Doxepin (Doxepin Hydrochloride) - Summary

DOXEPIN SUMMARY

DOXEPIN HYDROCHLORIDE CAPSULES, USP

Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds.

Doxepin is indicated for the following:

Doxepin is recommended for the treatment of:

1. Psychoneurotic patients with depression and/or anxiety.
2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.

The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.

Clinical experience has shown that doxepin is safe and well-tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.

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NEWS HIGHLIGHTS

Published Studies Related to Doxepin

Low-dose doxepin for treatment of pruritus in patients on hemodialysis. [2007.07]
INTRODUCTION. Pruritus is one of the frequent discomforting complications in patients with end-stage renal disease.A low dose of doxepin is safe while effective and its main adverse effect, drowsiness, is temporary and can be easily tolerated by the patients.

A randomized controlled clinical trial comparing "guideline exposed" and "guideline naive" physicians in respect to dosage selection and treatment outcome with doxepin in depressive disorders. [2007.03]
CONCLUSION: Guideline exposure did not reach its goal in respect to the recommended dosage. It missed its goal in respect to improvement of outcome and even showed negative effects. Guidelines should be evidence-based not only by referring to literature reviews but by testing their clinical effects in controlled clinical trials.

Cetirizine, doxepine, and hydroxyzine in the treatment of pruritus due to sulfur mustard: a randomized clinical trial. [2007]
A 4-week randomized, double-blind safety and efficacy study was conducted to compare the safety and efficacy of cetirizine, doxepine, and hydroxyzine 5 in the treatment of chronic pruritus due to sulfur mustard. Patients were treated in the Dermatology Clinic of Baqiyatallah Hospital... Hydroxyzine 25 mg/day has equal results compared to doxepine 10 mg once daily; but greater than cetirizine 10 mg once a day in controlling the symptoms of patients with chronic pruritus.

The sleep-improving effects of doxepin are paralleled by a normalized plasma cortisol secretion in primary insomnia. A placebo-controlled, double-blind, randomized, cross-over study followed by an open treatment over 3 weeks. [2003.12]
RATIONALE: In primary care, sedating antidepressants are often used for treating insomnia, although their underlying sleep-promoting mechanisms are only incompletely understood. Since enhanced evening and nocturnal plasma cortisol levels are supposed to maintain insomniac sleep complaints, a functional link between sleep and cortisol secretion in the mode of action of antidepressants in insomnia might be suspected. OBJECTIVES: We therefore investigated the effects of the tricyclic antidepressant doxepin on nocturnal sleep and plasma cortisol concentration in ten patients (age 41.3+/-9.5 years) with chronic primary insomnia between 1700 hours and 0800 hours... CONCLUSIONS: The results implicate that the sleep-improving effects of doxepin are mediated at least in part by a normalization of hypothalamic-pituitary-adrenal axis functions. Although in some patients rebound insomnia and specific side effects must be considered, our findings give a further rationale for the use of antidepressants in the treatment of primary insomnia.

Absolute bioavailability and stereoselective pharmacokinetics of doxepin. [2002.07]
1.After oral dosing, plasma concentrations of the doxepin isomers remained roughly in the ratio Z:E = 15:85, whereas those of N-desmethyldoxepin were closer to 1:1 in all but two outliers, who had high levels E-N-desmethyldoxepin.

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Clinical Trials Related to Doxepin

The Treatment of Insomnia in Patients With HIV Disease [Recruiting]
This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.

Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism [Recruiting]
Reduction of volume of the hippocampus has been associated with major depression in many studies. It has been suggested that antidepressants may protect against hippocampus volume loss in humans associated with multiple episodes of depression and may also reverse the reduction of volume caused by the depression. In addition, genetic markers for serotonin are implicated with depression, and may be an indication of reduced response to antidepressant treatments.

This study aims to enroll patients who are defined as having treatment resistant depression (no remission after at least 2 treatments trials with an antidepressant). They will receive an MRI scan at the initial visit and either 6 months after sustained remission or 12 months after they enter the study for non-remitters. They will also be asked to give a blood sample for genotyping. They will be matched by age and handedness to healthy volunteers with no personal history of depression who will also receive an MRI scan and genotyping.

The first aim is to compare hippocampal volume of depressed subjects to healthy controls. It is anticipated that subjects will initially have smaller hippocampal volume but of those who sustain remission, there will be a small increase in hippocampal volume. It is also anticipated that specific genetic markers will be related to individuals response to antidepressant treatments.

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