Buspirone is NOT FDA Indicated for Use in Children
Buspirone is not FDA approved for use in children of any age group. According to the FDA drug label, the safety and effectiveness of buspirone were evaluated in two placebo-controlled 6-week trials involving 559 pediatric patients (ages 6-17) with Generalized Anxiety Disorder (GAD), but there were no significant differences between buspirone and placebo regarding GAD symptoms 1.
Evidence from FDA Labeling
The FDA label for buspirone clearly states:
- Clinical trials in pediatric patients (ages 6-17) with GAD showed no significant differences between buspirone and placebo for treating anxiety symptoms 1
- No long-term safety or efficacy data exists for buspirone use in pediatric populations 1
- Pharmacokinetic studies have shown that plasma exposure to buspirone and its active metabolite (1-PP) are equal to or higher in pediatric patients than adults for identical doses 1
Research on Buspirone in Children
Despite not being FDA approved for pediatric use, some research has investigated buspirone in children:
- Buspirone has been studied in children with autism spectrum disorder, with one pharmacokinetic study showing that it is rapidly absorbed and eliminated in young children with extensive metabolism to its active metabolite 1-PP 2
- A Bayesian analysis of abandoned randomized controlled trials found that buspirone was well-tolerated in pediatric patients with GAD, but the studies were underpowered to detect small effect sizes 3
- A retrospective chart review suggested potential benefits of buspirone for anxiety in youth with high-functioning autism spectrum disorder, but this requires further investigation with prospective and randomized controlled trials 4
Comparison to Other Pediatric Anxiety Treatments
Unlike buspirone, some medications do have FDA approval for pediatric anxiety or related conditions:
- For ADHD, the American Academy of Pediatrics recommends FDA-approved medications for children 6-11 years and adolescents 12-18 years 5
- For children under 12, medications like budesonide nebulizer suspension (for ages 1-8) and montelukast (for ages 1-5) have received FDA approval for conditions like asthma 5
Important Considerations
- The lack of FDA approval doesn't necessarily mean buspirone is unsafe for children, but rather that sufficient evidence for efficacy hasn't been established
- Pharmacokinetic differences between children and adults have been observed, with children potentially having higher plasma concentrations of buspirone and its metabolites 2
- A review of anxiolytic medications noted that controlled studies supporting the efficacy of buspirone for psychiatric disorders in children and adolescents are virtually non-existent 6
Clinical Implications
When considering medication for anxiety in children:
- FDA-approved medications should be considered first-line options
- If buspirone is considered for off-label use, clinicians should be aware of the limited evidence base
- Careful monitoring is essential, particularly given the observed pharmacokinetic differences between children and adults
- Informed consent discussions with parents/guardians should clearly communicate the medication's off-label status and the limited evidence supporting its use
In conclusion, while buspirone has been studied in pediatric populations and some research suggests potential benefits for specific conditions like anxiety in autism spectrum disorder, it does not have FDA approval for use in children, and the evidence supporting its efficacy in pediatric anxiety disorders remains limited.