Epidiolex is a brand-name prescription drug. It’s FDA-approved to treat seizures caused by three conditions:

For more information about these conditions and how Epidiolex is used to manage them, see the “Epidiolex uses” section below.

Epidiolex active drug ingredient and other details

Epidiolex contains the drug cannabidiol (CBD).

It comes as a liquid solution that’s taken by mouth. Epidiolex is approved for use in adults and in children ages 1 year and older.

FDA approval

In June 2018, Epidiolex was approved by the Food and Drug Administration (FDA). It was the first drug approved to treat seizures in people with Dravet syndrome. At that time, Epidiolex was also approved to treat seizures in people with Lennox-Gastaut syndrome.

Then, in 2020, Epidiolex was approved to treat seizures in people with TSC.

A new kind of drug

Epidiolex contains cannabidiol (CBD), which comes from cannabis (also called marijuana). Epidiolex is the first FDA-approved drug made from cannabis.

You may wonder if Epidiolex will act like cannabis in your or your child’s body. Cannabis contains two main compounds: tetrahydrocannabinol (THC) and cannabidiol (CBD). These compounds have different effects on the body. THC can make you feel “high” or euphoric. But CBD doesn’t make you feel that way.

Epidiolex contains only CBD. It doesn’t contain any THC, so it won’t make you feel “high.”

Is Epidiolex classified as a controlled substance? If so, what’s its schedule?

When it was first approved for use in 2018, Epidiolex was a controlled substance. But as of April 2020, Epidiolex is no longer a controlled substance. A controlled substance is a drug that can be misused or cause dependence. And its use is regulated by the federal government.

At the time of its approval, Epidiolex was classified as a schedule V prescription drug. Drugs with a higher classification (such as schedule V) have a lower risk of being misused than drugs with a lower classification (such as schedule I). With misuse, a drug is used in a way other than how it was prescribed.

For controlled substances, federal and state laws restrict the number of refills that can be given for the drug. The laws also restrict the ability to transfer prescriptions between pharmacies.

Now that the FDA has removed Epidiolex from its list of controlled substances, it’s easier for doctors to prescribe the medication. The change will also help people more easily fill and transfer their prescriptions for Epidiolex.

For more information, see the section “Epidiolex isn’t a controlled substance” below.

Effectiveness

In clinical studies, Epidiolex was effective in reducing the number of seizures in people taking the drug. For more information about Epidiolex’s effectiveness, see the “Epidiolex clinical trials” section below.

Epidiolex contains the active ingredient cannabidiol. It’s available only as a brand-name medication. It’s not currently available in generic form. (A generic drug is an exact copy of the active drug in a brand-name medication.)

Epidiolex can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Epidiolex. This list doesn’t include all possible side effects.

For more information on the possible side effects of Epidiolex, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Epidiolex, you can do so through MedWatch.

More common side effects

The more common side effects of Epidiolex can include:

  • fatigue (lack of energy)
  • drowsiness
  • feeling weak
  • malaise (generally not feeling well)
  • loss of appetite
  • diarrhea
  • skin rash
  • insomnia (trouble sleeping)
  • infections (such as viral or fungal infections)

If these side effects become severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Epidiolex aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects, explained in more detail below in “Side effect details,” include the following:

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Epidiolex. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • trouble breathing

Call your doctor right away if you or your child has a severe allergic reaction to Epidiolex. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Drowsiness

Drowsiness was a common side effect in people taking Epidiolex during clinical studies. Up to 25% of people taking the drug felt unusually sleepy. Of people taking a placebo (treatment with no active drug), 9% felt sleepy.

Also during clinical trials, up to 12% of people taking Epidiolex had fatigue (low energy levels). And up to 4% of people taking a placebo had fatigue.

In addition, between 3% and 6% of people taking Epidiolex felt sedated during clinical studies. Of people taking a placebo, 1% felt sedated. Symptoms of sedation can include:

  • sleepiness
  • loss of coordination
  • trouble thinking clearly
  • being unable to safely operate equipment or machinery, such as driving a car

In general, people taking higher doses of Epidiolex felt drowsy, fatigued, or sedated more often than people taking lower doses of Epidiolex.

If you or your child has any of these side effects after taking Epidiolex, talk with your doctor. They may need to change your dose of Epidiolex or have you try a different medication.

Avoid using machinery while taking Epidiolex until you know how the drug will affect you.

Sleep problems

In clinical studies, between 5% and 11% of people taking Epidiolex had certain sleep problems. And 4% of people taking a placebo (treatment with no active drug) had certain sleep problems. The sleep problems reported included:

  • insomnia (trouble falling asleep or staying asleep)
  • poor quality of sleep
  • sleep disruption

Sleep problems were more common in people taking lower doses of Epidiolex than in people taking higher doses of the drug.

If you or your child has trouble sleeping while using Epidiolex, talk with your doctor about ways to improve your sleep.

Diarrhea

In clinical studies, up to 31% of people who took Epidiolex had diarrhea. People taking higher doses of Epidiolex had diarrhea more often than people taking lower doses of the drug. In comparison, between 9% and 25% of people taking a placebo (treatment with no active drug) had diarrhea.

If you or your child has diarrhea while using Epidiolex, talk with your doctor. They can recommend ways to help relieve this side effect.

Liver damage

Liver damage has occurred in people taking Epidiolex. In clinical studies, between 8% and 25% of people taking the drug had high levels of liver enzymes. (High levels of liver enzymes in the blood can mean there is a problem with the liver.) In comparison, up to 3% of people taking a placebo (treatment with no active drug) had high levels of liver enzymes.

