Cannabidiol

(Epidiolex®)

Epidiolex®

Drug updated on 10/29/2024

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.

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Summary
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  • This summary is based on the review of 21 systematic review(s)/meta-analysis(es). [1-21]
  • Seizure Reduction in Dravet Syndrome (DS): Cannabidiol (CBD) reduced seizure frequency by 33%, with a 20% increase in the number of patients achieving a ≥50% reduction in seizures and a 3% increase in seizure freedom. However, CBD was less effective than stiripentol, fenfluramine, and soticlestat in reducing seizure frequency by ≥50%.
  • Seizure Reduction in Lennox-Gastaut Syndrome (LGS): High-dose CBD significantly reduced drop seizure frequency in patients with LGS and drug-resistant epilepsy, showing a ≥50% reduction in seizure frequency compared to placebo. CBD was effective in LGS both with and without concomitant clobazam (CLB).
  • Seizure Reduction in Other Conditions: CBD demonstrated effectiveness in reducing seizures in patients with tuberous sclerosis complex (TSC) and pediatric epilepsy. It also showed therapeutic benefits for epilepsy and Parkinsonism.
  • Comparative Effectiveness: Stiripentol, fenfluramine, and soticlestat were more effective than CBD in reducing convulsive seizures in DS, with higher seizure response rates and a greater probability of achieving a ≥50% reduction in seizure frequency.
  • Cannabidiol (CBD) was associated with an increase in adverse events (AEs) by 12%, serious AEs by 16%, and a 15% increase in transaminase elevations, particularly in patients using concomitant valproate. Common AEs included somnolence and sedation, especially when used with clobazam (CLB).
  • CBD had a lower proportion of participants experiencing AEs compared to fenfluramine, but a higher risk of AEs than stiripentol. High-dose CBD had significantly higher odds of treatment-emergent adverse events (TEAEs) compared to placebo.
  • Adverse events specific to CBD use included decreased appetite, rash, pneumonia, and aggression, with higher incidences of somnolence and sedation reported in patients taking CBD with CLB.
  • Cannabidiol (CBD) has demonstrated effectiveness in reducing seizures in pediatric patients with Dravet Syndrome (DS), children and adults with Lennox-Gastaut Syndrome (LGS), and patients with tuberous sclerosis complex (TSC) and drug-resistant epilepsy. In subgroups, CBD's efficacy was observed both with and without concomitant clobazam (CLB), with notable differences in safety profiles when used alongside CLB, particularly higher rates of somnolence and sedation.

Product Monograph / Prescribing Information

Document TitleYearSource
Epidiolex (cannabidiol) Prescribing Information.2024Jazz Pharmaceuticals, Inc., Palo Alto, 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 trials2024European 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-analysis2024Epilepsia Open
Pharmacotherapy for Dravet Syndrome: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2023Drugs
Clinical efficacy and safety of cannabidiol for pediatric refractory epilepsy indications: a systematic review and meta-analysis.2023Experimental Neurology
Adverse events of cannabidiol use in patients with epilepsy a systematic review and meta-analysis.2023JAMA Network Open
Use of cannabidiol in the treatment of epilepsy: Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex2022Revista da Associacao Medica Brasileira (1992)
Efficacy and safety of adjunctive antiseizure medications for dravet syndrome: A systematic review and network meta-analysis2022Frontiers in Pharmacology
Medical cannabinoids: a pharmacology-based systematic review and meta-analysis for all relevant medical indications2022BMC Medicine
Cannabis and cannabinoids for symptomatic treatment for people with multiple sclerosis2022The Cochrane Database of Systematic Reviews
Short-term and long-term efficacy and safety of antiseizure medications in Lennox Gastaut syndrome: A network meta-analysis2022Seizure
Neurological Benefits, Clinical Challenges, and Neuropathologic Promise of Medical Marijuana: A Systematic Review of Cannabinoid Effects in Multiple Sclerosis and Experimental Models of Demyelination2022Biomedicines
Efficacy and safety of antiseizure medication for Lennox-Gastaut syndrome: a systematic review and network meta-analysis2022Developmental Medicine and Child Neurology
Efficacy and safety of medical cannabinoids in children: a systematic review and meta-analysis2021Scientific Reports
Anti-seizure medications for Lennox-Gastaut syndrome2021The Cochrane Database of Systematic Reviews
Highly Purified Cannabidiol for Epilepsy Treatment: A Systematic Review of Epileptic Conditions Beyond Dravet Syndrome and Lennox-Gastaut Syndrome2021CNS Drugs
Immunomodulatory Potential of Cannabidiol in Multiple Sclerosis: a Systematic Review2021Journal of Neuroimmune Pharmacology
Cannabidiol in conjunction with clobazam: analysis of four randomized controlled trials2021Acta Neurologica Scandinavica
Cannabidiol efficacy independent of clobazam: Meta-analysis of four randomized controlled trials2020Acta Neurologica Scandinavica
Cannabidiol efficacy and clobazam status: A systematic review and meta-analysis2020Epilepsia
Adjunctive Cannabidiol in Patients with Dravet Syndrome: A Systematic Review and Meta-Analysis of Efficacy and Safety2020CNS Drugs
Cannabis-based products for pediatric epilepsy: An updated systematic review2020Seizure

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