What medications are currently FDA (Food and Drug Administration) approved to treat anxiety disorders in children and adolescents?

FDA-Approved Medications for Anxiety in Children and Adolescents

Only two medications have FDA approval for anxiety disorders in pediatric patients: fluoxetine for OCD in children aged 7 and older, and fluvoxamine for OCD in children aged 8 and older. 1, 2

FDA-Approved Indications by Specific Disorder and Age

Obsessive-Compulsive Disorder (OCD)

• Fluoxetine (Prozac): FDA-approved for OCD in children and adolescents, with efficacy established in a 13-week trial 1
• Fluvoxamine: FDA-approved for OCD in pediatric patients aged 8-17 years, with efficacy demonstrated in a 10-week multicenter placebo-controlled study of 120 outpatients 2

Other Anxiety Disorders

• No FDA-approved medications exist for generalized anxiety disorder, social anxiety disorder, panic disorder, separation anxiety disorder, or specific phobias in children and adolescents under age 18 3
• Duloxetine has FDA approval for generalized anxiety disorder starting at age 7, though this represents the only non-OCD anxiety indication for pediatric patients 3

Critical Distinction: FDA Approval vs. Evidence-Based Practice

Despite limited FDA approvals, SSRIs as a class have substantial empirical support for treating various anxiety disorders in children ages 6-18 years and are recommended as first-line pharmacotherapy by the American Academy of Child and Adolescent Psychiatry. 3, 4, 5

Off-Label SSRI Use with Strong Evidence

• Sertraline, escitalopram, and fluoxetine are supported as first-line agents for anxiety disorders beyond OCD, despite lacking specific FDA approval for these indications in pediatric populations 6, 7
• Fluvoxamine demonstrated efficacy not only for OCD but also for social phobia, separation anxiety disorder, and generalized anxiety disorder in an 8-week controlled trial of 128 pediatric patients (up to 250-300 mg/day) 8

Dosing Specifications for FDA-Approved Medications

Fluoxetine for Pediatric OCD

• Adolescents and higher-weight children: Start 10 mg/day, increase to 20 mg/day after 2 weeks, with a target range of 20-60 mg/day 1
• Lower-weight children: Start 10 mg/day, with a target range of 20-30 mg/day 1
• Maximum dose should not exceed 60 mg/day in pediatric patients (80 mg/day in adults) 1

Fluvoxamine for Pediatric OCD

• Children aged 8-11 years: Steady-state plasma concentrations are 2-3 times higher than in adolescents, requiring a maximum dose of 200 mg/day 2, 8
• Adolescents aged 12-17 years: Absorption similar to adults, allowing maximum doses up to 300 mg/day 2, 8
• Dosing range in controlled trials: 50-300 mg/day over 8-16 weeks 8

Optimal Treatment Algorithm

First-Line Approach

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. 3

When Medication is Indicated

• Combination treatment (CBT + SSRI) is more effective than either treatment alone for anxiety in children and adolescents, with superior outcomes demonstrated in the Child-Adolescent Anxiety Multimodal Study 3, 6
• A structured course of 12-20 CBT sessions targeting anxiety-specific cognitive distortions and exposure techniques is recommended 6

Mandatory Safety Monitoring

Suicidal Ideation Risk

• All SSRIs carry a black box warning for suicidal ideation through age 24, with a pooled absolute risk of 1% with SSRIs versus 0.2% with placebo (NNH = 143) 3, 6
• Close monitoring is mandatory in the first months of treatment and after any dose changes 3, 6

Common Side Effects

• Nausea, headache, insomnia, nervousness, and initial anxiety/agitation typically emerge within the first few weeks and resolve with continued treatment 6, 7
• Decreased appetite and weight loss require regular monitoring of weight and growth if long-term SSRI treatment continues 2

Medications to Avoid

Benzodiazepines

Benzodiazepines are not FDA-approved for anxiety disorders in children and may cause disinhibition in younger children. 3

• The American Academy of Child and Adolescent Psychiatry does not recommend benzodiazepines for chronic anxiety management in adolescents due to concerns about dependence and potential worsening of long-term outcomes 6

Paroxetine and Specific SSRIs

• Paroxetine and fluvoxamine should be avoided as first-line agents due to higher discontinuation syndrome risk and potentially increased suicidal thinking compared to other SSRIs 6

Expected Response Timeline

• Statistically significant improvement may begin by week 2 6, 7
• Clinically significant improvement expected by week 6 6, 7
• Maximal therapeutic benefit achieved by week 12 or later 6, 7
• Treatment should not be abandoned before 12 weeks, as full response requires patience due to the logarithmic response curve of SSRIs 6

Treatment Duration

Continuing SSRI therapy for at least 9-12 months after achieving remission is recommended to prevent relapse. 6