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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.

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

Research Report

Published: Aug 7, 2025

Trazodone (DB00656): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile

I. Introduction to Trazodone: A Multifunctional Psychotropic Agent

Trazodone is a unique psychotropic agent that occupies a distinct position in the landscape of modern pharmacotherapy. First granted approval by the U.S. Food and Drug Administration (FDA) in 1981, it is chemically classified as a triazolopyridine derivative and belongs to the pharmacological class of Serotonin Antagonist and Reuptake Inhibitors (SARIs).[1] This classification immediately signals a mechanism of action that is more complex than that of more widely known antidepressant classes, such as Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs). The central theme that defines Trazodone is its identity as a multifunctional drug, exhibiting dose-dependent pharmacology that allows it to serve disparate therapeutic roles.[2]

The drug's clinical identity is characterized by a notable dichotomy. Its sole FDA-approved indication is for the treatment of Major Depressive Disorder (MDD) in adults.[3] In this capacity, it has demonstrated efficacy comparable to that of other established antidepressants.[1] However, in contemporary clinical practice, Trazodone is more frequently prescribed for its prominent off-label use in the management of insomnia, where its sedative properties are leveraged at doses significantly lower than those required for antidepressant effects.[5] This divergence between its regulatory approval and its prevalent real-world application has created a complex clinical narrative. Many practitioners and patients have come to view Trazodone primarily as a non-addictive sleep aid, a perception that can obscure its identity as a potent antidepressant with an associated profile of significant risks, including a black box warning for suicidality and the potential for serious drug interactions.[7]

Continue reading the full research report

Clinical Trials

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FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Proficient Rx LP
63187-086
ORAL
50 mg in 1 1
1/1/2020
NuCare Pharmaceuticals,Inc.
68071-2959
ORAL
100 mg in 1 1
8/20/2025
NCS HealthCare of KY, LLC dba Vangard Labs
0615-8339
ORAL
150 mg in 1 1
8/24/2023
Cardinal Health 107, LLC
55154-8087
ORAL
50 mg in 1 1
5/19/2020
Teva Pharmaceuticals USA, Inc.
0555-0711
ORAL
300 mg in 1 1
6/30/2020
Quality Care Products, LLC
55700-739
ORAL
100 mg in 1 1
12/3/2021
Apotex Corp
60505-2653
ORAL
50 mg in 1 1
5/25/2023
Contract Pharmacy Services-PA
67046-742
ORAL
100 mg in 1 1
5/1/2009
Proficient Rx LP
71205-551
ORAL
50 mg in 1 1
4/1/2021
REMEDYREPACK INC.
70518-1204
ORAL
100 mg in 1 1
2/15/2024

EMA Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
AG-TRAZODONE
angita pharma inc.
02537915
Tablet - Oral
100 MG
4/23/2024
DESYREL TAB 100MG
bristol-myers squibb canada
00579378
Tablet - Oral
100 MG
12/31/1983
RATIO-TRAZODONE TABLETS 100MG
ratiopharm inc division of teva canada limited
02053195
Tablet - Oral
100 MG
12/31/1994
TRAZODONE
sanis health inc
02348780
Tablet - Oral
100 MG
4/30/2010
AG-TRAZODONE
angita pharma inc.
02537907
Tablet - Oral
50 MG
4/23/2024
PHL-TRAZODONE
pharmel inc
02236942
Tablet - Oral
100 MG
2/17/1998
DOM-TRAZODONE TABLETS - 50MG
dominion pharmacal
02128950
Tablet - Oral
50 MG
12/31/1996
TRAZODONE-50
PRO DOC LIMITEE
02164353
Tablet - Oral
50 MG
12/31/1996
PMS TRAZODONE HCL TAB 100MG
01937235
Tablet - Oral
100 MG
12/31/1993
PMS TRAZODONE HCL TAB 50MG
01937227
Tablet - Oral
50 MG
12/31/1993

CIMA AEMPS Drug Approvals

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Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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