Symptoms of liver problems can include:

  • nausea
  • vomiting
  • pain in your upper abdomen (belly)
  • fatigue (lack of energy)
  • loss of appetite
  • jaundice (yellowing of your skin and the whites of your eyes)
  • dark-colored urine

In clinical studies, people taking higher doses of Epidiolex had liver problems more often than people taking lower doses of the drug. Liver damage was one of the most common reasons for people stopping use of Epidiolex during clinical studies.

If you have liver disease, you may have a higher risk of having liver damage while taking Epidiolex. Be sure to review your medical history with your doctor before starting Epidiolex.

Before you start using Epidiolex, your doctor will test your liver function. This helps them make sure your liver is healthy enough for you to use this drug. During Epidiolex treatment, your doctor may continue to monitor your liver function with lab tests.

If you develop liver damage during treatment, you may need to stop taking the drug. Let your doctor know if you have any symptoms of liver problems during your treatment with Epidiolex.

Weight loss

Weight loss was reported during clinical studies of Epidiolex. People taking higher doses of Epidiolex noticed more weight loss than people taking lower doses.

After almost 4 months of treatment:

  • 31% of people taking 25 milligrams per kilogram (mg/kg) of Epidiolex per day lost at least 5% of their body weight
  • 18% of people taking 20 mg/kg of Epidiolex per day lost at least 5% of their body weight
  • 9% of people taking 10 mg/kg of Epidiolex per day lost at least 5% of their body weight
  • 8% of people taking a placebo (treatment with no active drug) each day lost at least 5% of their body weight

Loss of appetite is a possible side effect of Epidiolex. Between 16% and 22% of people taking Epidiolex had decreased appetite during clinical studies. Weight loss in people taking Epidiolex could result from lack of appetite.

If you’re concerned about weight loss while taking Epidiolex, talk with your doctor about ways to help you or your child maintain a healthy weight.

Suicidal thoughts and behavior

Epidiolex can increase the risk of suicidal thoughts and behavior. Other medications used to treat epilepsy (anti-epilepsy drugs) also increase this risk.

An analysis by the FDA looked at several studies done in people using anti-epilepsy drugs. Eleven different drugs were studied.

This analysis found that people treated for epilepsy had an increased risk of suicidal thoughts and behavior. The risk in people taking anti-epilepsy drugs was 80% higher than the risk in people who weren’t taking these drugs. The risk was increased after just 1 week of taking the medications.

These studies were done before Epidiolex became available. It’s not known for sure how often people taking Epidiolex have suicidal thoughts or behavior.

During treatment with Epidiolex, your doctor will monitor you or your child closely for signs of new or worsening depression or unusual mood changes. Talk with your doctor right away if you notice these signs in yourself or your child, or if you have thoughts of harming yourself.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

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As with all medications, the cost of Epidiolex can vary. The actual price you’ll pay depends on your insurance coverage and the pharmacy you use.

You may need to get Epidiolex from a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Epidiolex, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if they will cover the drug.

If you’re not sure if you’ll need to get prior authorization for Epidiolex, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Epidiolex, or if you need help understanding your insurance coverage, help is available.

Greenwich Biosciences, the manufacturer of Epidiolex, offers a program called Epidiolex Copay Savings Program. For more information and to find out if you’re eligible for support, call 833-426-4243 or visit the program website.

The Epidiolex dosage your doctor prescribes will depend on several factors. These include:

  • your or your child’s weight
  • the condition related to your or your child’s seizures
  • the severity of the condition that Epidiolex is being used to treat
  • your or your child’s liver function
  • other medications you or your child is taking

Typically, your doctor will start you or your child on a low dosage and adjust it over time to reach the dosage that works best. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes. Your doctor will determine the best dosage to suit your or your child’s needs.

Drug forms and strengths

Epidiolex comes as a strawberry-flavored liquid solution that’s taken by mouth. It’s available in a 100-mL bottle. Each milliliter (mL) of Epidiolex solution contains 100 milligrams (mg) of active drug.

You or your child will take the liquid solution using a plastic oral syringe. You use this device to measure the amount of medication, and to release the solution into your or your child’s mouth. This drug can be taken using a 1-mL or a 5-mL syringe. Your pharmacist will give you the right-sized syringe for your prescribed dose of Epidiolex.

Epidiolex dosages are calculated in mg of medication per kilogram (kg) of body weight. (One kg is equal to 2.2 pounds.) Your dosage will be calculated by your doctor or pharmacist.

Dosage for seizures due to Lennox-Gastaut syndrome or Dravet syndrome

Recommended dosages for people with seizures caused by Lennox-Gastaut syndrome or Dravet syndrome are listed below.

  • Starting dosage: 2.5 mg/kg taken by mouth twice daily
  • Maintenance dosage: 5 mg/kg taken by mouth twice daily
  • Maximum dosage: 10 mg/kg taken by mouth twice daily

Your doctor may increase Epidiolex dosages after you or your child takes the starting dose for 1 week. Dosages are increased depending on how well the drug is tolerated and if it’s working well.

Your doctor may prescribe a different dosage depending on several factors, including whether you have liver disease. If you have questions about the dosage that’s right for you, talk with your doctor.

Dosage for seizures due to tuberous sclerosis complex

Recommended dosages for people with seizures caused by tuberous sclerosis complex (TSC) are listed below.

  • Starting dosage: 2.5 mg/kg taken by mouth twice daily
  • Maintenance dosage: 12.5 mg/kg taken by mouth twice daily

Your doctor may increase the Epidiolex dosage after you or your child takes the starting dose for 1 week. Dosages are increased depending on how well the drug is tolerated and if it’s working well.

Your doctor may prescribe a different dosage depending on several factors, including whether or not you have liver disease. If you have questions about the dosage that’s right for you, talk with your doctor.

Children’s dosage

The dosage of Epidiolex for children is the same as it is for adults. See the sections just above for more details.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip your missed dose. Just take your next dose at the regular time.

