Epidiolex: Cost, Side Effects, Dosage, and More

Epidiolex is a brand-name prescription drug. It's used to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. These rare but severe conditions usually appear in early childhood or infancy.

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 children ages 2 and older.

In clinical studies, Epidiolex reduced the number of seizures in people taking the drug. During these studies, most people were taking Epidiolex in combination with at least two other epilepsy drugs. The studies showed that:

• people with Lennox-Gastaut syndrome who were taking Epidiolex had 20% to 25% fewer seizures than people not taking the drug
• people with Dravet syndrome who were taking Epidiolex had 26% fewer seizures than people not taking the drug

FDA approval

Epidiolex was approved by the Food and Drug Administration (FDA) in June 2018. It was the first drug approved to treat Dravet syndrome.

A new kind of drug

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

You may wonder if Epidiolex will act like marijuana in your or your child's body. Marijuana contains two main drugs: tetrahydrocannabinol (THC) and cannabidiol (CBD). These drugs have different effects on the body. THC can make you feel 'high' or euphoric. CBD doesn't make you feel that way.

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

Is Epidiolex a controlled substance?

Yes, Epidiolex is a controlled substance. This means it can cause dependence, and its use is regulated by the federal government.

Epidiolex is classified as a schedule five (V) prescription drug. Drugs with a higher classification (such as schedule five drugs) have a lower risk of being misused than drugs with a lower classification (such as schedule one drugs). This means that Epidiolex has a low risk of being misused.

Epidiolex is available only as a brand-name medication. It's not currently available in generic form.

Epidiolex contains the active ingredient cannabidiol.

As with all medications, the cost of Epidiolex can vary. To find current prices for Epidiolex in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance coverage and the pharmacy you use.

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.

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 does not 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.

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)

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk to 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:

• liver problems
• sedation (sleepiness, loss of coordination, and trouble thinking clearly)
• severe allergic reaction
• suicidal thoughts or behavior

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.

During clinical trials, about 12% of people taking Epidiolex had fatigue (low energy levels). And between 3% and 6% of people taking the drug felt sedated during clinical studies. 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)

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

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

Avoid using machinery (such as driving a car) 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 the following sleep problems:

• 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, between 9% and 20% 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.

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, almost 16% of people taking the drug had high blood levels of liver enzymes. High levels of liver enzymes in the blood can mean there is a problem with the liver.

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 the most common reason 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.

Your doctor may test your liver function before and during your Epidiolex treatment. 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.

Suicidal thoughts and behavior

Epidiolex and other anti-epilepsy medications 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 were not taking these drugs. The risk was increased after just one 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.

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 four months of treatment:

• 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

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.

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

• your or your child's weight
• the severity of the condition you're using Epidiolex to treat
• your or your child's liver function
• other medications you or your child are 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 mL of Epidiolex solution contains 100 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 is prescribed in doses of milligrams (mg) of medication per kilogram (kg) of body weight. One kilogram of body weight is equal to 2.2 pounds of body weight. Your dosage will be written as mg/kg.

Dosage for seizures (Lennox-Gastaut syndrome or Dravet syndrome)

Recommended (standard) 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 your dosage after you or your child takes the starting dose for one 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

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 are not 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 two rare and severe forms of epilepsy:

• Lennox-Gastaut syndrome. It causes seizures that usually begin in early childhood or infancy.
• Dravet syndrome. It causes seizures that usually begin in infancy.

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

Epidiolex is approved for use in adults and children ages 2 and older with these conditions.

Epidiolex for other conditions

Epidiolex is the first FDA-approved drug made with cannabidiol (CBD). It's only approved to treat seizures caused by Dravet syndrome and Lennox-Gastaut syndrome.

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 'Epidiolex for treating pain' section 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 is not 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 marijuana. 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 tuberous sclerosis

Epidiolex isn't approved to treat tuberous sclerosis. However, in one small clinical study, the following results were seen in people with this condition:

• those who took CBD had almost 50% fewer seizures after three months of treatment
• about half of those taking CBD had 50% fewer seizures after one year of treatment

People in this study taking CBD in combination with a seizure drug called clobazam had even fewer seizures during treatment.

Epidiolex hasn't been proven safe or effective for treating tuberous sclerosis. 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 marijuana. 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 Lennox-Gastaut syndrome or Dravet syndrome. It can be given to children ages 2 years and older.

Epidiolex isn't FDA-approved to treat pain. Epidiolex is made from cannabidiol (CBD). This compound is a drug that comes from marijuana (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, THC (a drug that also comes from cannabis), CBD together with THC, or a placebo (no treatment). 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.

Epidiolex is FDA-approved to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. These rare but severe conditions usually appear in early childhood or infancy.

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 for Epidiolex

In clinical trials, people with Lennox-Gastaut syndrome who were treated with Epidiolex had fewer seizures than people who did not take the drug. During the 14-week study:

• people who took 20 mg/kg of Epidiolex daily had up to 25% fewer seizures
• people who took 10 mg/kg of Epidiolex daily had 20% fewer seizures

Another 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 did not 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, Sympazam)
• valproate (Depacon)
• levetiracetam (Keppra, Roweepra)
• lamotrigine (Lamictal)
• topiramate (Topamax, Trokendi XR)
• stiripentol (Diacomit)
• rufinamide (Banzel)

Ongoing clinical trials

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

• anxiety
• bipolar depression
• alcohol use disorder in people with post-traumatic stress disorder
• Crohn's disease
• Parkinson's disease
• psoriatic arthritis

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.

