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Doxepin

Generic Name
Doxepin
Brand Names
Prudoxin, Silenor, Sinequan, Zonalon
Drug Type
Small Molecule
Chemical Formula
C19H21NO
CAS Number
1668-19-5
Unique Ingredient Identifier
5ASJ6HUZ7D
Background

Doxepin is a psychotropic agent with antidepressant and anxiolytic properties. It is a tertiary amine that can be presented as (E) and (Z) stereoisomers with the (Z) stereoisomer corresponding to cidoxepin. Doxepin commonly produces a 5:1 (E):(Z) racemic mixture.

In a strict sense, doxepin is not a tricyclic antidepressant but it is commonly associated with the class since it shares a lot of properties with members of the drug family including amitriptyline, clomipramine, desipramine, imipramine, nortriptyline, protriptyline and trimipramine.

Doxepin was developed by Pfizer and FDA approved in 1969 as an antidepressant. However, in 2010 it was approved for the treatment of insomnia. The latter indication was presented by Pernix Therapeutics.

Indication

Oral doxepin is approved for the following indications:

Topical doxepin is also approved for short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis, pruritus or lichen simplex chronicus.

Off-label, doxepin is used topically for the management of neuropathic pain.

Depression is a common medical illness that causes feelings of sadness and or loss of interest in prior enjoyable activities. This condition can lead to emotional and physical disturbances that can decrease the ability of a person to function in a regular environment.

Anxiety is a normal reaction of the body towards a normal danger. When the anxious state is exacerbated or appears on situations without danger, it is defined as an anxiety disorder. This disorders can appear in different forms such as phobias, panic, obsessive-compulsive disorder and post-traumatic stress disorder.

Insomnia is a sleep disorder that directly affects the quality of life of the individual. It is characterized by the complication either to fall asleep or to stay asleep. This condition can be occasional or chronic.

Pruritus is defined as an unpleasant skin reaction that provokes the urge to scratch. It can be localized or generalized and it can appear in an acute or chronic manner.

Neuropathic pain occurs due to the damage or dysfunction of the peripheral or central nervous system rather than stimulation of the pain receptors.

Associated Conditions
Anxiety, Bipolar Disorder (BD), Depression, Depression, Involutional, Insomnia, Lichen simplex chronicus, Neuropathic Pain, Neurotic depression, Pruritus, Psychotic depressive disorder

Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma

Not Applicable
Recruiting
Conditions
Swallowing-induced Pain
Interventions
First Posted Date
2023-08-30
Last Posted Date
2024-12-27
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
178
Registration Number
NCT06017895
Locations
🇨🇳

Southern medical university, Guangzhou, Guangdong, China

Using Doxepin for Urticaria

Phase 3
Conditions
Urticaria
Interventions
First Posted Date
2021-11-10
Last Posted Date
2022-05-18
Lead Sponsor
State University of New York - Upstate Medical University
Target Recruit Count
160
Registration Number
NCT05115136
Locations
🇺🇸

SUNY Upstate Medical University, Syracuse, New York, United States

Stigma and Efficacy of Zhizhu Kuanzhong Capsules

Not Applicable
Conditions
Functional Gastrointestinal Disorders
Dyspepsia
Psychosomatic Disorder
Interventions
Drug: Zhizhu Kuanzhong capsules (ZZKZ)
First Posted Date
2021-11-04
Last Posted Date
2022-08-10
Lead Sponsor
RenJi Hospital
Target Recruit Count
76
Registration Number
NCT05107999
Locations
🇨🇳

Renji Hospital, Shanghai, Shanghai, China

Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch

Not Applicable
Completed
Conditions
Itch
Interventions
Drug: Cowhage (Mucuna Pruriens)
First Posted Date
2020-10-19
Last Posted Date
2021-07-21
Lead Sponsor
Aalborg University
Target Recruit Count
24
Registration Number
NCT04588532
Locations
🇩🇰

Aalborg University, Aalborg, Denmark

Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor

Not Applicable
Completed
Conditions
Itch
Interventions
First Posted Date
2020-09-18
Last Posted Date
2022-07-20
Lead Sponsor
Aalborg University
Target Recruit Count
20
Registration Number
NCT04554888
Locations
🇩🇰

Aalborg University, Aalborg, Nordjylland, Denmark

Characterization of the Toll-like Receptor 7-agonist Imiquimod 3.75% As a New Surrogate Model of Itch

Not Applicable
Withdrawn
Conditions
Itch
Interventions
Other: Histamine
Other: L-menthol
Other: Cowhage
Other: Trans-cinnamaldehyde (CA)
First Posted Date
2019-05-09
Last Posted Date
2024-11-22
Lead Sponsor
Aalborg University
Registration Number
NCT03943407
Locations
🇩🇰

Aalborg University, Aalborg, Nordjylland, Denmark

Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

Phase 4
Completed
Conditions
Uremic Pruritus
Interventions
First Posted Date
2018-11-29
Last Posted Date
2018-11-29
Lead Sponsor
University of Balamand
Target Recruit Count
14
Registration Number
NCT03758079
Locations
🇱🇧

Saint George Hospital University Medical Center, Beirut, Lebanon

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated
Conditions
Bipolar Disorder
First Posted Date
2016-09-08
Last Posted Date
2024-03-12
Lead Sponsor
University of New Mexico
Target Recruit Count
1037352
Registration Number
NCT02893371
Locations
🇺🇸

Christophe G Lambert, Albuquerque, New Mexico, United States

Topical Doxepin for Radiation-induced Dermatitis

Phase 2
Conditions
Breast Cancer
Interventions
First Posted Date
2015-05-18
Last Posted Date
2019-01-16
Lead Sponsor
Isfahan University of Medical Sciences
Target Recruit Count
60
Registration Number
NCT02447211
Locations
🇮🇷

Isfahan University of Medical Sciences, Isfahan, Iran, Islamic Republic of

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations
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