What is the use of Sertraline (Selective Serotonin Reuptake Inhibitor) in pediatric patients?

From the Guidelines

Sertraline can be used in children for anxiety disorders, but it should be prescribed with caution due to potential side effects, including suicidal thinking and behavior, and requires close monitoring, especially in the first few months of treatment. When considering the use of sertraline in children, it is essential to weigh the potential benefits against the risks, as outlined in the clinical practice guideline for the assessment and treatment of children and adolescents with anxiety disorders 1.

Key Considerations

• The guideline recommends slow up-titration of sertraline to avoid unintentionally exceeding the optimal medication dose, as the best-fitting model for SSRI response may be a logarithmic model demonstrating statistically significant improvement in anxiety symptoms within 2 weeks of treatment initiation, clinically significant improvement by week 6, and maximal improvement by week 12 or later 1.
• Children and adolescents taking sertraline may experience common side effects, including dry mouth, nausea, diarrhea, heartburn, headache, somnolence, insomnia, dizziness, vivid dreams, changes in appetite, weight loss or gain, fatigue, nervousness, tremor, bruxism, and diaphoresis 1.
• Potentially serious adverse effects include suicidal thinking and behavior, behavioral activation/agitation, hypomania, mania, sexual dysfunction, seizures, abnormal bleeding, and serotonin syndrome, which can be triggered by combining serotonergic medications 1.

Monitoring and Education

• Close monitoring for suicidality is recommended, especially in the first months of treatment and following dosage adjustments, as the pooled absolute rates for suicidal ideation across all antidepressant classes and all non-OCD anxiety indications have been reported to be 1% for youths treated with an antidepressant and 0.2% for youths treated with a placebo 1.
• Parents/guardians and patients should be educated in advance about the potential side effects of sertraline, including behavioral activation/agitation, and the importance of reporting concerning behavioral changes immediately to their healthcare provider 1.

Treatment Duration

• Treatment duration with sertraline typically lasts 6-12 months after symptom resolution for anxiety disorders, and parents should be aware of the potential need for long-term treatment and monitoring 1.

From the FDA Drug Label

The efficacy of sertraline for the treatment of obsessive-compulsive disorder was demonstrated in a 12-week, multicenter, placebo-controlled study with 187 outpatients ages 6 to 17 Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established Approximately 600 patients with major depressive disorder or OCD between 6 and 17 years of age have received sertraline in clinical trials, both controlled and uncontrolled. The adverse event profile observed in these patients was generally similar to that observed in adult studies with sertraline Anyone considering the use of sertraline in a child or adolescent must balance the potential risks with the clinical need The safety of sertraline use in children and adolescents with OCD, ages 6 to18, was evaluated in a 12-week, multicenter, placebo-controlled study with 187 outpatients, ages 6 to 17

Sertraline use in children is approved only for patients with obsessive compulsive disorder (OCD).

• The safety and effectiveness of sertraline in pediatric patients with other conditions have not been established.
• Clinical trials have shown that sertraline can be effective in treating OCD in children and adolescents, but the adverse event profile is similar to that observed in adults.
• Monitoring of weight and growth is recommended if treatment of a pediatric patient with sertraline is to be continued long term.
• The risks associated with sertraline’s use beyond 1 year in children and adolescents with OCD or major depressive disorder have not been systematically assessed 2, 2, 2

From the Research

Sertraline in Children: Efficacy and Safety

• Sertraline has been studied in children and adolescents for the treatment of various conditions, including obsessive-compulsive disorder (OCD), depression, and posttraumatic stress disorder (PTSD) 3, 4, 5.
• A study published in 1998 found that sertraline was well tolerated and effective in children and adolescents with OCD or depression, with improvements in symptomatology (p < .001) 3.
• Another study published in 2025 found that sertraline was safe and effective in children and adolescents with OCD or depression, with a similar safety profile to that of adults 4.
• However, a study published in 2010 found that sertraline did not demonstrate efficacy in children and adolescents with PTSD compared to placebo 5.

Safety and Tolerability

• Sertraline has been found to be generally well tolerated in children and adolescents, with adverse events similar to those reported in adults 3, 4.
• Common adverse events reported in children and adolescents taking sertraline include psychiatric and gastrointestinal disorders 4.
• A study published in 2023 found that long-term sertraline use in children and adolescents was associated with normal development, with no significant changes in standardized height, cognitive function, or emotional development 6.

Comparison to Other Treatments

• A study published in 2004 compared the effectiveness of fluoxetine, cognitive-behavioral therapy (CBT), and their combination in adolescents with depression, and found that the combination of fluoxetine with CBT was superior to fluoxetine alone or CBT alone 7.
• However, it is worth noting that this study did not investigate sertraline specifically, but rather fluoxetine, another selective serotonin reuptake inhibitor (SSRI) 7.