If you aren’t sure about whether you should take a missed dose, call your doctor’s office.

Don’t take more than one dose of Epidiolex at the same time. Doing this can increase your risk of serious side effects.

Will I need to use this drug long term?

Epidiolex is meant to be used as a long-term treatment. If you and your doctor determine that Epidiolex seems to be safe and effective, you or your child will likely take it long term.

The Food and Drug Administration (FDA) approves prescription drugs such as Epidiolex to treat certain conditions. Epidiolex may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Epidiolex for seizures and epilepsy

Epidiolex is FDA-approved to treat seizures caused by three rare conditions:

  • Lennox-Gastaut syndrome. This is a type of epilepsy that causes seizures that usually begin in early childhood or infancy.
  • Dravet syndrome. This is also a type of epilepsy. It causes seizures that usually begin in infancy.
  • Tuberous sclerosis complex (TSC). TSC causes a variety of symptoms, which may include seizures. And these seizures typically develop during childhood.

These three conditions can be very difficult to treat. People with seizures related to these conditions often need more than one medication to reduce the number of seizures they have.

Epidiolex is approved for use in adults and in children ages 1 year and older with these conditions.

Epidiolex for other conditions

Epidiolex is the first FDA-approved drug that’s made with cannabidiol (CBD). It’s only approved to treat seizures caused by Dravet syndrome, Lennox-Gastaut syndrome, or TSC.

Many studies are looking at other ways CBD could be used for medical treatment. Some of these possible uses are described below.

Epidiolex for pain

Epidiolex isn’t approved to treat pain. Animal studies have shown that CBD may help relieve pain. However, fewer studies have looked at the safety and effectiveness of CBD for treating pain in humans. For more information, see the section “Epidiolex for treating pain” below.

Epidiolex for anxiety

Epidiolex isn’t approved to treat anxiety. However, several studies have shown that CBD may improve anxiety by reducing anxious feelings during stressful times.

Epidiolex hasn’t been proven safe or effective for treating anxiety. Only use Epidiolex as directed by your doctor.

Epidiolex for autism

Epidiolex isn’t approved to treat autism. Only a few studies have looked at using CBD to treat autism. In one clinical study of children with autism, CBD reduced symptoms of:

  • aggression
  • anxiety
  • hyperactivity

Epidiolex hasn’t been proven safe or effective for treating autism. Only use Epidiolex as directed by your doctor.

Epidiolex for schizophrenia

Epidiolex isn’t approved to treat schizophrenia. In several small studies, CBD reduced schizophrenia symptoms in some people. However, other studies haven’t shown an improvement in symptoms after treatment with CBD.

Epidiolex hasn’t been proven safe or effective for treating schizophrenia. Only use Epidiolex as directed by your doctor.

Epidiolex for migraine

Epidiolex isn’t approved to treat or prevent migraine. Few studies have looked at the use of CBD for migraine treatment.

In some clinical studies, CBD helped to reduce the number of migraine headaches in people using the drug. In these studies, CBD was used in combination with tetrahydrocannabinol (THC).

Similar to CBD, THC is a compound that comes from cannabis. THC can cause you to feel “high” or euphoric. These effects aren’t caused by CBD.

Epidiolex hasn’t been proven safe or effective for treating migraine. Only use Epidiolex as directed by your doctor.

Epidiolex for infantile spasms

Epidiolex isn’t approved to treat infantile spasms. Only one small clinical study looked at using CBD to treat this condition. For almost all of the infants in the study, CBD didn’t improve their symptoms.

Epidiolex hasn’t been proven safe or effective for treating infantile spasms. Only use Epidiolex as directed by your doctor.

Epidiolex for multiple sclerosis

Epidiolex isn’t approved to treat multiple sclerosis (MS). There isn’t much known about using CBD alone to treat MS.

Several studies have looked at using a combination of CBD and tetrahydrocannabinol (THC) to treat MS. Similar to CBD, THC comes from cannabis. However, THC can cause you to feel “high” or euphoric. These side effects aren’t caused by CBD.

In studies of people with MS taking CBD and THC, some symptoms improved during treatment. Symptoms that improved included:

  • muscle spasticity (stiff or contracting muscles)
  • urinary incontinence (loss of urinary control)
  • generalized pain

Epidiolex hasn’t been proven safe or effective for treating MS. Only use Epidiolex as directed by your doctor.

Epidiolex for children

Epidiolex is FDA-approved for use in children to treat seizures caused by three rare conditions. For more information on these conditions, see the beginning of this “Epidiolex uses” section.

Epidiolex can be given to children ages 1 year and older.

Epidiolex isn’t approved by the Food and Drug Administration (FDA) to treat pain. Epidiolex is made from cannabidiol (CBD). This compound comes from cannabis. CBD has been studied as a treatment for pain in both animals and humans.

The exact way that CBD reduces pain isn’t known. It’s thought that CBD blocks certain pain signals traveling through the body’s nerves. This may help to reduce the pain you actually feel. CBD also helps to stop inflammation that can happen after nerves are irritated by pain.

Several animal studies have looked at using CBD to treat pain. In these studies, CBD reduced pain in animals that had nerve pain caused by chemotherapy (a type of cancer treatment) or joint pain caused by arthritis.

One small study looked at using CBD to treat people with pain caused by nerve disease or nerve damage. People in this study were given either CBD, tetrahydrocannabinol (THC) (a compound that also comes from cannabis), CBD together with THC, or a placebo (treatment with no active drug). The results showed the following:

  • those who took CBD alone had less pain each day than people taking the placebo
  • those who took CBD in combination with THC had fewer muscle spasms and better sleep than people taking CBD alone or people taking the placebo (there were no significant results in this group showing a reduced pain level)

Many other studies have found that the combination of CBD and THC helps to reduce pain caused by some diseases and injuries. More research is needed to know if CBD treatment alone reduces pain.

