Individuals experiencing epileptic seizures may be given a prescription for Epidiolex to help alleviate the symptoms of their disease. Read more about Epidiolex, its uses, side effects, and legality.

What Is Epidiolex?

Epidiolex is an oral medication containing a purified form of cannabidiol (CBD), a chemical compound of the Cannabis sativa plant(1).

CBD is purported to have anti-inflammatory, anti-anxiety, anti-cancer, anti-nausea, and anticonvulsant (anti-seizure) properties(2).

Although CBD comes from cannabis plants, such as hemp and marijuana, it does not cause intoxication and is non-psychoactive(3). These properties make CBD different from tetrahydrocannabinol (THC), a cannabis compound known to cause a feeling of getting “high.”

Epidiolex is the first cannabis-based drug approved by the Food and Drug Administration (FDA) to treat patients with Dravet syndrome(4).

Uses of Epidiolex

Epidiolex is a medication for treating seizures caused by two rare types of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome(5).

Dravet syndrome is a rare genetic disorder usually affecting children. It is characterized by fever-related seizures or involuntary muscle spasms.

Children with Dravet syndrome may experience hyperactivity, poor language and motor skills development, and difficulty communicating with others(6).

Individuals with Lennox-Gastaut syndrome may have frequent seizures and difficulty controlling muscle activity. Children with this disorder may develop learning problems and intellectual disabilities(7).


To prepare and administer Epidiolex, individuals should follow these steps(8):

1. Put the adapter on the bottle: Remove the bottle cap and push the bottle adapter into the bottle. The adapter must not be removed once inserted.

2. Prepare the correct dose: Press the syringe plunger down and insert the syringe into the adapter. Rotate the bottle upside down and pull the plunger slowly.

The plunger end should align with the dose marking. Afterward, place the bottle right side up and carefully remove the syringe.

3. Administer the dose: Place the syringe tip against the inside of the cheek. Push the plunger gently until the syringe is empty.

Product Dosage

Epidiolex has a standard dosing recommendation of 5 milligrams (mg) per kilogram (kg) of body weight per day, or 2.5mg/kg taken twice daily(9).

For individuals who need to increase the dosage, the recommended titration for Epidiolex is a weekly increment increase of 5mg/kg per day(10).

Individuals prescribed to take Epidiolex must follow their doctor’s dosage prescription.

Side Effects of Epidiolex

Despite its purported benefits, Epidiolex use may still come with some adverse reactions, including(11):

  • Somnolence (drowsiness)
  • Appetite loss
  • Diarrhea
  • Fatigue, asthenia (lack of energy), or malaise (general discomfort)
  • Rashes
  • Sleep disorders like insomnia and poor sleep quality


Individuals must take note of the following precautions before considering taking Epidiolex(12):

  • Transaminase elevation: Transaminase is a liver enzyme synthesizing amino acids and forming them into proteins.

Taking Epidiolex may cause transaminase elevation, characterized by excessive transaminase enzymes in the body.

  • Sedation and somnolence: Individuals taking Epidiolex are advised not to operate heavy equipment or machinery to minimize the risk of accidents due to drowsiness.
  • Hypersensitivity reactions: Individuals experiencing hypersensitivity due to Epidiolex must discontinue using the drug and seek immediate medical care.


As of February 2022, the pricing of a 100mg/ml Epidiolex oral solution is as follows(13):

  • 60ml bottle: $974.16
  • 100ml bottle: $1,617.26

Prices may vary depending on the pharmacy or dispensary. Factors such as stock shortages and other inventory or shipping issues may affect the product’s retail cost.

Epidiolex Expiration, Storage, and Disposal

Epidiolex must be stored at room temperature, between 68°F to 77°F (20°C to 25°C)(14). The bottle must be tightly closed and kept out of reach of children.

An unopened Epidiolex bottle has a 24-month expiration date(15). Users are warned not to use Epidiolex after the date of expiry.

Epidiolex must be used within 12 weeks after the first opening of the bottle. Afterward, any remaining Epidiolex must be safely disposed of or thrown away(16).


Epidiolex may interact with the CYP3A4 and CYP2C19 liver enzymes, necessary to metabolize various drugs(17).

This interaction may affect CBD plasma concentrations in the body, resulting in an increased risk for developing side effects or reduced Epidiolex efficacy.

Epidiolex Clinical Trials

Two randomized and placebo-controlled studies were conducted to determine the effectiveness of Epidiolex on Lennox-Gastaut syndrome patients aged 2 to 55 years(18).

Researchers of both studies observed a reduction in seizures within the first four weeks of Epidiolex treatment. The effects were generally consistent during the 14-week trial period.

Another randomized, placebo-controlled study was conducted on patients 2 to 18 years old and diagnosed with Dravet syndrome(19).

The study showed that Epidiolex may help reduce convulsive seizures within the first four weeks of treatment. Effects of Epidiolex generally remained consistent within the 14-week treatment period.

Epidiolex and Pregnancy

There is insufficient data regarding the developmental risks of Epidiolex on pregnant women. However, animal studies showed that CBD may cause developmental toxicity in pregnant animals.


1. Is Epidiolex similar to CBD oil?

Epidiolex is an FDA-approved prescription medication and the brand name of the CBD oil manufactured by Greenwich Biosciences(20).

CBD oil is the general term for any cannabis-based oil product containing CBD. Except for Epidiolex, most CBD products are unregulated and may have varying levels of THC(21).

2. How long does Epidiolex take to work?

CBD in Epidiolex has a maximum plasma concentration time of about 2.5 to 5 hours(22). Time of maximum plasma concentration is the duration for a drug to reach its highest concentration in the body after administration.

Epidiolex is a Schedule V prescription medication approved by the FDA, making the drug legal at the federal level(23). State permits are not necessary to take Epidiolex.

  1. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy
  2. Page 105 of Healing With CBD
  3. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy
  4. Ibid.
  5. Ibid.
  6. Ibid.
  7. Ibid.
  8. How to Take Epidiolex
  9. EPIDIOLEX® (cannabidiol) offers flexible dosing for tolerability and response optimization
  10. Ibid.
  11. Highlights of Prescribing Information – EPIDIOLEX (cannabidiol) oral solution
  12. Ibid.
  13. Epidiolex Prices, Coupons and Patient Assistance Programs
  14. Your Easy Guide to Epidiolex
  15. Ibid.
  16. Highlights of Prescribing Information – EPIDIOLEX (cannabidiol) oral solution
  17. Ibid.
  18. Ibid.
  19. Ibid.
  20. Epidiolex (Cannabidiol) Primer: Frequently Asked Questions for Patients and Caregivers
  21. Ibid.
  22. Highlights of Prescribing Information – EPIDIOLEX (cannabidiol) oral solution
  23. Epidiolex (Cannabidiol) Primer: Frequently Asked Questions for Patients and Caregivers
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