Since our initial 2019 coverage of CBD for children, significant advances in research have provided clearer insights into both the potential benefits and risks of cannabidiol (CBD) use in pediatric populations. While promising developments have emerged, particularly around autism spectrum disorder and epilepsy, the landscape remains complex and requires careful medical supervision.
The Evolution of CBD Research in Children (2019-2025)
The past six years have witnessed remarkable progress in pediatric CBD research. Most notably, Epidiolex - the first and only FDA-approved CBD medication - has expanded its approved indications beyond the initial Dravet syndrome and Lennox-Gastaut syndrome to include tuberous sclerosis complex (TSC) in patients 1 year of age and older. This expansion came after rigorous clinical trials demonstrated significant seizure reduction in children with TSC.
According to the FDA's 2020 approval announcement, Epidiolex represents the gold standard for pharmaceutical-grade CBD, with consistent dosing and proven safety profiles established through extensive clinical trials.
Current FDA-Approved Uses for Children
Epidiolex remains the only CBD product approved by the FDA for pediatric use, specifically for treating seizures associated with:
- Lennox-Gastaut syndrome (LGS)
- Dravet syndrome
- Tuberous sclerosis complex (TSC)
All approvals are for patients 1 year of age and older. Clinical studies have shown that Epidiolex significantly reduces seizure frequency in these rare, severe forms of epilepsy where traditional medications often fail.
Emerging Research: Autism Spectrum Disorder
Perhaps the most exciting development in pediatric CBD research has been the growing evidence for its potential benefits in autism spectrum disorder (ASD). Multiple clinical trials conducted between 2020-2025 have shown promising results:
Key Clinical Trial Findings
A 2025 meta-analysis presented at the European Congress of Psychiatry analyzed three randomized, placebo-controlled trials involving 276 participants with autism. The results demonstrated:
- Moderate improvements in social responsiveness
- Small but notable reductions in disruptive behaviors
- Decreased anxiety symptoms
- Safety profile comparable to placebo
A significant 2024 Brazilian study involving 60 children aged 5-11 with autism found that CBD-rich cannabis extract improved social interaction - one of the core diagnostic criteria for ASD - while causing few serious adverse effects.
Similarly, research from the University of California San Diego found that approximately two-thirds of autistic boys with severe behavioral problems showed improvements with CBD treatment, though researchers noted the importance of placebo effects and the need for larger studies.
Safety Profile: What Current Research Shows
Recent comprehensive safety assessments have provided clearer guidance on CBD's safety profile in children:
Well-Documented Side Effects
Based on clinical trials and FDA data, the most common side effects in children include:
- Gastrointestinal issues: Diarrhea, decreased appetite, vomiting
- Neurological effects: Drowsiness, sedation, fatigue
- Behavioral changes: Irritability, mood changes
- Physical symptoms: Fever, ataxia (loss of coordination)
Serious Safety Considerations
Liver toxicity remains the most serious concern. Clinical trials have shown that some children, particularly those taking valproic acid concurrently, developed elevated liver enzymes. Regular monitoring is essential.
Drug interactions are significant, particularly with common seizure medications like clobazam, where CBD can increase blood levels of the active metabolite.
The Problem with Over-the-Counter CBD Products
One of the most important developments since 2019 has been increased awareness of the quality and safety issues with non-prescription CBD products. Recent analyses have shown that many commercially available CBD products:
- Contain inaccurate labeling - often having more or less CBD than advertised
- May contain detectable THC levels that could cause intoxication in children
- Lack quality control and independent verification
- Are not regulated by the FDA for safety or efficacy
As pediatric neurologists warn, "There is only one FDA-approved drug derived from a pure form of CBD oil, Epidiolex, which has proven effective in reducing seizures in some severe types of epilepsy. Other than that, there have been no well-designed, randomized controlled trials to tell us if CBD is safe and effective for other conditions."
