Skip to content


    DEA Class;  Rx

    Common Brand Names; Silenor, Prudoxin, Xepin, Zonalon

    • Antidepressants, TCAs
    • Topical Skin Products

    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

    Indicated for the treatment of major depression and/or anxiety, including psychotic depressive disorders with associated anxiety.
    For the treatment of insomnia characterized by difficulties with sleep maintenance.
    For the topical treatment of eczematous dermatitis (atopic dermatitis, eczema, or lichen simplex chronicus).


    Untreated narrow-angle glaucoma

    Severe urinary retention

    Within 14 days of MAO inhibitors

    Sedation, fatigue, weakness, lethargy

    Dry mouth


    Blurred vision





    Nausea, vomiting


    Confusion, extrapyramidal symptoms (EPS), dizziness, paresthesia

    Orthostatic hypotension, ECG changes, tachycardia

    Increased LFTs


    Sexual dysfunction








    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)

    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


    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.

    Doxepin hydrochloride

    capsule (generic)

    • 10mg
    • 25mg
    • 50mg
    • 75mg
    • 100mg
    • 150mg

    tablet (Silenor)

    • 3mg
    • 6mg

    oral concentrate (generic)

    • 10mg/mL


    • 5%