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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Phase 4 | Not yet recruiting | Xinyu Zhou | ||
2025/02/21 | Not Applicable | Active, not recruiting | Nishtar Medical University | ||
2025/02/14 | Phase 3 | Not yet recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2025/01/16 | Not Applicable | Recruiting | Hualien Tzu Chi General Hospital | ||
2024/12/10 | Not Applicable | Completed | Lin Xiaoqian | ||
2024/11/26 | Phase 4 | Recruiting | |||
2024/11/21 | Phase 3 | Recruiting | |||
2024/05/10 | Phase 2 | Not yet recruiting | |||
2024/04/25 | Not Applicable | Not yet recruiting | |||
2024/04/10 | Phase 4 | Completed | Pachankis, Yang I., M.D. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 68071-4750 | ORAL | 25 mg in 1 1 | 2/17/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4993 | ORAL | 50 mg in 1 1 | 2/19/2021 | |
| Greenstone LLC | 59762-6347 | ORAL | 25 mg in 1 1 | 4/7/2022 | |
| Mylan Pharmaceuticals Inc. | 59762-6347 | ORAL | 25 mg in 1 1 | 4/7/2022 | |
| Greenstone LLC | 59762-6443 | ORAL | 50 mg in 1 1 | 4/7/2022 | |
| Mylan Pharmaceuticals Inc. | 59762-6443 | ORAL | 50 mg in 1 1 | 4/7/2022 | |
| XLCare Pharmaceuticals, Inc. | 72865-206 | ORAL | 50 mg in 1 1 | 6/30/2023 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0310 | ORAL | 100 mg in 1 1 | 4/7/2023 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7989 | ORAL | 25 mg in 1 1 | 7/20/2023 | |
| Zydus Lifesciences Limited | 65841-045 | ORAL | 100 mg in 1 1 | 9/27/2023 |
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 |
|---|---|---|---|---|---|
| ZOLOFT TABLET 50 mg | SIN07301P | TABLET, FILM COATED | 50 mg | 11/6/1992 | |
| INOSERT 100 Tablet 100mg | SIN14789P | TABLET, FILM COATED | 100mg | 5/26/2015 | |
| SERNADE FILM-COATED TABLET 50 MG | SIN16649P | TABLET, FILM COATED | 50 mg | 12/1/2022 | |
| SETROF TABLET 50MG | SIN14221P | TABLET, FILM COATED | 50mg | 9/5/2012 | |
| Apo-Sertraline 50mg Tablet | SIN13467P | TABLET, FILM COATED | 50.0 mg | 5/15/2008 | |
| ACOLOFT 50 SERTRALINE FILM COATED TABLET BP 50 MG | SIN16385P | TABLET, FILM COATED | 50 mg | 11/25/2021 | |
| INOSERT 50 TABLET 50mg | SIN14790P | TABLET, FILM COATED | 50 mg | 5/26/2015 | |
| Apo-Sertraline 50mg Capsule | SIN13315P | CAPSULE | 50mg | 7/16/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sertraline Hydrochloride Dispersible Tablets | 国药准字H20090337 | 化学药品 | 片剂 | 4/29/2024 | |
| Sertraline Hydrochloride Dispersible Tablets | 国药准字H20100046 | 化学药品 | 片剂 | 1/22/2020 | |
| Sertraline Hydrochloride Capsules | 国药准字H20051830 | 化学药品 | 胶囊剂 | 4/17/2020 | |
| Sertraline Hydrochloride Capsules | 国药准字H20080291 | 化学药品 | 胶囊剂 | 11/14/2022 | |
| Sertraline Hydrochloride Capsules | 国药准字H20050834 | 化学药品 | 胶囊剂 | 3/17/2020 | |
| Sertraline Hydrochloride Capsules | 国药准字H20052648 | 化学药品 | 胶囊剂 | 7/28/2020 | |
| Sertraline Hydrochloride Capsules | 国药准字H20070179 | 化学药品 | 胶囊剂 | 5/10/2022 | |
| Sertraline Hydrochloride Tablets | 国药准字H20143062 | 化学药品 | 片剂 | 8/23/2023 | |
| Sertraline Hydrochloride Tablets | 国药准字H20060364 | 化学药品 | 片剂 | 4/3/2020 | |
| Sertraline Hydrochloride Tablets | 国药准字H20051791 | 化学药品 | 片剂 | 9/3/2024 |
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 |
|---|---|---|---|---|---|
| SETRONA sertraline (as hydrochloride) 50 mg tablet blister pack | 116623 | Medicine | A | 6/22/2006 | |
| SERTRALINE SANDOZ sertraline hydrochloride 100mg tablet blister pack | 98698 | Medicine | A | 12/15/2003 | |
| SERTRALINE SANDOZ sertraline hydrochloride 50mg tablet blister pack | 98697 | Medicine | A | 12/15/2003 | |
| APO-SERTRALINE sertraline (as hydrochloride) 100mg tablet blister pack | 213180 | Medicine | A | 9/27/2013 | |
| APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack | 213177 | Medicine | A | 9/27/2013 | |
| Sertraline-TIH sertraline (as hydrochloride) 50 mg tablet blister pack | 213178 | Medicine | A | 9/27/2013 | |
| APOTEX-SERTRALINE sertraline (as hydrochloride) 50 mg tablet blister | 150243 | Medicine | A | 8/15/2008 | |
| SERTRALINE SANDOZ sertraline (as hydrochloride) 100 mg film coated tablet bottle | 98696 | Medicine | A | 12/15/2003 | |
| SERTRALINE-WGR sertraline (as hydrochloride) 100mg tablet blister pack | 195320 | Medicine | A | 2/12/2013 | |
| SERTRA 50 sertraline (as hydrochloride) 50 mg tablet blister pack | 107067 | Medicine | A | 8/4/2005 |