Epidiolex

Definition: Epidiolex is a prescription oral solution of purified cannabidiol (CBD) and the first FDA-approved drug made from a substance purified from the cannabis plant. It treats seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients 1 year and older. It does not contain THC and doesn’t cause a high.

What Does Epidiolex Treat?

The FDA approved Epidiolex in June 2018 for seizures linked to Lennox-Gastaut syndrome and Dravet syndrome in patients 2 and older. It was also the first FDA-approved treatment specifically for Dravet syndrome. In 2020, the FDA added tuberous sclerosis complex and lowered the minimum age to 1 year.

How Does Epidiolex Work?

According to its FDA label, the exact way CBD reduces seizures is unknown. It doesn’t appear to work through the cannabinoid receptors that THC uses. Researchers think it calms overactive nerve signaling through several other targets.

What Are the Side Effects of Epidiolex?

The most common side effects in clinical trials included sleepiness, reduced appetite, diarrhea, raised liver enzymes, fatigue, rash, and trouble sleeping. Liver enzyme increases are more likely at higher doses and in patients also taking valproate, so doctors check liver function before and during treatment. Epidiolex can also raise blood levels of some other seizure medicines, like clobazam.

Is Epidiolex the Same as Store-Bought CBD?

No. Epidiolex is a pharmaceutical-grade product made to strict FDA standards, with a consistent, verified dose. Over-the-counter CBD products vary widely in strength and purity and haven’t been tested or approved for seizures. Never swap a prescribed seizure medication for a retail CBD product.

Is Epidiolex a Controlled Substance?

No. The DEA removed Epidiolex from federal drug control in 2020, so it’s handled like other prescription medicines. It was developed by GW Pharmaceuticals, now part of Jazz Pharmaceuticals.

Related terms: Cannabidiol (CBD), Dravet Syndrome, Lennox-Gastaut Syndrome, FDA

Sources: FDA: Epidiolex Prescribing Information; FDA: Regulation of Cannabis and Cannabis-Derived Products.

This entry is for general education and isn’t medical advice. Talk to a neurologist about seizure treatment.