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
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]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2015/06/01 | Phase 2 | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/04/21 | Phase 4 | Withdrawn | |||
2014/03/13 | Phase 3 | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | ||
2013/07/11 | Not Applicable | UNKNOWN | |||
2013/03/26 | Not Applicable | Completed | |||
2013/01/10 | Phase 4 | UNKNOWN | |||
2012/08/10 | Phase 4 | Terminated | VA Connecticut Healthcare System | ||
2012/07/27 | Not Applicable | Completed | Jack Edinger, PhD | ||
2012/02/02 | Phase 2 | Completed | Lee's Pharmaceutical Limited |
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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HSA Drug Approvals
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NMPA Drug Approvals
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PPB 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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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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