Skip to main content
Pharmacokinetics of cannabidiol in children with refractory epileptic encephalopathy
  • Paulo Cáceres Guido
  • Natalia Riva
  • Roberto Caraballo
  • Gabriela Reyes
  • Marina Huaman
  • Robinson Gutierrez
  • Silvana Agostini
  • Sandra Fabiana Delaven
  • Carlos A Pérez Montilla
  • Facundo Garcia-Bournissen, MD PhD
  • Paula Schaiquevich
Document Type
Publication Date
URL with Digital Object Identifier

Growing interest in the clinical use of cannabidiol (CBD) as adjuvant therapy for pediatric refractory epileptic encephalopathy emphasizes the need for drug treatment optimization. The aim of this study was to characterize the pharmacokinetics of CBD in pediatric patients with refractory epileptic encephalopathy receiving an oil-based oral solution. To evaluate CBD concentrations, six serial blood samples per patient were collected after the morning dose of CBD, at least 21 days after the beginning of treatment. Twelve patients who received a median (range) dose of 12.2 (5.3-19.4) mg/kg/d (twice daily) were included in the analysis. Median (range) CBD time to maximum plasma concentration, maximum plasma concentration, and area under the concentration versus time curve up to 6 hours after dosing were 3.2 hours (1.9-6.2), 49.6 ng/mL (14.4-302.0), and 226.3 ng ⋅ h/mL (70.5-861.3), respectively. CBD systemic exposure parameters were in the lower range of previous reports in pediatric patients receiving doses in a similar range. Most of our patients (83%) showed little CBD plasma level fluctuation during a dosing interval, comparable to that encountered after oral administration of an extended release drug delivery system. CDB administration was generally safe and well tolerated, and a novel levothyroxine-CBD interaction was recorded. Similar to other studies, large interindividual variability in CBD exposure was observed, encouraging the use of CBD therapeutic drug monitoring.

Citation Information
Paulo Cáceres Guido, Natalia Riva, Roberto Caraballo, Gabriela Reyes, et al.. "Pharmacokinetics of cannabidiol in children with refractory epileptic encephalopathy" Epilepsia Vol. 62 Iss. 1 (2021) p. e7 - e12
Available at: