lichen simplex chronicus
Boxed warning for oral use in pediatric patients and young adults due to risk for suicidality
Indications
Contraindications
Hypersensitivity
Untreated narrow-angle glaucoma
Severe urinary retention
Within 14 days of MAO inhibitors
Adverse Effects
Sedation, fatigue, weakness, lethargy
Dry mouth
Constipation
Blurred vision
Headache
Agitation
Insomnia
Anxiety
Nausea, vomiting
Sweating
Confusion, extrapyramidal symptoms (EPS), dizziness, paresthesia
Orthostatic hypotension, ECG changes, tachycardia
Increased LFTs
Tinnitus
Sexual dysfunction
Rash
Seizure
Agranulocytosis
Thrombocytopenia
Eosinophilia
Leukopenia
SIADH
Warnings
Use caution in BPH, urinary retention, decreased GI motility, hyperthyroidism, brain tumor, diabetes, hepatic impairment, cardiovascular disease, mania/hypomania, respiratory disease, and seizure disorders
Clinical worsening and suicidal ideation may occur despite medication in adolescents and young adults (aged 18-24 years)
Risk of anticholinergic side effects
Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy
CNS depressant; can impair alertness and motor coordination; avoid use with other CNS depressants (eg, alcohol)
Overdose may cause EKG QRS widening and risk of dysrhythmias
Protect capsules and oral concentrate from direct sunlight
Prescriptions should be written for smallest quantity consistent with good patient care; patient’s family or caregiver should alert healthcare professional about emergence of suicidality and related behaviors including agitation, panic attacks, irritability, impulsivity, mania, and insomnia or if worsening depression or psychosis occurs
Anticholinergic effects including blurred vision, urinary retention, xerostomia, and constipation may occur
Neuropsychiatric symptoms may occur unpredictably including anxiety and psychosis
Bone fracture reported with use of antidepressant therapy; consider possibility of fracture if patient presents with unexplained bone pain, joint tenderness, bruising or swelling
May cause orthostatic hypotension; use caution in patients at risk of this effect or that may not tolerate hypotensive episodes (eg, hypovolemia, cardiovascular or cerebrovascular disease and others)
Sleep related activities including sleep driving, eating food, cooking, making phone calls reported; discontinue therapy if patient reports sleep-related episodes
Possibility of EPS and neuroleptic malignant syndrome (NMS)
Pregnancy and Lactation
Available data from published epidemiologic studies and postmarketing reports have not established increased risk of major birth defects or miscarriage; there are risks of poor neonatal adaptation with exposure to drug during pregnancy
Data from published report presence of drug and metabolite in human milk; there are reports of excess sedation, respiratory depression, poor sucking and swallowing, and hypotonia in breastfed infants exposed to drug
Maximum Dosage
For the capsules and solution, 300 mg/day PO; for the tablets (Silenor), 6 mg/day PO.
For the capsules and solution, 300 mg/day PO; for the tablets (Silenor), 6 mg/day PO.
Safety and efficacy have not been established; a maximum of 100 mg/day PO or 3 mg/kg/day PO has been suggested for depression; safety and efficacy not established for treatment of insomnia.
7 years and older: Safety and efficacy have not been established; a maximum of 3 mg/kg/day PO has been suggested for depression.
6 years and younger: Safety and efficacy have not been established.
How supplied
Doxepin hydrochloride
capsule (generic)
- 10mg
- 25mg
- 50mg
- 75mg
- 100mg
- 150mg
tablet (Silenor)
- 3mg
- 6mg
oral concentrate (generic)
- 10mg/mL
cream
- 5%