MedPath

Trazodone

Generic Name
Trazodone
Brand Names
Desyrel, Oleptro
Drug Type
Small Molecule
Chemical Formula
C19H22ClN5O
CAS Number
19794-93-5
Unique Ingredient Identifier
YBK48BXK30

Overview

Trazodone is triazolopyridine derivative from the serotonin receptor antagonists and reuptake inhibitors (SARIs) class of antidepressants. It is used in adults and has been shown to be comparable in efficacy to other drugs such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and serotonin-norepinephrine receptor inhibitor (SNRIs) in the treatment of depression. A unique feature of this drug is that it does not promote the anxiety symptoms, sexual symptoms, or insomnia, which are commonly associated with SSRI and SNRI therapy. Trazodone acts on various receptors, including certain histamine, serotonin, and adrenergic receptors, distinguishing it from other antidepressants that cover a narrow range of neurotransmitters. It was initially granted FDA approval in 1981.

Background

Trazodone is triazolopyridine derivative from the serotonin receptor antagonists and reuptake inhibitors (SARIs) class of antidepressants. It is used in adults and has been shown to be comparable in efficacy to other drugs such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and serotonin-norepinephrine receptor inhibitor (SNRIs) in the treatment of depression. A unique feature of this drug is that it does not promote the anxiety symptoms, sexual symptoms, or insomnia, which are commonly associated with SSRI and SNRI therapy. Trazodone acts on various receptors, including certain histamine, serotonin, and adrenergic receptors, distinguishing it from other antidepressants that cover a narrow range of neurotransmitters. It was initially granted FDA approval in 1981.

Indication

Trazodone is indicated for the treatment of major depressive disorder (MDD). It has been used off-label for adjunct therapy in alcohol dependence, and off-label to treat anxiety and insomnia. It may also be used off-label to treat symptoms of dementia, Alzheimer’s disease, schizophrenia, eating disorders, and fibromyalgia due to its effects on various neurotransmitter receptors.

Associated Conditions

  • Alcohol Dependency
  • Alzheimer's Disease (AD)
  • Anxiety
  • Dementia
  • Eating Disorders Symptoms
  • Fibromyalgia
  • Insomnia
  • Major Depressive Disorder (MDD)
  • Pain, Inflammatory
  • Schizophrenia
  • Moderate to severe pain

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NCS HealthCare of KY, LLC dba Vangard Labs
0615-8371
ORAL
50 mg in 1 1
8/24/2023
Granules Pharmaceuticals Inc.
70010-232
ORAL
100 mg in 1 1
3/24/2025
STAT Rx USA LLC
42549-546
ORAL
50 mg in 1 1
3/9/2011
Contract Pharmacy Services-PA
67046-741
ORAL
100 mg in 1 1
6/1/2009
Asclemed USA, Inc.
76420-648
ORAL
100 mg in 1 1
2/26/2024
Quality Care Products, LLC
55700-855
ORAL
100 mg in 1 1
9/16/2021
A-S Medication Solutions
50090-6603
ORAL
50 mg in 1 1
10/8/2022
Apotex Corp
60505-2659
ORAL
300 mg in 1 1
5/25/2023
American Health Packaging
60687-454
ORAL
100 mg in 1 1
9/7/2023
NuCare Pharmaceuticals,Inc.
68071-5187
ORAL
50 mg in 1 1
2/7/2022

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
TRITTICO TABLETS 50 mg
SIN10777P
TABLET, FILM COATED
50 mg
2/26/1999

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Trazodone Hydrochloride Sustained-release Tablets
az.chim.riun.angelini francesco acraf s.p.a.
国药准字HJ20200052
化学药品
片剂
12/2/2020
Trazodone Hydrochloride Sustained-release Tablets
az.chim.riun.angelini francesco acraf s.p.a.
国药准字HJ20200051
化学药品
片剂
12/2/2020
Trazodone Hydrochloride Tablets
国药准字HC20191000
化学药品
片剂
10/20/2020
Trazodone Hydrochloride Tablets
国药准字H20031077
化学药品
片剂
8/17/2020
Trazodone Hydrochloride Tablets
国药准字H20060037
化学药品
片剂
5/29/2020
Trazodone Hydrochloride Tablets
国药准字HC20171014
化学药品
片剂
10/20/2020
Trazodone Hydrochloride Tablets
国药准字H20050223
化学药品
片剂
5/12/2020
Trazodone Hydrochloride Tablets
国药准字H20020355
化学药品
片剂
8/17/2020
Trazodone Hydrochloride Tablets
国药准字H20133205
化学药品
片剂
5/29/2020
Trazodone Hydrochloride Tablets
国药准字H20254458
化学药品
片剂
6/3/2025

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
Trazodone Hydrochloride 50mg capsule Bulk
263393
Medicine
A
11/17/2015
TRAZODONE HYDROCHLORIDE 150mg tablet bulk (AF)
80962
Medicine
A
11/16/2001
Trazodone Hydrochloride 100mg capsule Bulk
263394
Medicine
A
11/17/2015
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