You may wonder how Epidiolex compares to other products made from cannabis. Here we look at how Epidiolex and Charlotte’s Web are alike and different.

Ingredients

Epidiolex contains the drug cannabidiol (CBD). This drug comes from cannabis. CBD doesn’t make you feel “high” or euphoric.

Charlotte’s Web refers to many different products that contain chemicals from hemp plants. These drugs could include CBD and small amounts of tetrahydrocannabinol (THC). You can feel “high” or euphoric after using THC.

Charlotte’s Web may also contain other chemicals depending on the type of product and where it is purchased. It’s not known if these other chemicals are safe for use in people.

Uses

Epidiolex is approved to treat seizures caused by three conditions:

Epidiolex can be used to treat seizures caused by these conditions in adults and in children ages 1 year and older.

Charlotte’s Web products aren’t FDA-approved to treat medical conditions. By law, makers of Charlotte’s Web can’t claim that the product treats or cures any disease.

Charlotte’s Web products are sometimes used to help support health and well-being. Some people use these products to help increase calmness, improve focus, or reduce stress. It’s important to remember that the safety and effectiveness of Charlotte’s Web have not been proven.

Drug forms and administration

Epidiolex comes as a strawberry-flavored liquid solution. It contains 100 milligrams (mg) of CBD per milliliter (mL) of solution. Epidiolex is taken by mouth twice daily.

Charlotte’s Web products are available as oral capsules, oils, creams, and balms. Products come in many different doses, ranging from 6 mg to 60 mg of CBD per mL of product.

Side effects and risks

Epidiolex is an FDA-approved drug. This means that side effects caused by Epidiolex have been reported in clinical studies. It also means that Epidiolex has been proven safe and effective to treat certain conditions.

Charlotte’s Web products haven’t been studied in clinical trials. Side effects of Charlotte’s Web haven’t been reported and aren’t known for sure.

Because of this, it’s not possible to compare the side effects of Epidiolex and Charlotte’s Web.

Effectiveness

Charlotte’s Web hasn’t been studied in clinical trials. Because of this, it’s not possible to compare the effectiveness of Charlotte’s Web to the effectiveness of Epidiolex.

Costs

Epidiolex is a brand-name drug. There are currently no generic forms available. Brand-name medications usually cost more than generics.

Charlotte’s Web is available as a variety of products. Prices vary for the different products.

Epidiolex is an FDA-approved drug used for medical treatment. It may be covered by health insurance. Charlotte’s Web is not an FDA-approved medical treatment. It’s not covered by health insurance.

Here are answers to some frequently asked questions about Epidiolex.

How do I know that Epidiolex is safe to use?

Epidiolex contains the drug cannabidiol (CBD), which comes from cannabis. But Epidiolex doesn’t contain other compounds found in cannabis, such as tetrahydrocannabinol (THC). (THC can made you feel intoxicated.)

Epidiolex is the only medication made from cannabidiol (CBD) that’s approved by the Food and Drug Administration (FDA). This approval ensures the quality, safety, and effectiveness of Epidiolex. For example, because Epidiolex has been approved by the FDA, you can be assured that the drug:

  • contains the exact amount of CBD that the manufacturer says it does
  • is proven safe to treat seizures caused by certain conditions
  • is effective in treating seizures caused by certain conditions

Can Epidiolex make you get high?

No, Epidiolex doesn’t make you feel “high” or euphoric.

Epidiolex contains a compound called cannabidiol (CBD). This compound comes from cannabis. It doesn’t make you feel intoxicated. Tetrahydrocannabinol (THC) is a compound that also comes from cannabis. And THC can make you feel “high.”

Epidiolex doesn’t contain any THC. It only contains CBD.

Is Epidiolex use legal?

Yes, it’s legal to use Epidiolex if your doctor has prescribed it for you or your child. Epidiolex is an FDA-approved drug, just like any other medication that your doctor prescribes.

It’s also legal to carry Epidiolex when you travel, including on airplanes. The Transportation Security Administration (TSA) knows that Epidiolex is an FDA-approved medication. (The TSA oversees security for air travel.)

If you’re on the ketogenic diet, can you take Epidiolex?

Yes, you can use Epidiolex if you’re on a ketogenic diet. But you should talk with your doctor about how your diet can affect the medication. Eating meals high in fat can increase the amount of Epidiolex that your body absorbs. This can increase the level of Epidiolex in your system.

In clinical studies, Epidiolex levels were increased up to five times when the drug was taken with a high-fat meal.

Higher levels of Epidiolex in the body can increase your risk of side effects. These can include:

  • drowsiness
  • sleepiness
  • diarrhea
  • skin rash

If you’re on a ketogenic diet, your doctor will monitor your side effects. They may recommend a different dose of Epidiolex or changes in your diet.

Have there been deaths reported with use of Epidiolex?

In total, 1,756 people took Epidiolex during initial clinical studies. About 1% of the people in the clinical studies died.

Epidiolex wasn’t found to be the cause of death in these people. Many of those who died had several complicated diseases. Some of these diseases increase the risk of death.

Also, the number of deaths in these studies was similar to the number of deaths in people who have either Lennox-Gastaut syndrome or Dravet syndrome.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Epidiolex, talk to your doctor to learn more about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions.

