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)