FDA-Approved Medications for Generalized Anxiety Disorder in Children Ages 7-17
Duloxetine is the only medication with FDA approval specifically for treating generalized anxiety disorder in children and adolescents aged 7 years and older. 1
Primary FDA-Approved Option
Duloxetine (Cymbalta) is FDA-indicated for GAD in pediatric patients aged 7-17 years, with dosing of 30-120 mg daily. 2, 1
- The FDA approval is based on a 10-week randomized controlled trial (n=272 pediatric patients, 47% aged 7-11 years) demonstrating superiority over placebo on the Pediatric Anxiety Rating Scale (PARS) for GAD severity score. 1, 3
- Mean improvement from baseline was significantly greater for duloxetine (-9.7) compared with placebo (-7.1, p ≤ .001, Cohen's d: 0.5). 3
- Response rates (50% improvement on PARS) were 59% for duloxetine versus 42% for placebo, and remission rates (PARS ≤8) were 50% versus 34%, respectively (p ≤ .05). 3
Dosing Strategy for Duloxetine
Start duloxetine at 30 mg daily and titrate flexibly to 30-120 mg daily based on response and tolerability. 1, 3
- Single daily dosing is appropriate due to duloxetine's sufficiently long elimination half-life. 2
- Allow adequate time for response assessment, as maximal therapeutic benefit may not be achieved until week 12 or later. 4
Safety Monitoring for Duloxetine
Monitor closely for suicidal thinking and behavior, especially during the first months of treatment and after dose changes. 1
- Common adverse events include gastrointestinal symptoms (nausea), oropharyngeal pain, dizziness, cough, and palpitations. 3
- Mean pulse increase of +6.5 beats/min and mean weight change of -0.1 kg were observed versus placebo (+2.0 beats/min, +1.1 kg). 3
- Regular monitoring of weight and growth is required in pediatric patients. 1
- Discontinuation rates due to adverse events did not differ significantly from placebo. 3
Off-Label Alternatives with Strong Evidence
While not FDA-approved for pediatric GAD, SSRIs have high-quality evidence supporting their use and are recommended by the American Academy of Child and Adolescent Psychiatry for patients aged 6-18 years with GAD. 2
Escitalopram (Off-Label)
- Dosing: 10-20 mg daily for ages 7-17 years. 4, 5
- An 8-week randomized controlled trial (n=275) demonstrated superiority over placebo on PARS severity for GAD (least squares mean difference = -1.42; p = 0.028). 6
- Well tolerated with safety data extending to children aged 7-11 years. 6
Sertraline (Off-Label)
- Dosing: Start 25 mg daily for week 1, increase to 50 mg daily, with target therapeutic dose of 50-200 mg/day. 4
- Statistically significant improvement may begin by week 2, with clinically significant improvement by week 6. 4, 5
- Pooled risk of suicidal thinking is 1% versus 0.2% placebo (NNH = 143). 4
Critical Implementation Considerations
Combination treatment with cognitive behavioral therapy (CBT) plus medication provides superior outcomes to either treatment alone. 2, 4, 5
- A structured course of 12-20 CBT sessions targeting anxiety-specific cognitive distortions and exposure techniques is recommended. 4, 5
- Individual CBT is prioritized over group therapy due to superior clinical and cost-effectiveness. 5
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. 4
- In younger children, benzodiazepines may cause disinhibition. 2
- One study found 63% of trauma patients on benzodiazepines developed PTSD versus only 23% on placebo. 4
Treatment Duration
Continue medication for at least 9-12 months after achieving remission to prevent relapse. 4, 5