Antidepressants have been shown to increase the risk of suicidal thinking and behavior in children, adolescents and young adults with depression and other psychiatric disorders. All patients on antidepressants and their families or caregivers should watch closely for the following, especially early during antidepressant treatment and when the dose is adjusted up or down: worsening of depression symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, and extreme hyperactivity. Such symptoms may be associated with an increased risk of suicidal thinking and behavior and should be reported to the patient's healthcare professional right away, especially if they are severe or occur suddenly. EMSAM is not approved for use in pediatric patients. Furthermore, EMSAM at any dose should not be used in children under the age of 12, even when administered with dietary modifications.