Cannabidiol

(Epidiolex®)

Epidiolex®

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Drug updated on 5/17/2024

Dosage FormSolution (oral; 100 mg/mL)
Drug ClassCannabinoids
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or Tuberous sclerosis complex in patients 1 year of age and older.

Summary
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  • Cannabidiol (Epidiolex) is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or Tuberous sclerosis complex in patients 1 year of age and older.
  • Twenty studies were reviewed to gather information about this drug.
  • Compared to other drugs such as stiripentol and fenfluramine used for treating Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), cannabidiol shows promising outcomes in reducing seizure frequency but may be less effective than these alternatives.
  • In pediatric patients with DS, cannabidiol has an acceptable safety profile and offers a significant reduction in seizure frequency, showing substantial efficacy in a subgroup of patients.
  • For adult and adolescent patients using cannabidiol as adjunct therapy in focal epilepsy, LGS, or TSC, it showed good efficacy, which varied among different epilepsy subtypes and age groups.
  • The safety profile of cannabidiol was generally favorable across studies, with manageable adverse events, including somnolence, decreased appetite, diarrhea, and elevated liver enzymes; however, there was an elevated risk for discontinuation due to adverse reactions when compared to other treatments like stiripentol or fenfluramine.
  • Studies emphasize that while cannabidiol is a valuable addition to current therapeutic options for refractory epilepsy syndromes, notably DS and LGS, it might be less effective than some newer drugs like fenfluramine regarding seizure reduction or achieving seizure freedom.
  • The potential positive impact of cannabidiol on mental well-being and quality of life remains inconclusive, suggesting a need for further research despite its consistent efficacy across various age groups, including children and adults suffering from DS, LGS, TSC.

Product Monograph / Prescribing Information

Document TitleYearSource
Epidiolex (cannabidiol) Prescribing Information.2024Greenwich Biosciences, Inc., Carlsbad, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The efficacy and safety of cannabidiol (CBD) in pediatric patients with Dravet Syndrome: a narrative review of clinical trials.2024European Journal of Medical Research
Comparative efficacy and safety of stiripentol, cannabidiol and fenfluramine as first-line add-on therapies for seizures in Dravet syndrome: a network meta-analysis.2024Epilepsia Open
Efficacy of pharmacological treatments for Dravet syndrome: Systematic review and network meta-analysis.2024Seizure
Efficacy and safety of six new antiseizure medications for adjunctive treatment of focal epilepsy and epileptic syndrome: a systematic review and network meta-analysis.2024Epilepsy & Behavior
Cannabidiol-associated hepatotoxicity: a systematic review and meta-analysis.2023Journal of Internal Medicine
Adverse events of cannabidiol use in patients with epilepsy a systematic review and meta-analysis.2023Jama Network
Cannabinoids to improve health-related quality of life in patients with neurological or oncological disease: a meta-analysis.2023Cannabis and Cannabinoid Research
Pharmacotherapy for Dravet Syndrome: a systematic review and network meta-analysis of randomized controlled trials.2023Drugs
The use of cannabinoids in children with epilepsy: a systematic review.2023Epilepsy & Behavior
Efficacy and safety of adjunctive antiseizure medications for Dravet syndrome: a systematic review and network meta-analysis.2022Frontiers in Pharmacology
Short-term and long-term efficacy and safety of antiseizure medications in Lennox Gastaut syndrome: a network meta-analysis.2022Seizure: European Journal of Epilepsy
Clinical efficacy and safety of cannabidiol for pediatric refractory epilepsy indications: a systematic review and meta-analysis.2022Experimental Neurology
Anti-seizure medications for Lennox-Gastaut syndrome. 2021The Cochrane Database of Systematic Reviews
Highly purifed cannabidiol for epilepsy treatment: a systematic review of epileptic conditions beyond Dravet syndrome and Lennox–Gastaut syndrome. 2021CNS Drugs
Efficacy and safety of medical cannabinoids in children: a systematic review and meta-analysis.2021Scientific Reports
Adjunctive cannabidiol in patients with Dravet syndrome: a systematic review and meta-analysis of efficacy and safety.2020CNS Drugs
Cannabis-based products for pediatric epilepsy: an updated systematic review. 2020Seizure
Cannabis-based products for pediatric epilepsy: a systematic review.2019Epilepsia
Efficacy and safety of cannabidiol in epilepsy: a systematic review and meta‑analysis.2018Drugs
Efficacy and safety of adjunctive cannabidiol in patients with Lennox-Gastaut syndrome: a systematic review and meta-analysis.2018CNS Drugs

Clinical Practice Guidelines