Alternatives for Lennox-Gastaut syndrome

Treatment guidelines recommend the following drugs to treat Lennox-Gastaut syndrome:

Alternatives for Dravet syndrome

Some experts recommend the following drugs to treat Dravet syndrome:

  • valproate/valproic acid
  • clobazam (Onfi, Sympazan)
  • stiripentol (Diacomit)
  • topiramate (Topamax, Trokendi XR, Qudexy XR)
  • clonazepam (Klonopin)
  • levetiracetam (Keppra, Roweepra, Spritam)
  • zonisamide (Zonegran)

Alternatives for seizures related to tuberous sclerosis complex

Some experts recommend the following drugs to treat seizures associated with tuberous sclerosis complex:

  • vigabatrin
  • everolimus

Use with other drugs

Epidiolex is commonly prescribed with other drugs when used to treat seizures. Many of the drugs listed above can be used in combination with Epidiolex. Your doctor will recommend which drugs can be used together based on your condition.

Non-FDA-approved CBD products

Epidiolex is the only drug containing cannabidiol (CBD) that’s approved for medical use by the FDA.

The quality, safety, and effectiveness of a drug can be ensured by FDA-approval. Because Epidiolex has been approved by the FDA, you can be assured that the drug:

  • contains the exact amount of CBD that the manufacturer says it does
  • is proven safe to treat certain seizure disorders
  • is effective to treat certain seizure disorders

Other products made with CBD are available to purchase, but they haven’t been approved by the FDA. This means that the FDA can’t guarantee that those products have a safe amount of CBD. It also means the effectiveness of those products hasn’t been tested.

One study looked at products containing CBD that weren’t FDA-approved. The study found that only 31% of those products contained the amount of CBD listed on their label. Of the remaining 69% of products:

  • 43% had more CBD than the label stated
  • 26% had less CBD than the label stated

The labels for these products didn’t state that they contained tetrahydrocannabinol (THC). However, about 21% of the products did contain THC. This chemical is found in cannabis. THC can make you feel “high” or euphoric.

Certain U.S. states have laws that require products containing CBD to be tested before they’re sold. States that haven’t made cannabis legal for medical or recreational use don’t have these laws. This means that products containing CBD might not be tested before they’re sold in some areas of the United States.

Be sure you’re familiar with state laws before you purchase any products containing CBD. This will help you make sure that you buy products from safe and reputable companies that have had their products tested.

Epidiolex and alcohol don’t interact with each other. But they can both cause similar effects in your body, including:

  • drowsiness
  • sleepiness
  • loss of coordination
  • trouble thinking clearly

Drinking alcohol while taking Epidiolex can worsen these side effects. To reduce your risk of having these effects, you should avoid drinking alcohol while using Epidiolex.

If you have trouble avoiding alcohol, talk with your doctor.

Epidiolex can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Epidiolex and other medications

Below are some of the medications that can interact with Epidiolex. This section doesn’t contain all drugs that may interact with Epidiolex.

Before taking Epidiolex, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Epidiolex and certain seizure medications

Taking Epidiolex with certain seizure medications can increase the risk of side effects and change how the medications work.

Some examples seizure medications that may interact with Epidiolex include:

  • Clobazam (Onfi, Sympazan). Taking Epidiolex with clobazam can increase your blood levels of clobazam’s active metabolite (the form of the drug that’s been metabolized by your body). This increases the risk of certain side effects of clobazam. If you need to take these drugs together, your doctor may prescribe a lower dosage of clobazam.
  • Valproate/valproic acid. Taking Epidiolex with valproate or valproic acid can increase the risk of liver problems. If you take these drugs together, you may need a lower dosage of either drug.
  • Diazepam (Diastat, Valium). Taking Epidiolex with diazepam can increase blood levels of diazepam. This increases the risk of certain side effects. You may need a lower dosage of diazepam if you’re taking it with Epidiolex.
  • Phenytoin (Dilantin, Phenytek). Taking Epidiolex with phenytoin may affect the levels of either drug. This could increase the risk of certain side effects and decrease the effectiveness of each drug. If you take these drugs together, your doctor will closely monitor you for side effects and seizures. Your dosage of phenytoin may need to be adjusted if they’re taken together.

There may be other seizure medications in addition to these that can interact with Epidiolex. Be sure to tell your doctor and pharmacist about all of the medications you’re taking for seizure control. This will help prevent dangerous side effects and make sure the drugs are as effective as possible.

Epidiolex and certain antiviral medications

Taking Epidiolex with certain antiviral medications can change levels of either drug in the body. This can make the medications more or less effective. It can also increase the risk of side effects.

Examples of antiviral drugs that may interact with Epidiolex include:

  • ritonavir (Norvir; ingredient in combination tablets)
  • cobicistat (Tybost; ingredient in combination tablets)
  • elvitegravir (ingredient in Genvoya, Stribild)
  • lopinavir (ingredient in Kaletra)
  • ombitasvir (ingredient in Technivie, Viekira XR)
  • dasabuvir (ingredient in Viekira XR)
  • efavirenz (Sustiva; ingredient in Atripla, Symfi)

Many of these drugs are part of combination tablets (tablets made from more than one drug). Be sure to tell your doctor or pharmacist about all of the antiviral medications you’re taking. This will help make sure the drugs are as effective as possible and will help you avoid dangerous side effects.

Epidiolex and certain antifungal medications

Taking Epidiolex with certain antifungal medications can increase the risk of side effects. Examples of these antifungal drugs include:

  • itraconazole (Onmel, Sporanox, Tolsura)
  • ketoconazole (Extina, Nizoral, Xolegel)
  • posaconazole (Noxafil)
  • voriconazole (Vfend)

Talk with your doctor or pharmacist about all antifungal medications you take. They can make sure the drugs won’t interact with Epidiolex. This will help you decrease your risk of certain side effects.

Epidiolex and herbs and supplements

Taking Epidiolex with certain herbs or supplements, such as St. John’s wort, can lower Epidiolex levels in your body. This may reduce how effective Epidiolex is in treating seizures.

