BOXED WARNING SECTION
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients and PRECAUTIONS: Pediatric Use.)
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.
Published Studies Related to Doxepin
Doxepin rinse versus placebo in the treatment of acute oral mucositis pain in
patients receiving head and neck radiotherapy with or without chemotherapy: a
phase III, randomized, double-blind trial (NCCTG-N09C6 [Alliance]). 
reduction of radiotherapy-induced OM pain... CONCLUSION: A doxepin rinse diminishes OM pain. Further studies are warranted to
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.
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. 
elderly subjects with chronic primary insomnia... CONCLUSIONS: DXP 1 mg and 3 mg administered nightly to elderly chronic insomnia
Clinical Trials Related to Doxepin
Topical Doxepin for Radiation-induced Dermatitis [Recruiting]
Radiation dermatitis is one of the most common side effects of radiotherapy approximately
occurring in about 95% of patients receiving radiotherapy . Acute injury due to structural
tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear
and mitochondrial DNA, and initiation of an inflammatory response in the epidermis and
dermis occurs within hours to weeks after radiation exposure. Radiation dermatitis due to
pain and discomfort has an adverse impact on the quality of a patient's life. The radiation
toxicities such as radiation dermatitis encountered in clinical practice are typically
managed with a variety of topical agents such as water-based moisturizing creams or lotions,
topical steroids, antiinflammatory emulsions, and wound dressings. Pharmacologic
interventions for the prevention and treatment of these toxicity can be used to protect skin
against radiation damage. Currently, there is no standard treatment for the prevention of
radiation-induced dermatitis with demonstrated effectiveness. The aim of this randomized,
double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin
for the prevention and management of radiation-induced dermatitis during postoperative
radiotherapy for breast cancer.
Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia [Completed]
The purpose of this study is to determine the efficacy of ramelteon, once daily (QD),
combined with doxepin in treating subjects with insomnia.
Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy [Active, not recruiting]
This pilot randomized clinical trial studies the effects, good and/or bad, of taking doxepin
hydrochloride compared to placebo (inactive drug) in treating esophageal pain in patients
with thoracic cancer receiving radiation therapy to the thorax with or without chemotherapy.
Doxepin hydrochloride is a tricyclic antidepressant drug which was recently shown to be
helpful for mouth pain in patients receiving radiation therapy. Part of doxepin
hydrochloride's drug action takes place at the surface of the esophagus, which may be
helpful in reducing the pain caused by radiation therapy.
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy [Active, not recruiting]
RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in
patients undergoing radiation therapy with or without chemotherapy.
PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well
it works compared to placebo in treating oral mucositis pain in patients with head and neck
cancer undergoing radiation therapy with or without chemotherapy.
Assess the Effect of a Single Dose of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognitive Performance in Healthy Volunteers [Not yet recruiting]
This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study.
The study will assess the effects of a single dose of Silenor 6 mg compared with matching
placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the
respective T-max in normal healthy adult male volunteers. The study will be conducted in
approximately 52 male subjects
Reports of Suspected Doxepin Side Effects
Completed Suicide (34),
Toxicity TO Various Agents (21),
Cardio-Respiratory Arrest (13),
Multiple Drug Overdose Intentional (9),
Cardiac Arrest (9),
Respiratory Arrest (8),
Suicide Attempt (8), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Doxepin has an overall score of 8. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Doxepin review by 51 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || insomnia|
|Dosage & duration:|| || 75mg taken q.d. for the period of Over 1 year|
|Other conditions:|| || none|
|Other drugs taken:|| || Rozerem|
|Benefits:|| || Provides good relief from insomnia. Able to fall asleep about three hours after dosing. Average 2 awakenings during the night, but able to fall back to sleep immediately. Average 7-8 hours of sleep per night (without treatment average was 3-4 hours sleep per night with many awakenings).|
|Side effects:|| || Mild short-term memory loss|
|Comments:|| || Began with 25mg once daily 2-3 hours before bedtime, for seven days. Then 50mg once daily 2-3 hours before bedtime, for another seven days. Finally, 75mg once daily 2-3 hours before bedtime, ongoing. Drowsiness presents about 3 hours after dosing.|
Page last updated: 2014-11-30