Pronunciation: EH-peh-DYE-oh-lex
Generic name: cannabidiol
Dosage form: oral solution
Drug class: Miscellaneous anticonvulsants

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 29, 2024.

What is Epidiolex?

Epidiolex (cannabidiol) is an oral prescription liquid CBD medicine that may be used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in adults and children aged 1 year and older.

• Epidiolex may help reduce the frequency and severity of seizures.
• Some people may see significant improvements with Epidiolex, while others might not.

Epidiolex contains cannabidiol (CBD), a compound derived from cannabis plants. Scientists are not exactly sure how it works but it does not seem to exert its anticonvulsant effects through interaction with cannabinoid receptors. Unlike tetrahydrocannabinol (THC), which is another compound found in cannabis, Epidiolex does not make people feel "high."

Epidiolex first gained FDA approval on June 25, 2018, and was the first medicine to be approved that was derived from cannabis. It is only available with a doctor's prescription.

Is Epidiolex a controlled substance?

Epidiolex is no longer a controlled substance. On April 6, 2020, Epidiolex was removed by the DEA from Schedule V and rescheduled entirely. It is no longer subject to tracking and monitoring requirements.

Epidiolex side effects

The most common Epidiolex side effects are:

• sleepiness
• decreased appetite
• diarrhea
• increases in liver enzymes
• feeling very tired and weak
• rash
• sleep problems (insomnia)
• fever
• vomiting
• infections.

Serious side effects and warnings

Epidiolex can cause the following serious side effects.

Liver problems. Epidiolex can cause liver enzymes to increase which may result in hospitalization. Increases typically occurred in the first 2 months of treatment although some cases were reported after people had been taking Epidiolex for up to 18 months. Your healthcare provider may order blood tests to check your liver before you start taking Epidiolex and during treatment. In some cases, treatment may need to be stopped. Call your healthcare provider right away if you develop any of these signs and symptoms of liver problems during Epidiolex treatment:

• loss of appetite, nausea, vomiting
• fever, feeling unwell, unusual tiredness
• yellowing of the skin or the whites of the eyes (jaundice)
• itching
• unusual darkening of the urine
• right upper stomach area pain or discomfort.

Sleepiness. Epidiolex may cause you to feel sleepy, which may get better over time. Using certain medicines with Epidiolex such as clobazam or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidiolex affects you.

Like other antiepileptic drugs, Epidiolex may cause suicidal thoughts or actions in a small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempt to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood.

Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled.

Do not stop taking Epidiolex suddenly without first talking to your healthcare provider. Stopping a seizure medicine such as Epidiolex suddenly can cause you to have seizures more often or seizures that do not stop (this is called status epilepticus).

Some people may be allergic to Epidiolex. Get emergency medical help if you have signs of an allergic reaction to Epidiolex, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Do not take Epidiolex if you are allergic to cannabidiol (CBD), sesame seed oil, Epidiolex, or any of the inactive ingredients in the oral solution.

Before taking Epidiolex, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems or suicidal thoughts or behavior.
• have liver problems.
• have abused or been dependent on prescription medicines, street drugs, or alcohol.
• are pregnant or plan to become pregnant
• are breastfeeding.

Epidiolex is not approved for use by anyone younger than 1 year old.

Pregnancy

Based on research in animals, Epidiolex may cause harm to an unborn baby. Tell your healthcare provider right away if you become pregnant while taking Epidiolex. You and your healthcare provider will decide if you should take Epidiolex while you are pregnant.

If you become pregnant while taking Epidiolex, talk to your healthcare provider about registering for both the Epidiolex Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) registry. The purpose of the surveillance program and exposure registry is to collect information about the safety of Epidiolex and other antiepileptic drugs during pregnancy.

You can enroll in the Epidiolex Pregnancy Surveillance Program by calling the toll-free number 1-855-272-7158 or visiting https://www.epidiolexpregnancystudy.com.

You can enroll in the North American Antiepileptic Drug Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org.

Breastfeeding

It is not known if Epidiolex passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Epidiolex.

How should I take Epidiolex?

Take Epidiolex exactly as prescribed by your doctor. Follow all directions on the Epidiolex Package Insert, especially the Instructions for Use. Your doctor may occasionally change your dose.

• Epidiolex is usually taken 2 times a day.
• Take the medicine at the same time each day.

Food can affect Epidiolex levels.

• You may take Epidiolex with or without food, but take it the same way each time.
• If you are not consistent with food then levels of Epidiolex will fluctuate significantly.

Each dose of Epidiolex must be measured exactly.

• Use the bottle adapter and the appropriate dosing syringes that come with Epidiolex.
• This medicine is supplied with 1 mL and 5 mL oral dispensing syringes.
• If your dose of Epidiolex is 1 mL or less, use the 1 mL syringes to take your medicine. Otherwise, use the 5 mL syringe.
• Use a dry syringe each time you take Epidiolex. If water is inside the syringe, it could cause the oil-based medicine to look cloudy.
• Epidiolex may be given through a feeding tube not made of polyvinyl chloride (PVC).
• Epidiolex is strawberry-flavored.

Epidiolex contains cannabidiol which can harm your liver.

• Your liver function may need to be checked before and during treatment.
• You may need to stop taking Epidiolex based on the results.

Epidiolex dosage

The dosage of Epidiolex depends on a person's weight. Epidiolex is taken by mouth (orally).

Usual Adult and Child Dose of Epidiolex for Lennox-Gastaut Syndrome and Dravet Syndrome

Initial dose: Epidiolex 2.5 mg/kg twice a day
-After 1 week, your healthcare provider may increase the dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day
Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.

Usual Adult and Child Dose of Epidiolex for Tuberous Sclerosis Complex

Initial dose: Epidiolex 2.5 mg/kg orally twice a day
-Increase dose in weekly increments of 2.5 mg twice a day (5 mg/kg/day) as tolerated to 12.5 mg/kg twice a day
-For patients requiring a more rapid titration, the dose may be increased no more frequently than every other day
Maintenance dose: 25 mg/kg/day
Maximum dose: 25 mg/kg/day
Comments:
-The effectiveness of doses lower than 25 mg/kg/day has not been studied.

Drug testing

Epidiolex can affect a drug screening test and you may test positive for cannabis (marijuana). Tell the laboratory staff that you use cannabidiol.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Drinking alcohol with Epidiolex can increase drowsiness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

As with most antiepileptic drugs, Epidiolex should not be stopped suddenly due to increased seizure frequency and status epilepticus; the dose can be slowly tapered following your healthcare provider's instructions.

Some people have thoughts about suicide while taking Epidiolex. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

What other drugs will affect Epidiolex?

Using Epidiolex with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• other seizure medications (especially clobazam or valproate); or
• cannabis-based products.

This list is not complete. Many other drugs can interact with cannabidiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using. Click the link below to check for interactions with this medicine.

Storage

• Store Epidiolex at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Always store the bottle in an upright position.
• Do not freeze.
• Keep the child-resistant cap tightly closed.
• Use within 12 weeks of first opening the bottle.
• Throw away any unused medicine after 12 weeks.
• Keep this and all medicines out of the reach of children.

Epidiolex Ingredients

Active ingredient: cannabidiol 100 mg

Inactive ingredients: dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.

Epidiolex is gluten-free, it does not contain wheat, barley, or rye.

Epidiolex is available in 60 mL and 100 mL bottles. The strength of Epidiolex is 100 mg/ mL

Who makes Epidiolex?

Jazz Pharmaceuticals, Inc. makes Epidiolex.

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Further information

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