What medications are FDA-approved to treat anxiety in children younger than 12?

FDA-Approved Medications for Anxiety in Children Under 12

Only sertraline is FDA-approved for anxiety disorders in children younger than 12 years old, specifically for obsessive-compulsive disorder (OCD) starting at age 6. 1

FDA-Approved Indications by Age

Sertraline (Ages 6-12)

• FDA-approved for OCD only in children ages 6-12 years 1
• Starting dose: 25 mg once daily for children ages 6-12 1
• Dose range: 25-200 mg/day, with adjustments made no more frequently than weekly 1
• Not FDA-approved for other anxiety disorders (generalized anxiety, separation anxiety, social anxiety, panic disorder) in this age group 1

Duloxetine (Ages 7 and Older)

• FDA-approved for generalized anxiety disorder starting at age 7 2
• This is the only SNRI with an FDA indication for any anxiety disorder in children 2

Critical Distinction: FDA Approval vs. Clinical Practice

While only sertraline (for OCD) and duloxetine (for GAD, age 7+) have FDA approval for anxiety in children under 12, the American Academy of Child and Adolescent Psychiatry guidelines support off-label use of SSRIs as a class for treating various anxiety disorders (social anxiety, generalized anxiety, separation anxiety, panic disorder) in children ages 6-18 years. 2

Evidence-Based Off-Label Options

• SSRIs as a class have considerable empirical support as safe and effective treatments for anxiety in children and adolescents 2
• Fluoxetine and escitalopram are reasonable alternatives if sertraline is not tolerated 3
• Avoid paroxetine and fluvoxamine due to higher discontinuation syndrome risk and potentially increased suicidal thinking 3

Optimal Treatment Approach

First-Line Recommendation

Cognitive-behavioral therapy (CBT) should be considered first-line treatment for mild to moderate anxiety, with SSRIs reserved for more severe presentations or when quality CBT is unavailable 2

Combination Therapy

• Combination treatment (CBT + SSRI) is more effective than either treatment alone for anxiety in children and adolescents 2, 3
• 12-20 structured CBT sessions targeting anxiety-specific cognitive distortions and exposure techniques are recommended 3

Safety Monitoring Requirements

Suicidal Ideation Risk

• All SSRIs carry a boxed warning for suicidal ideation through age 24 4
• Pooled absolute risk: 1% with SSRIs vs. 0.2% with placebo (number needed to harm = 143) 3, 4
• Close monitoring is mandatory in the first months of treatment and after dose changes 3, 4

Common Adverse Effects

• Nausea, headache, insomnia, nervousness, and initial anxiety/agitation typically resolve with continued treatment 3
• Parental oversight of medication regimens is paramount, including monitoring adherence and observing for adverse effects 4

Treatment Timeline Expectations

• Statistically significant improvement may begin by week 2 3
• Clinically significant improvement expected by week 6 3
• Maximal therapeutic benefit achieved by week 12 or later 3
• Do not abandon treatment before 12 weeks, as full response requires patience 3

Medications NOT FDA-Approved for Anxiety in Children Under 12

• Benzodiazepines: No FDA approval for anxiety disorders in children; may cause disinhibition in younger children 2, 5
• Buspirone: Randomized controlled trials do not suggest efficacy in pediatric anxiety 5
• Tricyclic antidepressants: Questionable efficacy and significant safety concerns (cardiotoxicity, lethality in overdose) 6, 7