Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (aged 18-24) with major depressive disorder (MDD) and other psychiatric disorders. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. One-fourth of responders required 2-4 weeks for a significant therapeutic response. Three-fourths of all responders demonstrated a significant therapeutic effect by the end of the second week. Following co-administration of carbamazepine 400 mg/day with trazodone 100 mg to 300 mg daily, carbamazepine reduced plasma concentrations of trazodone (as well as mCPP) by 76 and 60%, respectively, compared to pre-carbamazepine values.įor those patients who responded to trazodone HCl, one-third of the inpatients and one-half of the outpatients had a significant therapeutic response by the end of the first week of treatment. Adverse effects including nausea, hypotension, and syncope were observed when ritonavir and trazodone were co-administered.Ĭarbamazepine induces CYP34A. The Cmax of trazodone increased by 34%, the AUC increased 2.4-fold, the half-life increased by 2.2-fold, and the clearance decreased by 52%. The effect of short-term administration of ritonavir (200 mg twice daily, 4 doses) on the pharmacokinetics of a single dose of trazodone (50 mg) has been studied in 10 healthy subjects. In vitro drug metabolism studies reveal that trazodone is a substrate of the cytochrome P450 3A4 (CYP3A4) enzyme and trazodone metabolism can be inhibited by the CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use Trazodone HCl is not approved for use in pediatric patients. Families and caregivers should be advised of the need for close observation and communication with the prescriber. 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. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Anyone considering the use of trazodone HCl or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 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.
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