SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults and obsessive-compulsive disorder (OCD) in adult and pediatric patients (ages 6-17). For MDD, the medication is used to manage persistent depressed or dysphoric moods that interfere with daily functioning, typically accompanied by symptoms such as appetite changes, sleep disturbances, psychomotor agitation/retardation, or impaired concentration. In the treatment of OCD, the drug targets obsessions and compulsions that cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
How SERTRALINE HYDROCHLORIDE Works
Sertraline is a selective serotonin reuptake inhibitor (SSRI). Its mechanism of action is primarily attributed to the potent and selective inhibition of CNS neuronal reuptake of serotonin (5-HT). This results in an enhancement of serotonergic neurotransmission. In vitro studies demonstrate that sertraline has only weak effects on norepinephrine and dopamine neuronal reuptake and lacks significant affinity for adrenergic, cholinergic, GABAergic, dopaminergic, histaminergic, or serotonergic receptors.
Details
- Status
- Prescription
- First Approved
- 2006-06-30
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, CONCENTRATE
Companies
SERTRALINE HYDROCHLORIDE Approval History
What SERTRALINE HYDROCHLORIDE Treats
1 indicationsSERTRALINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
SERTRALINE HYDROCHLORIDE Boxed Warning
BOXED WARNING Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase ...
BOXED WARNING Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride tablets are not approved for the treatment of major depressive disorder in pediatric patients. (See WARNINGS:Clinical Worsening and Suicide Risk , PRECAUTIONS:Information for Patients , and PRECAUTIONS:Pediatric Use ).
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SERTRALINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Major Depressive Disorder – Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day...
BOXED WARNING Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone consid...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.