The emergence of CBD in professional healthcare and everyday wellness has brought many life-changing cannabis products to consumers. As the spotlight continues to grow on the potential health benefits of the drug Cannabidiol, it is important to understand the distinctions between prescription medicine CBD and over-the-counter CBD products.
What is Epidiolex?
Epidiolex is a brand-name drug and the only FDA-approved prescription medicine that is entirely cannabis-derived. It is made from a pharmaceutical-grade CBD isolate extract that’s 98% pure. The isolate powder is then infused into a keto-friendly sesame oil base. Epidiolex is essentially a pure isolate CBD oil approved for use in adults and children ages one and older. Talk to your doctor if your child is younger than age one, as there are currently no safety studies for children this age.
The US Food and Drug Administration has approved Epidiolex as a medical treatment for the following indications:
- Seizures associated with a severe form of epilepsy called Lennox-Gastaut syndrome
See clinical studies - Seizures associated with a severe form of epilepsy called Dravet syndrome
See clinical trials - Tuberous sclerosis complex (TSC)
See clinical study
You cannot experience intoxication or feelings of being “high” after taking Epidiolex because it does not contain THC, the psychoactive chemical in marijuana that may cause mind-altering side effects at high levels.
Always take Epidiolex as your doctor prescribes. Abruptly stopping Epidiolex or other antiepileptic drugs may increase seizure frequency and risk of potentially serious side effects, including a life-threatening medical condition called status epilepticus. Do not discontinue taking Epidiolex without first talking to your prescribing doctor.
What is the difference between Epidiolex vs CBD oil?
FDA-approved Epidiolex is different from CBD oils for sale online or at your local nutrition store.
Here are three ways that Epidiolex vs CBD differ from each other:
- FDA-approved seizure medicine
The US Food and Drug Administration approves Epidiolex to treat certain conditions. Over-the-counter CBD has not received FDA approval to diagnose, treat, cure, or prevent any disease. - Highly purified and lab-tested for safety
Epidiolex is >98% pure CBD isolate, whereas most over-the-counter medicines are made from full spectrum CBD extracts that range in CBD potency and purity (60% to 95%). CBD potency and purity depend on several factors, including the source of raw cannabis material, the extraction process, and whether the products are third-party lab-tested to verify cannabinoid content. - Backed by clinical studies
The US Food and Drug Administration requires drug companies to demonstrate product effectiveness in controlled clinical trials before receiving drug approval for medical treatment of specific health conditions. The drug Cannabidiol in CBD products may have clinical trials and studies that support its benefits for everyday wellness concerns like anxiety, depression, pain, and migraine headaches, but not enough scientific study to pass FDA muster.
You should not use over-the-counter CBD as a substitute for prescription Epidiolex because no clinical studies show it to be an adequate replacement for the drug.
Directions for use
Read the entire Epidiolex medication guide before taking it for the first time. This guide contains important safety information when adding prescription CBD medicine to your or your child’s treatment plan.
Epidiolex is an oral solution with >98% pure CBD isolate infused into a sesame oil base. Use the one or five mL syringes included with your medication to administer the best dose by mouth.
How much Epidiolex you need per dose depends on your current body weight. Epidiolex dosage administration is in mg per kg (or lbs). Therefore, the usual adult dose will vary from the usual pediatric dose in children.
Your doctor prescribes the correct dose of Epidiolex. Always follow your provider’s dosage instructions. Take Epidiolex as soon as possible if you miss a dose. If it’s already time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not double up on doses.
RELATED INFORMATION: Over-the-counter CBD starting dose calculator
Caregivers and healthcare providers often use a calculator to determine the correct initial dose of the active ingredient in Epidiolex, the drug cannabidiol. It is crucial to follow the administration guidelines the patient’s doctor provides carefully.
Price information
The price of Epidiolex can be pretty expensive, depending on several factors, such as the country you reside in, the pharmacist you go to fill your prescription, your insurance company’s health coverage, and potential rebates available when your doctor prescribes it.
The actual price for this drug is subject to changes over time. Check your local pharmacies, call your insurance company, and visit the Epidiolex website for assistance programs or discounts currently offered to potential patients.
Side effects & interactions
Common side effects of taking Epidiolex include drowsiness, appetite changes, diarrhea, gastrointestinal upset, or sleep problems. Adverse reactions to prescription medicine Epidiolex may go away with time.
Alert your prescribing doctor if you experience any signs or symptoms of liver problems while taking Epidiolex. Certain side effects may indicate a more serious adverse reaction or underlying health condition. Watch for loss of appetite, weight loss, nausea, vomiting, fever, rash, yellowing of the skin or whites of the eyes, dark urine, or infections. Even though liver problems are a rare side effect, your doctor may want regular blood tests while you take Epidiolex. This may be especially important if you have liver damage or liver disease.
Epidiolex can affect the way other medicines work and vice versa. You should not start or stop the other prescription drugs you take without talking to your healthcare provider first. Remember to tell your doctor about all your medications, including prescription and OTC medicines, vitamins, herbal supplements, or other cannabis-based products. Your doctor will determine if there are any potential risks for interactions based on this important information.
Precautions before taking this prescription drug
According to the official website, people should not take Epidiolex if allergic to the active drug Cannabidiol or any ingredients used in the product.
Allergic reaction to Epidiolex is an uncommon side effect. However, your risk of experiencing an adverse event may increase if you have a hypersensitivity to other food, prescription or OTC medicine, herbs, or supplements.
Share any new or unusual changes in your health state with your doctor. Epidiolex may cause suicidal thoughts in some patients. Tell your doctor if you have depression, anxiety, significant changes in mood or outlook, or other mental health symptoms.
Tell your doctor about any liver injury or liver function issue you may have before beginning Epidiolex, as it may cause liver problems in rare instances.
Women taking Epidiolex
Researchers don’t know whether taking Epidiolex during pregnancy can harm your unborn baby. You and your provider must decide if you should continue taking the drug while pregnant. If you become pregnant while taking Epidiolex, consider signing up for the North American Antiepileptic Drug Pregnancy Registry (by calling +1-888-233-2334).
Epidiolex passes into breast milk. Talk to your doctor about the best way to feed your baby while taking it.
Wrapping up: Final thoughts on Epidiolex
Epidiolex stands as the only FDA-approved cannabis medication targeted for severe epilepsy brought on by Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. However, doctors do not yet know if the combination of CBD with common seizure medications or the CBD itself is responsible for the effect. The precise mechanism of action is still being studied.
The prescription medicine Epidiolex plays a specific role in treating particular seizure disorders. It clearly distinguishes itself from over-the-counter CBD products, which people commonly use to address everyday wellness concerns. The FDA does not approve OTC CBD medicines to treat, diagnose, cure, or prevent any disease.
Frequently Asked Questions About Epidiolex vs CBD Oil
Epidiolex — often mistakenly called Epidolex or Epidex — has received FDA approval to treat severe epilepsy conditions. Review these frequent questions and talk to your doctor before adding Epidiolex to your treatment plan.
