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
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | ||
2011/11/09 | Phase 3 | Completed | Targeted Medical Pharma |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
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 | 3/27/2023 | |
| 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
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||