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What Is Epidiolex?

a box and bottle of Epidiolex

Epidiolex is an oral solution containing cannabidiol (CBD). It is available on prescription in the US to treat seizures in Dravet syndrome, Lennox-Gastaut syndrome (LGS), or tuberous sclerosis complex (TSC) in those ages one and older. A systematic review including human clinical trials concludes that using oral CBD is associated with reducing seizure frequency in those with Dravet or LGS.

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What Is Epidiolex?

Epidiolex is a pharmaceutical-grade CBD oral solution. It is a clear, colorless-to-yellow liquid containing CBD at a concentration of 100 milligrams per milliliter (100 mg/mL). Other ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.

Epidiolex is the first FDA-approved cannabis-based medication in the US, initially for treating seizures in treatment-resistant forms of Dravet syndrome and LGS. Phase 3 clinical trials were initiated in 2015, and the FDA approved Epidiolex in June 2018. The trials showed a positive result in reducing seizures in children with Dravet syndrome and LGS.

Epidiolex is approved for those with treatment-resistant seizures associated with Dravet, LGS, or tuberous sclerosis complex, but physicians may prescribe it off-label for other conditions.

Epidiolex is made with CBD derived from cannabis instead of being a synthetic cannabinoid. Epidiolex is a 99% pure oral CBD extract and does not contain tetrahydrocannabinol (THC), other cannabinoids, or terpenes.

Epidiolex vs. CBD Oil

Patients have a common question: “Are CBD oil and Epidiolex the same thing?” The answer is “No.”

When people talk about CBD oil, they usually refer to hemp-derived CBD oil that is legally available on the market. However, this is not approved for use for any particular medical condition by the FDA. CBD oils can be CBD-only (CBD isolates), broad-spectrum (CBD and terpenes, with no THC), or full-spectrum (CBD, terpenes, and up to 0.3% THC). Their quality is variable, and how accurate their labels are regarding cannabinoid content is up for debate (i.e., there is no standardization of hemp products).

Although 0.3% THC may not seem like much in theory, it may end up being up to 3 mg of THC per 1000 mg (gram) of product. Again, not necessarily a lot for many, but it can affect some who might be particularly sensitive to THC or need specific, extremely low doses. If large doses are required for any effect in a non-pharmaceutical product (e.g., three 30 ml bottles per day), this can end up being a larger amount of THC being ingested. This can cause great variability in a product’s effects. The fact that so many products are inaccurate in their THC and CBD measurements complicates matters further.

Indeed, one study shows that people who used artisanal CBD had a 70% increase in seizures, whereas people utilizing pharmaceutical-grade CBD showed a reduction in seizures. Although the study’s sample size was small (only 31 people), it is worth bearing in mind that the variability of non-regulated, hemp-derived CBD products and the cannabinoids and terpenes in them play a part in determining what effect they have when ingested.

Uses and Health Benefits

CBD has displayed anti-inflammatory properties on top of its well-established anti-seizure properties, making it helpful in treating many different health problems. But we cannot say whether or not CBD is beneficial for health beyond those established by scientific research.

Check the FDA guidelines for information on dosing Epidiolex here.

Here’s the Epidiolex medication guideline.

Here are the instructions for use.

Adverse Side Effects

Adverse side-effects of Epidiolex can include, but are not limited to:

  • Sedation and sleepiness
  • Fatigue
  • Sleep problems
  • Rash
  • Decreased appetite
  • Nausea and vomiting
  • Diarrhea
  • Fever
  • Infections
  • An increase in liver enzymes
  • Negative interactions with other anti-seizure medications

Potential Interactions

CBD may interact with the following antiepileptic drugs (AEDs):

  • Clobazam
  • Stiripentol
  • Valproic acid and sodium valproate
  • Topiramate
  • Eslicarbazepine
  • Zonisamide
  • Brivaracetam
  • Gabapentin
  • Pregabalin

CBD and medical cannabis may also interact with sedatives and antihistamines with sedative properties like zolpidem (Ambien), eszopiclone (Lunesta), and diphenhydramine (Benadryl). Anti-anxiety medications and antidepressants as well, like alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), sertraline (Zoloft), fluoxetine (Prozac), and escitalopram (Lexapro). CBD may also interact with blood thinners like warfarin.

Check out the Leafwell article for more information on medications cannabis and CBD can interact with.

A more comprehensive list of possible interactions can be seen here.

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Frequently Asked Questions

Is Epidiolex the same as CBD oil?

No, they are not. Epidiolex is FDA-approved and is a pharmaceutical product produced by Greenwich, a subsidiary of GW Pharmaceuticals. CBD oil is not a pharmaceutical product and is not available for prescription, and is not approved for any medical use by the FDA. Although Epidiolex uses cannabis plants for its CBD, the product is made to a different standard compared to hemp-derived CBD oils.

Is Epidiolex a narcotic?

The DEA has descheduled Epidiolex and is not legally considered a “narcotic.” CBD does, however, have psychoactive effects, even if they’re not necessarily intoxicating or psychotropic in the same way THC is. CBD and THC are different compounds and affect the endocannabinoid system (ECS) differently.

In 2019, the Legislature formally rescheduled Epidiolex as a Schedule V controlled substance. On April 6, 2020, the DEA descheduled Epidiolex entirely, meaning it is no longer subject to the Controlled Substances Act (CSA) and its tracking and monitoring requirements. You are legally permitted to cross state lines in the US with Epidiolex in your possession.

Do you need a prescription to get Epidiolex?

Is it possible to test positive for marijuana when using Epidiolex?

There is the possibility of testing positive for marijuana metabolites on urine drug screenings due to Epidiolex use. However, technically this should be unlikely as most drug screenings do not test for CBD. Patients/caregivers should inform the drug testing site that they have a prescription for Epidiolex from their doctor.

Can I or my child get addicted to Epidiolex?

Can I drive under the influence of Epidiolex?

Some people may feel sleepy after consuming Epidiolex (especially if combined with other AEDs, anti-anxiety medications, or alcohol), so it is not advisable to drive if such effects are felt. Many people develop a tolerance to the sedative effects of CBD after taking it for some time so that the sedative effects may subside over time.

Once you start understanding how Epidiolex affects you after ingestion, you can judge what you can do with it for yourself.

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