Which medications are FDA‑approved for treating an anxiety disorder in a 9‑year‑old child?

FDA-Approved Medications for Anxiety in 9-Year-Old Children

Duloxetine (Cymbalta) is the only FDA-approved medication for generalized anxiety disorder in children aged 7–17 years, with dosing starting at 30 mg daily and titrating flexibly to 30–120 mg daily based on response and tolerability. 1

FDA-Approved Options by Specific Anxiety Disorder

Generalized Anxiety Disorder (GAD)

• Duloxetine is FDA-approved for pediatric GAD in patients aged 7–17 years, demonstrated in a 10-week randomized controlled trial showing superiority over placebo on the Pediatric Anxiety Rating Scale (PARS) for GAD severity. 1
• Single daily dosing of duloxetine is appropriate due to its sufficiently long elimination half-life, starting at 30 mg daily and titrating to 30–120 mg daily. 1
• Common early side effects include nausea, which can be reduced by starting at 30 mg daily for one week before increasing. 2

Obsessive-Compulsive Disorder (OCD)

• Fluoxetine is FDA-approved for major depression in children/adolescents aged 8 years or older and has demonstrated efficacy for OCD in pediatric populations, though the specific OCD indication applies to ages 7 and up. 3
• Fluvoxamine (50–300 mg/day) for 8–16 weeks significantly reduced OCD symptoms compared with placebo in controlled trials of 120 pediatric patients, with improvements observed for up to 1 year. 4
• The maximum fluvoxamine dosage recommended for children aged 6–11 years is 200 mg/day (versus 300 mg/day for adolescents 12–17 years) due to 2–3 times higher steady-state plasma concentrations in younger children. 4

Other Anxiety Disorders (Social Phobia, Separation Anxiety)

• Fluvoxamine (up to 250–300 mg/day) improved anxiety symptoms compared with placebo in an 8-week controlled trial of 128 pediatric patients with social phobia, separation anxiety disorder, or GAD. 4

Off-Label SSRIs with Strong Pediatric Evidence

While not FDA-approved for pediatric anxiety disorders specifically, the following have robust evidence:

• Escitalopram (10–20 mg daily) and sertraline (50–200 mg daily) are recommended by the American Academy of Child and Adolescent Psychiatry for patients aged 6–18 years with GAD, social anxiety, separation anxiety, and panic disorders, despite lacking FDA approval for pediatric GAD. 1
• Escitalopram reduced anxiety symptoms and was well tolerated in a multicenter trial of children aged 7–17 years with GAD, showing superiority to placebo on PARS severity scores (least squares mean difference = -1.42; p = 0.028). 5
• For a 9-year-old, escitalopram should be started at 5–10 mg daily and increased by 5–10 mg increments every 1–2 weeks, targeting 10–20 mg daily by weeks 4–6. 1

Critical Implementation Considerations

Timeline for Response

• Statistically significant improvement may begin by week 2, with clinically meaningful improvement expected by week 6, and maximal therapeutic benefit achieved by week 12 or later. 1
• Treatment should not be abandoned before 12 weeks, as full response requires patience due to the logarithmic response curve of SSRIs. 1

Mandatory Monitoring

• All SSRIs and SNRIs carry a boxed warning for suicidal thinking and behavior in individuals up to age 24, with pooled absolute rates of 1% versus 0.2% for placebo (number needed to harm = 143). 1
• Monitor closely for suicidal thoughts, especially in the first months and after dose changes. 1

Combination with Psychotherapy

• Combining medication with cognitive behavioral therapy (CBT) provides superior outcomes to either treatment alone for pediatric anxiety disorders, with individual CBT preferred over group therapy. 1
• A structured course of 12–20 CBT sessions targeting anxiety-specific cognitive distortions and exposure techniques is recommended. 1

Medications to Avoid

• Benzodiazepines should not be used for chronic anxiety management in pediatric patients due to concerns about disinhibition, dependence, and potential worsening of long-term outcomes. 1
• 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. 1
• Tricyclic antidepressants should be avoided due to unfavorable risk-benefit profile, particularly cardiac toxicity. 2

Dosing Strategy Pitfalls to Avoid

• Do not escalate doses too quickly—allow 1–2 weeks between increases to assess tolerability and avoid overshooting the therapeutic window. 1
• Do not discontinue abruptly—taper gradually to avoid withdrawal symptoms, particularly with shorter half-life SSRIs. 1
• Dosing in pediatric patients must be adjusted for age and weight, employing slower titration compared with adult regimens. 1