Epidiolex

Epidiolex is a prescription cannabidiol (CBD) oral solution developed by Greenwich Biosciences (formerly GW Pharmaceuticals). It contains highly purified CBD derived from cannabis and is formulated in sesame oil as a clear, tasteless suspension. CBD does not produce the intoxicating effects associated with THC and is considered non-psychoactive at therapeutic doses.

Indications: In the United States, Epidiolex is approved for adjunctive therapy of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients aged 2 years and older.

Dosing and administration: It is taken by mouth twice daily. The recommended starting dose is 2.5 mg/kg/day in two divided doses, with gradual uptitration to a target maintenance dose of up to 10 mg/kg/day, as tolerated and in consideration of potential drug interactions and adverse effects. Dosing should be individualized and supervised by a physician. It is typically used in combination with other anti-epileptic medications.

Pharmacology and interactions: Epidiolex is a CBD product with a mechanism of antiseizure action that is not fully understood. It is metabolized by hepatic enzymes (CYP3A4 and CYP2C19) and can interact with concomitant anti-epileptic drugs such as clobazam and valproate, potentially affecting drug levels and adverse effects. Liver function monitoring is commonly advised during treatment, particularly when used with valproate.

Adverse effects: Common adverse effects include somnolence, sedation, diarrhea, decreased appetite, and fatigue. Serious risks include elevations in liver enzymes, especially with valproate coadministration. Patients should seek medical advice for signs of liver injury or allergic reactions.

Regulatory status: Epidiolex is FDA-approved for the specified epilepsies and is a Schedule V controlled substance in the United States. It is available by prescription only.