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Cannabidiol Oral Solution (Epidiolex)

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Drs. Elliott and Chan report no financial relationships relevant to this field of study.

The FDA has approved a purified drug substance derived from marijuana for the treatment of two rare but severe forms of epilepsy in children. Cannabidiol (CBD) is a cannabinoid that does not share the psychoactive properties of tetrahydrocannabinol (THC). The product was granted priority review and received fast-track and orphan designations. It is marketed as an oral solution called Epidiolex.


Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients ≥ 2 years of age. 1


The recommended starting dose is 2.5 mg/kg taken orally twice daily. 1 After one week, the dose can increase to 5 mg/kg twice daily. Based on response and tolerability, the dose may rise to a maximum of 10 mg/kg twice daily. Serum transaminases (ALT and AST) and total bilirubin levels should be determined prior to treatment initiation. Dosage adjustment is recommended in patients with moderate or severe hepatic impairment. A dose reduction should be considered with concomitant administration of a moderate or strong CYP3A4 or CYP2C19 inhibitor. A dose increase may be required with strong inducers of these isoenzymes. Epidiolex is available as an oral solution 100 mg/mL.


The addition of CBD to conventional antiepileptics results in a significant reduction in the number of seizures in treatment-resistant patients with Lennox-Gastaut syndrome or Dravet syndrome. 1-4


CBD is associated with dose-related elevation of serum transaminases (three times the upper limit of normal), somnolence/sedation, and weight loss (≥ 5%). 1 Other adverse reactions include decreased appetite, diarrhea, fatigue/malaise/asthenia, rash, and anemia. As with other antiepileptics, CBD may increase the risk of suicidal behavior and ideation.


The safety and efficacy of CBD were evaluated in three randomized, double-blind, placebo-controlled studies....