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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/08/09 | Early Phase 1 | Not yet recruiting | |||
2024/02/29 | Phase 1 | Recruiting | |||
2024/02/28 | Early Phase 1 | Recruiting | |||
2022/04/01 | N/A | Recruiting | |||
2022/03/29 | Phase 1 | Withdrawn | Verinder Sharma | ||
2022/03/24 | Phase 1 | Recruiting | |||
2022/03/16 | Phase 2 | Recruiting | |||
2022/01/26 | Phase 4 | Active, not recruiting | |||
2021/11/29 | Phase 1 | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | ||
2021/11/18 | Not Applicable | Recruiting | Dr. Nazanin Alavi |
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 |