Other herbs and supplements can make you feel extra drowsy or sleepy if they’re taken with Epidiolex. Examples of these include:

Talk with your doctor about any herbs or supplements you take. They may recommend that you stop taking certain products that cause drowsiness and products that affect how well Epidiolex works for you.

Epidiolex and foods

Eating meals with large amounts of fat or calories can increase the amount of Epidiolex that your body absorbs. This can increase your risk of side effects, such as drowsiness, diarrhea, rash, and trouble sleeping.

It’s important to eat similar amounts of fat and calories at each meal. This will help keep a stable level of Epidiolex in your body and reduce your risk of side effects. If you have questions about your diet, talk with your doctor.

Epidiolex is approved to treat seizures caused by three conditions:

For more information about these conditions, see the “Epidiolex uses” section above.

Before Epidiolex was approved, it was tested in clinical trials. Its active ingredient, cannabidiol, is currently being tested in clinical trials for other uses.

Clinical trials of Epidiolex in people with Lennox-Gastaut syndrome

In clinical trials, people with Lennox-Gastaut syndrome who took Epidiolex had fewer seizures than people who didn’t take the drug. During the 14-week study:

  • half of the people who took 20 milligrams (mg) per kilogram (kg) of Epidiolex daily had 42% to 44% fewer seizures
  • half of the people who took 10 mg/kg of Epidiolex daily had 37%% fewer seizures
  • half of the people who took a placebo (treatment with no active drug) had 17% to 22% fewer seizures

Clinical trials of Epidiolex in people with Dravet syndrome

A clinical trial lasting 14 weeks looked at people with Dravet syndrome. This trial included children and teenagers. People who took Epidiolex had 26% fewer seizures than people who didn’t take the drug. The dosage of Epidiolex given in this trial was 20 mg/kg daily.

All of the people in both of these clinical trials were taking Epidiolex in combination with other epilepsy drugs. Examples of epilepsy medications given include:

  • clobazam (Onfi, Sympazan)
  • valproate
  • levetiracetam (Keppra, Roweepra, Spritam)
  • lamotrigine (Lamictal)
  • topiramate (Topamax, Trokendi XR, Qudexy XR)
  • stiripentol (Diacomit)
  • rufinamide (Banzel)

Clinical trials of Epidiolex in people with TSC

In clinical trials, people with TSC who took Epidiolex had fewer seizures than people who didn’t take the drug. During the 16-week study:

  • half of the people who took 25 mg/kg of Epidiolex daily had 43% fewer seizures
  • half of the people who took a placebo (treatment with no active drug) had 20% fewer seizures

In this study, almost everyone included took other seizure medications with either Epidiolex or the placebo.

Ongoing clinical trials

Cannabidiol (the active ingredient in Epidiolex) is currently being tested in clinical trials as a treatment option for other conditions. Research is being done for the following conditions:

Many ongoing studies for other conditions are also being done. If you’d like to participate in a study, look for clinical trials in your area at clinicaltrials.gov.

In addition to Charlotte’s Web (described above), other medications are also used to treat conditions similar to those treated by Epidiolex. Below are comparisons between Epidiolex and several medications.

Epidiolex vs. valproic acid

Epidiolex contains the drug cannabidiol (CBD). Valproic acid is a generic drug. It also used to be available as the brand-name drug Depakene. But that medication has been discontinued.

Uses

Epidiolex and valproic acid are both used to treat epilepsy (a disorder that causes seizures). However, they are FDA-approved to treat different forms of epilepsy.

Epidiolex is approved to treat seizures caused by three conditions:

It can be used to treat seizures caused by these conditions in adults and in children ages 1 year and older.

Valproic acid, on the other hand, is approved to treat:

  • complex partial seizures in people ages 10 years and older
  • simple or complex absence seizures in people of all ages

Valproic acid can be used alone or with other seizure medications.

Drug forms and administration

Epidiolex is a strawberry-flavored liquid solution, taken by mouth twice daily.

Valproic acid comes as capsules that are taken by mouth, one to three times daily. It’s also available as a syrup that can be taken by mouth. In addition, valproic acid comes as a solution that’s given by injection in a hospital. (This injectable medication is called valproate sodium.)

Side effects and risks

Epidiolex and valproic acid both work to treat seizures. They can cause some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Epidiolex, with valproic acid, or with both drugs (when taken individually).

  • Can occur with Epidiolex:
    • infections, such as viral or fungal infections
    • malaise (generally not feeling well)
  • Can occur with valproic acid:
    • nausea
    • headache
    • dizziness
    • vomiting
    • pain in your abdomen (belly)
    • blurry vision or double vision
    • increased appetite
    • weight gain
    • problems with coordination or walking
    • hair loss
  • Can occur with both Epidiolex and valproic acid:
    • sleepiness
    • feeling weak
    • loss of appetite
    • diarrhea

Serious side effects

These lists contain examples of serious side effects that can occur with Epidiolex, with valproic acid, or with both drugs (when taken individually).

  • Can occur with Epidiolex:
    • no unique serious side effects
  • Can occur with valproic acid:
    • bleeding disorders, such as low platelet levels and inability to form blood clots when bleeding
    • high ammonia levels in the blood
    • birth defects*
  • Can occur with both Epidiolex and valproic acid:
    • suicidal thoughts or behavior
    • sedation (with symptoms such as sleepiness and loss of coordination)

* Valproic acid has a boxed warning for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.

Effectiveness

In separate studies, Epidiolex and valproic acid reduced the number of seizures in people taking each drug. However, there aren’t any studies that have directly compared Epidiolex to valproic acid.

Costs

Epidiolex is a brand-name drug. There are currently no generic forms of Epidiolex available. Brand-name medications usually cost more than generic drugs.

