ZONALON SUMMARY
ZONALON® (doxepin hydrochloride) CREAM, 5%
Zonalon® (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[ b,e ]oxepin-Δ11(6H),γ-propylamine hydrochloride.
Zonalon® Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.)
|
NEWS HIGHLIGHTS
Published Studies Related to Zonalon (Doxepin Topical)
Efficacy and safety of doxepin 3 and 6 mg in a 35-day sleep laboratory trial in adults with chronic primary insomnia. [2011.10.01]
STUDY OBJECTIVES: To evaluate the efficacy and safety of doxepin (DXP) 3 mg and 6 mg in adults diagnosed with primary insomnia... CONCLUSIONS: Five weeks of nightly administration of DXP 3 mg and 6 mg to adults with chronic primary insomnia resulted in significant and sustained improvements in sleep maintenance and early morning awakenings (with the exception of SE in the final quarter of the night on N29 for 3 mg [P=0.0691]). These sleep improvements were not accompanied by next-day residual effects or followed by rebound insomnia or withdrawal effects upon discontinuation. These findings confirm the unique profile of sleep maintenance efficacy and safety of DXP observed in prior studies.
Doxepin cream vs betamethasone cream for treatment of chronic skin lesions due to sulfur mustard. [2011.05]
Oral doxepin was shown to reduce chronic pruritus due to sulfur mustard. The present study compared the effects of topical doxepin 5% with betamethasone 1% for the treatment of pruritus in veterans exposed to sulfur mustard...
Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia. [2010.11]
STUDY OBJECTIVES: to evaluate the efficacy and safety of doxepin 1 mg and 3 mg in elderly subjects with chronic primary insomnia... CONCLUSIONS: DXP 1 mg and 3 mg administered nightly to elderly chronic insomnia patients for 12 weeks resulted in significant and sustained improvements in most endpoints. These improvements were not accompanied by evidence of next-day residual sedation or other significant adverse effects. DXP also demonstrated improvements in both patient- and physician-based ratings of global insomnia outcome. The efficacy of DXP at the doses used in this study is noteworthy with respect to sleep maintenance and early morning awakenings given that these are the primary sleep complaints of the elderly. This study, the longest placebo-controlled, double-blind, polysomnographic trial of nightly pharmacotherapy for insomnia in the elderly, provides the best evidence to date of the sustained efficacy and safety of an insomnia medication in older adults.
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.
Clinical Trials Related to Zonalon (Doxepin Topical)
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.
|
