Overview
Sertraline is a popular antidepressant medication commonly known as a selective serotonin reuptake inhibitor (SSRI), and is similar to drugs such as Citalopram and Fluoxetine. Despite marked structural differences between compounds in this drug class, SSRIs exert similar pharmacological effects. Several weeks of therapy with sertraline may be required before beneficial effects are noticed. Sertraline displays enhanced safety or tolerability than other classes of antidepressants, which frequently cause high levels of drowsiness, dizziness, blurred vision, and other undesirable effects.
Background
Sertraline is a popular antidepressant medication commonly known as a selective serotonin reuptake inhibitor (SSRI), and is similar to drugs such as Citalopram and Fluoxetine. Despite marked structural differences between compounds in this drug class, SSRIs exert similar pharmacological effects. Several weeks of therapy with sertraline may be required before beneficial effects are noticed. Sertraline displays enhanced safety or tolerability than other classes of antidepressants, which frequently cause high levels of drowsiness, dizziness, blurred vision, and other undesirable effects.
Indication
Sertraline is indicated for the management of major depressive disorder (MDD), post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), panic disorder (PD), premenstrual dysphoric disorder (PMDD), and social anxiety disorder (SAD). Common off-label uses for sertraline include the prevention of post stroke depression, generalized anxiety disorder (GAD), fibromyalgia, premature ejaculation, migraine prophylaxis, diabetic neuropathy, and neurocardiogenic syncope.
Associated Conditions
- Binge Eating Disorder (BED)
- Bulimia Nervosa
- Generalized Anxiety Disorder
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Post Traumatic Stress Disorder (PTSD)
- Premenstrual Dysphoric Disorder (PMDD)
- Social Anxiety Disorder (SAD)
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 |
---|---|---|---|---|---|
2016/06/27 | Not Applicable | Terminated | |||
2016/06/13 | Phase 1 | Completed | |||
2016/05/19 | Phase 4 | Completed | |||
2016/05/12 | Phase 1 | Completed | University of Ulm | ||
2016/01/14 | Not Applicable | Completed | |||
2016/01/11 | Phase 1 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||
2015/12/29 | Phase 4 | UNKNOWN | University Hospital Olomouc | ||
2015/10/01 | Phase 2 | Completed | |||
2015/08/13 | Phase 4 | Terminated | |||
2015/07/22 | Phase 4 | Completed |
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 |
---|---|---|---|---|---|
Bryant Ranch Prepack | 71335-0896 | ORAL | 100 mg in 1 1 | 1/19/2022 | |
Bryant Ranch Prepack | 71335-0510 | ORAL | 100 mg in 1 1 | 9/15/2021 | |
Unit Dose Services | 50436-0011 | ORAL | 25 mg in 1 1 | 1/9/2019 | |
RPK Pharmaceuticals, Inc. | 53002-3215 | ORAL | 100 mg in 1 1 | 3/13/2023 | |
NuCare Pharmaceuticals,Inc. | 68071-4400 | ORAL | 50 mg in 1 1 | 1/17/2022 | |
Exelan Pharmaceuticals, Inc. | 76282-212 | ORAL | 25 mg in 1 1 | 9/1/2023 | |
QPharma Inc | 42708-124 | ORAL | 50 mg in 1 1 | 8/11/2023 | |
NuCare Pharmaceuticals,Inc. | 68071-4462 | ORAL | 25 mg in 1 1 | 2/22/2021 | |
REMEDYREPACK INC. | 70518-1040 | ORAL | 100 mg in 1 1 | 2/14/2024 | |
Camber Pharmaceuticals, Inc. | 31722-146 | ORAL | 50 mg in 1 1 | 6/22/2023 |
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. |