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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/08/30 | Not Applicable | Recruiting | |||
2021/11/10 | Phase 3 | UNKNOWN | State University of New York - Upstate Medical University | ||
2021/11/04 | Not Applicable | UNKNOWN | |||
2020/10/19 | Not Applicable | Completed | Aalborg University | ||
2020/09/18 | Not Applicable | Completed | Aalborg University | ||
2019/05/09 | Not Applicable | Withdrawn | Aalborg University | ||
2018/11/29 | Phase 4 | Completed | |||
2016/09/08 | N/A | Terminated | |||
2015/05/18 | Phase 2 | UNKNOWN | |||
2015/03/02 | Phase 3 | Terminated |
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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
DEPTRAN 25 doxepin 25mg (as hydrochloride) capsule blister pack | 60448 | Medicine | A | 7/2/1997 | |
DEPTRAN 10 doxepin 10mg (as hydrochloride) capsule blister pack | 308999 | Medicine | A | 12/17/2018 | |
Deptran 50 hexagonal tablet blister pack | 17637 | Medicine | A | 9/20/1991 | |
DEPTRAN 75 tablet blister pack | 42359 | Medicine | A | 10/19/1992 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ZONALON CREAM 5% | valeant canada lp / valeant canada s.e.c. | 02142147 | Cream - Topical | 5 % / W/W | 12/31/1995 |
TRIADAPIN CAP 100MG | aventis pharma inc | 00842796 | Capsule - Oral | 100 MG / CAP | 12/31/1985 |
TRIADAPIN CAP 50MG | aventis pharma inc | 00842761 | Capsule - Oral | 50 MG / CAP | 12/31/1985 |
TRIADAPIN CAP 10MG | aventis pharma inc | 00842745 | Capsule - Oral | 10 MG / CAP | 12/31/1985 |
NTP-DOXEPIN | teva canada limited | 02348357 | Capsule - Oral | 50 MG | N/A |
TRIADAPIN CAP 75MG | aventis pharma inc | 00842788 | Capsule - Oral | 75 MG / CAP | 12/31/1985 |
NTP-DOXEPIN | teva canada limited | 02348365 | Capsule - Oral | 75 MG | N/A |
TRIADAPIN CAP 25MG | aventis pharma inc | 00842753 | Capsule - Oral | 25 MG / CAP | 12/31/1985 |
NTP-DOXEPIN | teva canada limited | 02348373 | Capsule - Oral | 100 MG | N/A |
NTP-DOXEPIN | teva canada limited | 02348349 | Capsule - Oral | 25 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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