Have you ever wondered about the difference between Epidiolex, the first cannabidiol-based prescription medication, and the CBD oils lining store shelves? If cannabidiol (CBD) is the active ingredient in Epidiolex, how is it different from the many CBD oil products you can buy without a prescription?

Epidiolex and over-the-counter CBD products have important differences that can affect how they work for seizures. Continue reading to learn more about the differences between CBD oils and Epidiolex.

What Is CBD?

CBD is a chemical found in the cannabis sativa plant. Although tetrahydrocannabinol (THC) is found in the same plant, CBD doesn’t make you feel “high,” like THC does. CBD can be isolated from either:

• Hemp plants (plants with less than 0.3 percent THC)
• Marijuana plants (plants with more than 0.3 percent THC)

When CBD is isolated from the plant, it can be put in other products, such as oils, capsules, gummies, or creams. CBD has been studied for potential health benefits for certain medical conditions. In studies, it’s shown promise for helping some people with conditions including:

• Anxiety
• Difficulty falling or staying asleep
• Chronic pain
• Addiction

CBD has shown its most convincing results in treating epilepsy in children. In fact, the evidence was so strong that the U.S. Food and Drug Administration (FDA) approved Epidiolex to treat seizures associated with severe forms of epilepsy such as Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex (a condition that causes noncancerous tumors).

8 Differences Between CBD Oil and Epidiolex

Although cannabidiol is the active ingredient in both CBD oil and Epidiolex, there are several key differences.

1. FDA Approval

Epidiolex is currently the only FDA-approved CBD product available. This means that the FDA has evaluated Epidiolex for the following factors:

• How well it works for epilepsy
• Safest and most effective dose
• Drug interactions (for instance, with other antiepileptic drugs)
• Side effects
• Safety concerns

Other CBD oils haven’t gone through this rigorous process because there are no other CBD-containing products approved or regulated by the FDA. The FDA is aware that other companies have marketed CBD products to treat medical conditions like epilepsy and has sent warning letters for them to stop.

2. Legality

You can be sure it’s legal to have and use Epidiolex with a valid prescription because it’s an FDA-approved medication. The 2018 Farm Bill made hemp and hemp products legal. However, laws about the use of CBD vary from state to state. Talk to your doctor to learn more about the laws about CBD in your state.

It’s important to note that you may test positive during a cannabis drug test while taking either CBD or Epidiolex. If you need a drug test, you should tell the testing center that you are currently taking Epidiolex as prescribed by your doctor.

3. Dosage

The dosage and how often you take CBD oil products versus Epidiolex may vary. Your doctor will determine your dose of Epidiolex based on your weight. The appropriate dosage has been carefully studied through clinical trials to be the most effective while causing the fewest side effects possible. Additionally, it can take time to find the right dosage for you. A MyEpilepsyTeam member shared, “It took me a long time to get to the dosage for Epidiolex I am at.”

Your dose for other CBD oil products may not be as clear. Talk to your doctor before starting any new medication or supplement, like CBD oil. Your doctor can help you find the safest and most effective dose.

4. Side Effects

The side effects of a CBD oil product and Epidiolex may be different. The FDA has only limited data about the side effects of CBD products. Possible side effects of CBD include:

• Liver damage
• Drowsiness
• Diarrhea
• Changes in appetite
• Irritability

Because Epidiolex has been studied in clinical trials, there is much more information about the potential side effects.

5. Manufacturing

Epidiolex is manufactured to comply with the strict regulations of the FDA’s current Good Manufacturing Practices. This means that each batch of Epidiolex has no more and no less than what’s listed on the label.

Additionally, the CBD used to make Epidiolex comes from hemp plants that are grown specifically to make a high amount of CBD. The CBD isolated for use in Epidiolex is pure CBD.

The cannabis plants used to make Epidiolex are grown in a regulated environment and are free from:

• Pesticides
• Heavy metals
• Contaminants

Other CBD oil products don’t have to follow the same federal manufacturing standards as Epidiolex. Without high manufacturing standards, there may be different amounts of the active ingredient in the product or contaminants. This means that even if you’ve found a product that works for you, another batch of the same product may be different.

A 2022 study of 121 edible CBD products found that these products are frequently contaminated with toxic metals such as lead, mercury, arsenic, and cadmium.

6. Inactive Ingredients

An inactive ingredient is any ingredient other than the active ingredient in a drug product. Some inactive ingredients of CBD oil may affect overall treatment, especially if you’re following a special diet.

Epidiolex is formulated without sugar or carbohydrates. This makes it compatible with epilepsy diets, such as a ketogenic diet. Inactive ingredients in Epidiolex include:

• Alcohol
• Sesame seed oil
• Strawberry flavor
• Sucralose

Inactive ingredients can also cause allergic reactions if you have food allergies.

7. Accurate Labeling

Labeling may not be accurate for CBD oils sold over the counter. A 2017 study published in JAMA found that only about 30 percent of CBD products analyzed were accurately labeled. Researchers found that almost 70 percent of the products had significantly less CBD or more CBD than stated on the label. Additionally, about 21 percent of the products contained THC, which could cause additional side effects, such as feeling high.

To help avoid CBD oil products with inaccurate labeling or contaminants, look for a certificate of analysis from an outside laboratory (also known as third-party testing). A certificate of analysis can give you information about the quality and purity of CBD oil.

8. Insurance Coverage

Epidiolex is available as a prescription you can fill at a specialty pharmacy with a valid prescription from your doctor. Many insurance plans may cover Epidiolex for its FDA-approved indications.

CBD oil products are not FDA-approved medications and, therefore, are not covered by insurance plans. Unlike Epidiolex, CBD oil can be purchased in many places, including online, specialty stores, and even grocery stores or gas stations in some states.

Talk to Your Doctor

Talk to your doctor to find out if Epidiolex may be a good option for you or whether it’s safe for you to try CBD oil. Always be open and honest with your doctor about everything you’re taking — including over-the-counter medications, vitamins, and other supplements like CBD oil. Your doctor can help guide you on what dose to take and help prevent drug interactions and serious side effects.

Find Your Team

MyEpilepsyTeam is the social network for people with epilepsy and their loved ones. On MyEpilepsyTeam, more than 120,000 members come together to ask questions, give advice, and share their stories with others who understand life with epilepsy.

Do you or your child take CBD oil or Epidiolex for epilepsy? Did it take time to find the right dosage? Share your experience in the comments below, or start a conversation by posting on your Activities page.