Paul Gavin has made reference on a couple of occasions to the reported side effect of somnolence in patients using Epidiolex, the only currently FDA-approved CBD therapy (~ US$1bn annual sales).
In the pivotal, double-blind, placebo-controlled trial of Epidiolex in Dravet syndrome, 120 children and young adults received either 20mg/kg CBD or placebo, dosed twice daily, over 14 weeks.
The most common adverse event was somnolence, reported in 36% of the CBD group compared with 10% in the placebo group.
Last year, consensus panel recommendations for the optimization of Epidiolex treatment were published. The consensus panel consisted of seven neurologists specialized in the field.
One of the recommendations to reduce potential side effects of the therapy was as follows:
Anecdotally, Epidiolex 10–20 mg/kg/day given as a single dose in the evening may mitigate daytime somnolence and sedation. Once-daily dosing in the evening with high-fat content food may also improve sleep onset among pediatric patients at night and alleviate daytime sedation.
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