Zoloft (Sertraline) - Drug Information, Research, Clinical Trials, News

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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 Zoloft 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. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

ZOLOFT SUMMARY

ZOLOFT^®
(sertraline hydrochloride)
Tablets and Oral Concentrate

ZOLOFT^®(sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration.

ZOLOFT is indicated for the following:

Major Depressive Disorder- ZOLOFT^®(sertraline hydrochloride) is indicated for the treatment of major depressive disorder.

Obsessive-Compulsive Disorder- ZOLOFT is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD).

Panic Disorder- ZOLOFT is indicated for the treatment of panic disorder, with or without agoraphobia.

Posttraumatic Stress Disorder (PTSD)- ZOLOFT (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder.

Premenstrual Dysphoric Disorder (PMDD) - ZOLOFT is indicated for the treatment of premenstrual dysphoric disorder (PMDD).

Social Anxiety Disorder - ZOLOFT (sertraline hydrochloride) is indicated for the treatment of social anxiety disorder, also known as social phobia.