doxepin hydrochloride

DOXEPIN HYDROCHLORIDE

Manufacturer: Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven

Score: 141.0

Quick Summary

Doxepin hydrochloride is a tricyclic antidepressant used for the treatment of insomnia characterized by difficulty with sleep maintenance. The recommended dose is 6 mg once daily for adults and 3 mg once daily for the elderly, taken within 30 minutes of bedtime. Doxepin has high binding affinity to the H1 receptor and is extensively metabolized by hepatic enzymes. It is contraindicated in individuals with hypersensitivity to doxepin, untreated narrow angle glaucoma, or severe urinary retention. Common adverse reactions include somnolence, nausea, and upper respiratory tract infection. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of insomnia characterized by difficulty with sleep maintenance
High binding affinity to the H1 receptor
Extensively metabolized by hepatic enzymes

Important Safety Information

Warning

May cause abnormal thinking and behavioral changes, suicide risk, and worsening of depression

Contraindications

Hypersensitivity to doxepin hydrochloride
Untreated narrow angle glaucoma
Severe urinary retention
Co-administration with Monoamine Oxidase Inhibitors (MAOIs)

Adverse Reactions

Somnolence
Nausea
Upper respiratory tract infection
Dizziness
Dry mouth

Dosing Recommendations

General Guidance

Total daily dose should not exceed 6 mg

Insomnia

Adult Dose

6 mg once daily

Pediatric Dose

Not evaluated

Insomnia in elderly

Adult Dose

3 mg once daily

Pediatric Dose

Not evaluated

Special Population Considerations

Pregnancy

Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage
Risks of poor neonatal adaptation with exposure to tricyclic antidepressants during pregnancy

Nursing Mothers

Doxepin may reduce fertility in females and males of reproductive potential
It is unknown if the effects are reversible

Pediatric Use

The safety and effectiveness of doxepin in pediatric patients have not been evaluated

Geriatric Use

A starting dose of 3 mg is recommended in this population
Evaluation prior to considering dose escalation is recommended

Similar Drugs

Doxorubicin Hydrochloride

DOXORUBICIN

Amneal Pharmaceuticals LLC

Similarity: 70.5%

Duloxetine hydrochloride

DULOXETIN HYDROCHLORIDE

Torrent Pharmaceuticals Limited

Similarity: 63.7%

Venlafaxine Hydrochloride

VENLAFAXINE HYDROCHLORIDE

A-S Medication Solutions

Similarity: 62.7%