Drug updated on 4/17/2024
| Dosage Form | Solution (oral; 100 mg/mL) |
| Drug Class | Cannabinoids |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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
- 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.
- A total of 12 systematic reviews/meta-analyses were reviewed to gather information about this drug's safety and effectiveness.
- The use of cannabidiol (Epidiolex) has been linked to an increased probability of liver enzyme elevation and drug-induced liver injury compared to placebo controls, particularly at high doses and when used concurrently with other antiepileptic drugs.
- While effective in reducing seizure frequency in conditions like Lennox-Gastaut syndrome (LGS), Dravet Syndrome (DS), and pediatric epilepsy, cannabidiol's use is also associated with adverse events such as gastrointestinal symptoms which raises concerns regarding its overall tolerability.
- Compared to other antiseizure medications like stiripentol, fenfluramine, soticlestat; cannabidiol appears slightly less safe due to a higher risk profile especially at higher doses making it necessary for cautious dosing escalation among adult users below 300 mg/day dosage level where no severe DILI cases were reported.
- In children suffering from epilepsy who are treated using Epidiolex(cannabidinoid), there was a significant reduction in seizure frequency but potential mental health impacts along with decreased appetite have raised concerns regarding its usage within this population group.
- When treating LGS using combination therapy involving high-dose clobazam,rufinamide alongside CBD showed significant efficacy however the presence of treatment-emergent adverse events presents a caveat necessitating careful management during concurrent therapies involving anti-epileptic drugs so as not exacerbate potential liver safety risks.
- CBD shows no significant effect on health-related quality life (HRQoL) or mental well-being in oncological and central nervous system (CNS) disease patients, suggesting its limited utility in improving these specific areas despite its use.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Epidiolex (cannabidiol) Prescribing Information. | 2022 | Greenwich Biosciences, Inc., Carlsbad, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Adapted Evidence-Based Clinical Practice Guidelines for Diagnosis and Treatment of Epilepsies in Children: A Tertiary Children's Hospital Update. | 2023 | Pediatric Neurology |
| Guideline No. 425b: Cannabis Use Throughout Women's Lifespans - Part 2: Pregnancy, the Postnatal Period, and Breastfeeding. | 2022 | Journal of Obstetrics and Gynaecology Canada |
| Medical cannabis or cannabinoids for chronic pain: a clinical practice guideline. | 2021 | BMJ |
| Medical cannabis in the UK: From principle to practice. | 2020 | Journal of Psychopharmacology |
| Epilepsy and cannabidiol: a guide to treatment. | 2020 | Epileptic Disorders |