Valproic acid is available in a generic form.

Epidiolex generally costs more than valproic acid. The actual price you’ll pay for any drug depends on your dosage, insurance plan, location, and the pharmacy you use.

Epidiolex vs. topiramate

Epidiolex contains the drug cannabidiol (CBD). This drug comes from cannabis. CBD doesn’t make you feel “high” or euphoric.

Topiramate is a generic drug. It’s also available in brand-name forms (Topamax, Qudexy XR, Trokendi XR).

Uses

Epidiolex and topiramate are both used to treat epilepsy (a disorder that causes seizures). They are both FDA-approved to treat Lennox-Gastaut syndrome, but also have other unique uses.

Epidiolex is approved to treat seizures caused by three conditions:

It can be used to treat seizures caused by these conditions in adults and in children ages 1 year and older.

Topiramate is approved to treat epilepsy, used alone or in combination with other seizure drugs. It’s also approved to treat Lennox-Gastaut syndrome when used in combination with other epilepsy drugs. It can be used in adults and children ages 2 years and older.

Topiramate is also approved to prevent migraine in people ages 12 years and older.

Drug forms and administration

Epidiolex comes as a strawberry-flavored liquid solution, taken twice daily by mouth.

Topiramate comes in tablets and capsules that are taken by mouth. Dosing schedules differ depending on the condition you’re taking topiramate to treat. It’s typically taken twice a day.

Side effects and risks

Epidiolex and topiramate work in different ways to treat seizures. They can cause similar and different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Epidiolex, with topiramate, or with both drugs (when taken individually).

  • Can occur with Epidiolex:
    • feeling weak
    • malaise (generally not feeling well)
    • skin rash
  • Can occur with topiramate:
    • tingling in arms or legs
    • changes in your sense of taste
    • unplanned weight loss
    • feeling nervous
    • trouble speaking
    • memory problems
    • pain in your abdomen (belly)
    • fever
    • vision changes
    • decreased sense of feeling in the skin
    • slow reaction time
  • Can occur with both Epidiolex and topiramate:
    • fatigue (feeling very tired)
    • drowsiness
    • loss of appetite
    • diarrhea
    • infections, including viral infection and pneumonia

Serious side effects

These lists contain examples of serious side effects that can occur with Epidiolex, with topiramate, or with both drugs (when taken individually).

  • Can occur with Epidiolex:
  • Can occur with topiramate:
    • vision problems and eye problems, such as glaucoma
    • hyperthermia (high body temperature) without the ability to sweat
    • increased blood levels of acid
    • increased blood levels of ammonia
    • trouble thinking clearly
    • mood disorders, including depression
  • Can occur with both Epidiolex and topiramate:
    • sedation (with symptoms such as sleepiness and loss of coordination)

Effectiveness

Epidiolex and topiramate are both used to treat Lennox-Gastaut syndrome. They’re also each used to treat other conditions.

Epidiolex and topiramate haven’t been compared directly to each other in clinical studies. However, in separate studies, both drugs reduced the number of seizures in people taking them for treatment.

Costs

Epidiolex is a brand-name drug. There are currently no generic forms of Epidiolex available. Brand-name medications usually cost more than generic drugs.

Topiramate is a generic drug. It’s also available as several brand-name drugs (Topamax, Qudexy XR, Trokendi XR).

Epidiolex generally costs more than the brand-name or generic forms of topiramate. The actual price you’ll pay for any drug depends on your insurance plan, your location, and the pharmacy you use.

You or your child should take Epidiolex according to the instructions of your doctor or another healthcare professional.

Don’t stop taking Epidiolex without talking with your doctor. Stopping it suddenly can cause increased seizures and a dangerous condition called status epilepticus. If you and your doctor decide that you or your child should stop taking Epidiolex, your doctor will slowly reduce the dosage to prevent these effects.

Timing

Epidiolex is taken twice daily. It’s best to take the doses about 12 hours apart.

Taking Epidiolex with food

Epidiolex can be taken with or without food.

Keep in mind that eating foods high in calories or fat can increase the amount of Epidiolex the body absorbs. This can increase the risk of side effects.

Try to eat similar amounts of fat and calories at each meal. This will help keep the level of Epidiolex consistent in your or your child’s body.

Using the Epidiolex syringe

Epidiolex comes with two reusable plastic oral syringes. You’ll use these syringes to measure the exact dose of medication you’re prescribed, and to take the medication into your or your child’s mouth.

You’ll be given two syringes so that you have an extra syringe in case you misplace one. You shouldn’t take Epidiolex with syringes from another medication. Be sure to only use the syringes that come with Epidiolex.

Two different syringe sizes are available: 5 mL and 1 mL. Your pharmacist will give you the right one for your or your child’s dose of Epidiolex.

Don’t use a household measuring device (such as a teaspoon) to measure the Epidiolex dose. These devices don’t always measure the exact amount you need. If you lose the syringes that come with Epidiolex, ask your pharmacist for new ones.

How to take Epidiolex

To find detailed information on how to take Epidiolex, visit the manufacturer’s site. There you’ll find written instructions and helpful videos.

Epidiolex is approved to treat seizures caused by certain conditions. For more information about this, see the “Epidiolex uses” section above.

Epidiolex contains the compound cannabidiol (CBD), which comes from cannabis. Unlike THC, another compound in cannabis, CBD doesn’t make you feel “high” or euphoric.

It’s not known exactly how Epidiolex reduces the number of seizures people have. During a seizure, the brain sends abnormal electrical signals. Epidiolex may work on certain pathways in the brain to prevent these signals from starting and spreading.

How long does it take to work?

Epidiolex typically starts working within days to weeks. In clinical studies, many people had fewer seizures within 4 weeks of starting treatment with Epidiolex.

