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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

Overview

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.

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

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
JUBILANT CADISTA PHARMACEUTICALS INC.
59746-700
ORAL
10 mg in 1 1
12/13/2021
Par Pharmaceutical, Inc.
49884-220
ORAL
75 mg in 1 1
10/5/2022
NORTHSTAR RX LLC
16714-133
ORAL
25 mg in 1 1
10/21/2020
Contract Pharmacal Corp.
10267-5059
ORAL
10 mg in 1 1
8/6/2020
Edenbridge Pharmaceuticals LLC.
42799-935
ORAL
150 mg in 1 1
5/26/2022
Ajanta Pharma USA Inc.
27241-168
ORAL
25 mg in 1 1
11/24/2021
REMEDYREPACK INC.
70518-3494
ORAL
75 mg in 1 1
1/12/2024
DIRECT RX
61919-081
ORAL
50 mg in 1 1
8/5/2015
Novadoz Pharmaceuticals LLC
72205-092
ORAL
100 mg in 1 1
1/2/2020
Florida Pharmaceutical Products, LLC
71921-162
ORAL
10 mg in 1 1
9/24/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Doxepin Hydrochloride Tablets
国药准字H14020311
化学药品
片剂
8/13/2020
Doxepin Hydrochloride Tablets
国药准字H37020217
化学药品
片剂
4/17/2020
Doxepin Hydrochloride Tablets
国药准字H32022317
化学药品
片剂
7/28/2020
Doxepin Hydrochloride Tablets
国药准字H32023097
化学药品
片剂
7/14/2020
Doxepin Hydrochloride Tablets
国药准字H32025206
化学药品
片剂
7/14/2020
Doxepin Hydrochloride Tablets
国药准字H31021425
化学药品
片剂(糖衣)
12/27/2019
Doxepin Hydrochloride Tablets
国药准字H11020850
化学药品
片剂
6/1/2020
Doxepin Hydrochloride Tablets
国药准字H64020138
化学药品
片剂
12/18/2019
Doxepin Hydrochloride Tablets
国药准字H31020447
化学药品
片剂
5/28/2024
Doxepin Hydrochloride Tablets
国药准字H32022163
化学药品
片剂
7/30/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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