Current Medical Consensus and Guidelines
What Medical Organizations Say
The American Academy of Pediatrics maintains its position that they "do not support any use of medical marijuana products that haven't been approved by the FDA."
Leading pediatric hospitals, including Akron Children's Hospital, emphasize that "CBD can cause sleepiness or even sedation, mood changes, decreased appetite, vomiting and diarrhea. It also has been associated with liver toxicity and seizures."
When CBD Might Be Considered
Based on current evidence, CBD may be considered for children in specific circumstances:
- FDA-approved conditions: Epilepsy syndromes where Epidiolex has proven efficacy
- Research settings: Clinical trials for autism and other conditions
- Compassionate use: Severe, treatment-resistant cases under strict medical supervision
Conditions Under Investigation
Autism Spectrum Disorder
Current clinical trials, including ongoing research at NYU Langone, are investigating CBD for children with co-occurring autism and ADHD. Early results suggest potential benefits for social difficulties, anxiety, and sleep problems.
ADHD: Limited Evidence
Despite anecdotal reports, research on CBD for ADHD remains extremely limited. A small 2017 study of 30 adults showed inconclusive results, and no pediatric studies have demonstrated efficacy for ADHD symptoms.
Anxiety and Sleep Disorders
While some case reports suggest benefits for pediatric anxiety and sleep issues, these remain under investigation with insufficient evidence for routine clinical use.
Calculating Dosage for Children
When CBD is medically appropriate, dosing must be carefully calculated and monitored:
FDA-Approved Dosing Guidelines
For Epidiolex in approved conditions:
- Starting dose: 2.5 mg/kg twice daily
- Maintenance dose: 5 mg/kg twice daily after one week
- Maximum dose: Up to 10 mg/kg twice daily if needed and tolerated
Research Dosing
Clinical trials for autism have typically used:
- Starting dose: 1-5 mg/kg daily
- Typical range: 5-10 mg/kg daily
- Maximum studied: Up to 20 mg/kg daily in some trials
Important: These dosing guidelines should never be used without medical supervision, as individual responses vary significantly.
Working with Healthcare Providers
If considering CBD for your child, experts recommend:
- Consult your pediatrician first - Even if they don't recommend CBD, they need to know what supplements your child is taking
- Seek specialists when appropriate - Pediatric neurologists or developmental pediatricians for specific conditions
- Consider clinical trials - These provide access to pharmaceutical-grade products with safety monitoring
- Monitor for interactions - CBD can affect how other medications work
- Regular follow-up - Including liver function tests when indicated
The Future of Pediatric CBD Research
The landscape for pediatric CBD research continues to evolve rapidly. Current priorities include:
- Larger randomized controlled trials for autism spectrum disorder
- Long-term safety studies to understand chronic use effects
- Optimal dosing research for different conditions and age groups
- Biomarker development to predict which children will respond
Several major clinical trials are ongoing, including studies at UC San Diego and other leading medical centers, which should provide more definitive answers in the coming years.
Key Takeaways for Parents
- CBD is not a cure-all - It has specific, proven uses and significant limitations
- Only FDA-approved Epidiolex has established safety and efficacy for children
- Commercial CBD products pose risks due to quality control issues
- Medical supervision is essential - Never start CBD without healthcare provider involvement
- Promising research exists for autism, but more studies are needed
- Consider clinical trials for access to quality products and monitoring
Conclusion
The past six years have brought significant advances in our understanding of CBD's potential for children, particularly in autism spectrum disorder and rare epilepsy syndromes. While the research is increasingly promising, the medical consensus remains clear: CBD should only be used in children under proper medical supervision, preferably with FDA-approved products or within clinical trial settings.
For parents considering CBD for their children, the most important step is having an open, honest conversation with qualified healthcare providers who can assess the specific risks and benefits for each individual child.
Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare providers before considering any CBD products for children. The information presented here reflects current research as of 2025 and may change as new studies emerge.