It isn’t known if Epidiolex is safe to use during pregnancy. Animal studies have shown harm to a growing fetus when the pregnant mother took Epidiolex. However, animal studies don’t always predict what will happen in humans.

If you are pregnant or may become pregnant, talk with your doctor about the benefits and risks of taking Epidiolex in pregnancy.

If you take Epidiolex during pregnancy, you’re encouraged to enroll in a pregnancy registry. The North American Antiepileptic Drug Pregnancy Registry studies how pregnant woman and their babies are affected by epilepsy drugs.

Contact the registry at 888-233-2334 or visit the registry’s website.

It’s not known if Epidiolex passes into breast milk. If you are breastfeeding and considering taking Epidiolex, talk with your doctor. You can discuss the risks and benefits of using Epidiolex while breastfeeding.

When Epidiolex was first approved for use in 2018, it was a controlled substance. But as of April 2020, Epidiolex is no longer a controlled substance. A controlled substance is a drug that can be misused or cause dependence, and its use is regulated by the federal government.

For controlled substances, federal and state laws restrict the number of refills on the drug and the ability to transfer prescriptions between pharmacies. Now that the FDA has removed Epidiolex from its list of controlled substances, it’s easier for doctors to prescribe the drug. The change will also help people more easily fill and transfer prescriptions for Epidiolex.

Even though Epidiolex is no longer a controlled substance, there are still some things to consider if you’re using this drug. These include:

  • Travel. If you travel to other U.S. states and use Epidiolex, it helps to be familiar with the legal status of cannabidiol (CBD) in those states. (CBD, which comes from cannabis, is the active drug in Epidiolex.) Epidiolex is legal for use in all states if you have a prescription for it. However, CBD products other than Epidiolex are illegal in some states.
  • Storage. Epidiolex needs to be stored in a safe, secure place. Carefully storing this drug helps prevent it from being used accidentally by other people (or pets). It also helps prevent someone from trying to misuse the drug. For more information on proper storage of Epidiolex, see the section “Epidiolex expiration, storage, and disposal” below.

Before taking Epidiolex, talk with your doctor about any medical conditions you have. Epidiolex may not be right for you if you have certain conditions. These include:

  • Liver disease. Epidiolex can cause liver damage. People with a history of liver disease may be at greater risk to have liver damage. If you have a history of liver disease, talk to your doctor about whether Epidiolex is right for you. Before starting Epidiolex, your doctor will run certain lab tests to make sure your liver is healthy enough for you to use this medication. And your doctor may continue to monitor your liver function while you’re using the drug.
  • Suicidal thoughts or behavior. Epidiolex (and all anti-epileptic drugs) can increase the risk of suicidal thoughts or behavior. If you have a history of depression or any suicidal thoughts or behavior, talk with your doctor about whether the benefits of taking Epidiolex outweigh the risks.
  • History of serious allergic reaction to Epidiolex. People who have had a serious allergic reaction to cannabidiol or any of the ingredients in Epidiolex should not take Epidiolex.
  • Allergy to sesame seed oil. Epidiolex contains sesame seed oil. If you’re allergic to this oil, you should not take Epidiolex.

Taking too much Epidiolex can increase your risk of serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

  • extreme drowsiness
  • sleepiness or trouble staying awake
  • trouble thinking
  • trouble speaking
  • diarrhea
  • skin rash
  • loss of appetite
  • insomnia (trouble sleeping)

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Epidiolex from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Epidiolex solution should be stored at room temperature (68°F to 78°F/20°C to 25.6°C). Make sure to keep the bottle standing upright and the lid tightly closed. Don’t freeze the medication.

You can use Epidiolex for 12 weeks (3 months) after the bottle is first opened. Discard any medication that’s left over after the bottle has been open for 12 weeks.

Disposal

If you no longer need to take Epidiolex and have left over medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Epidiolex (cannabidiol) has Food and Drug Administration (FDA) approval for the treatment of seizures due to:

  • Lennox-Gastaut syndrome
  • Dravet syndrome
  • tuberous sclerosis complex

It is approved for use in people ages 1 year and older.

Mechanism of action

The mechanism of action of Epidiolex in treating epilepsy is not clear. However, it appears that the anticonvulsant activity of Epidiolex is not related to interaction with cannabinoid receptors in the body.

Pharmacokinetics and metabolism

At steady state, Epidiolex reaches maximum concentration in 2.5 to 5 hours. High-calorie or high-fat meals increase maximum concentration 5-fold, compared to concentration after administration in a fasted state.

Protein binding of the parent drug and metabolites is greater than 94%.

Epidiolex is extensively metabolized by the liver. Metabolism occurs via CYP2C19, CYP3A4, UGT1A7, UGT1A9, and UGT2B7. Moderate to severe hepatic impairment increases blood plasma levels 2.5-fold to 5.2-fold.

The half-life of Epidiolex is between 56 and 61 hours. Elimination occurs primarily in the feces, with significantly less excretion in the urine.

Contraindications

Epidiolex is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the components of Epidiolex.

Epidiolex is contraindicated in patients with a history of hypersensitivity reaction to sesame seed oil.

Abuse and dependence

Upon approval in 2018, Epidiolex was a schedule five (V) controlled substance. However, as of April 2020, the drug is no longer considered a controlled substance.

In clinical studies, there were no reports of abuse or dependence.

As with all anti-epilepsy drugs, abrupt withdrawal should be avoided due to potential for increased seizure frequency and status epilepticus. Gradual titration is recommended.

Storage

Store Epidiolex in an upright position and at room temperature (68°F to 78°F/20°C to 25.6°C) with the cap tightly closed. Do not freeze. Discard any unused solution 12 weeks after first opening.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.