Doxepin

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).

Hypersensitivity

Untreated narrow-angle glaucoma

Severe urinary retention

Within 14 days of MAO inhibitors

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

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

Adults

For the capsules and solution, 300 mg/day PO; for the tablets (Silenor), 6 mg/day PO.

Geriatric

For the capsules and solution, 300 mg/day PO; for the tablets (Silenor), 6 mg/day PO.

Adolescents

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.

Children

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

cream

  • 5%

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