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:

• valproate/valproic acid (Depacon, Depakene)
• lamotrigine (Lamictal)
• topiramate (Topamax, Trokendi XR, Qudexy XR)
• clobazam (Onfi, Sympazan)
• rufinamide (Banzel)
• felbamate (Felbatol)

Alternatives for Dravet syndrome

Some experts recommend the following drugs to treat Dravet syndrome:

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

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 FDA-approved to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. It's 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 were not 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 marijuana (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 marijuana (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.

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 marijuana (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 FDA-approved to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. These rare but severe conditions usually appear in early childhood or infancy.

Epidiolex can be used to treat adults and children ages 2 years and older.

Charlotte's Web products are not 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 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. To find out about cost for Epidiolex in your area, visit WellRx.com.

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.

In addition to Charlotte's Web (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's also available as the brand-name drug Depakene.

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 seizure disorders caused by Lennox-Gastaut syndrome and Dravet syndrome. It's approved for use in adults and children ages 2 years and older.

Valproic acid 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, or as an injection given in the hospital.

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:
  • insomnia (trouble sleeping)
  • 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:
  • pancreas problems, such as pancreatitis
  • bleeding disorders, such as low platelet levels and inability to form blood clots when bleeding
  • high ammonia levels in the blood
  • hypothermia (severely low body temperature)
• Can occur with both Epidiolex and valproic acid:
  • liver problems
  • suicidal thoughts or behavior
  • sedation (with symptoms such as sleepiness and loss of coordination)
  • serious allergic reaction

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 brand-name form (Depakene) and in a generic form.

According to estimates on WellRx.com, Epidiolex generally costs more than Depakene or its generic form (valproic acid). The actual price you'll pay for any drug will depend on your dosage, insurance plan, location, and the pharmacy you use.

Epidiolex vs. topiramate

Epidiolex contains the drug cannabidiol (CBD). This drug comes from marijuana (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 seizure disorders caused by Lennox-Gastaut syndrome and Dravet syndrome. It's approved to treat adults and children ages 2 years and older.

Topiramate is FDA-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 migraines 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
  • insomnia (trouble sleeping)
• 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:
  • liver problems
• Can occur with topiramate:
  • vision problems and eye problems, such as glaucoma
  • high fever
  • 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
  • kidney stones
  • hypothermia (very low body temperature)
• Can occur with both Epidiolex and topiramate:
  • suicidal thoughts or behavior
  • 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).

According to estimates on WellRx.com, Epidiolex generally costs more than the brand-name or generic forms of topiramate. The actual price you'll pay for any drug will depend on your insurance plan, your location, and the pharmacy you use.

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 is a list of medications that can interact with Epidiolex. This list does not 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.

Certain seizure medications

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

Some examples of interactions with seizure medications include:

• Clobazam (Onfi, Sympazan). Taking Epidiolex with clobazam can increase blood levels of clobazam. 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 (Depakene, Depacon). 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 are taking for seizure control. This will help prevent dangerous side effects and make sure the drugs are as effective as possible.

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 are taking. This will help make sure the drugs are as effective as possible and will help you avoid dangerous side effects.

Certain antifungal medications

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

• itraconazole (Omnel, 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:

• kava
• melatonin
• SAMe
• valerian root
• L-tryptophan

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.

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 avoid these effects.

You or your child should take Epidiolex according to your doctor or healthcare provider's instructions.

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, eating foods high in calories or fat can increase the amount of Epidiolex that 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.

Measuring a dose

When using a new bottle of Epidiolex, follow these steps:

1. Gather your supplies:
   • bottle of Epidiolex
   • oral syringe
   • bottle adapter
2. Remove the child-resistant cap from the Epidiolex bottle. Do this by pushing down on the cap while turning it counterclockwise (to the left).
3. Place the bottle adapter over the open bottle. Push it down until it's fully inserted. (Skip this step for all future uses with this bottle.)
4. Push the plunger on the syringe all the way down inside the syringe.
5. Insert the tip of the syringe fully into the bottle adapter.
6. Turn the bottle upside down, keeping the syringe inserted in the adapter.
7. Slowly pull on the syringe plunger to withdraw the dose of Epidiolex needed. The end of the plunger inside the syringe should line up at the marking for the dose needed.
8. If you see air bubbles in the syringe, push the plunger back into the syringe (this will push all the medication back into the bottle). Repeat step 7 until the air bubbles are gone.
9. When you have measured the correct dose, turn the bottle right side up.
10. Carefully pull back on the syringe to remove the syringe from the adapter.

Taking a dose

1. Take (or give) the dose by placing the tip of the syringe on the inside of your or your child's cheek. Gently push the plunger until all the medication is pushed out of the syringe. Swallow the medication.
2. Replace the cap back onto the bottle. Leave the adapter in place on the bottle.
3. Clean the syringe by doing the following:
   • Fill a cup with warm soapy water.
   • Place the syringe into the water and pull the plunger in and out to draw water in and out of the syringe.
   • Remove the plunger from the syringe and rinse both the plunger and syringe under water (do not place them into a dishwasher).
   • Shake off any extra water and allow the syringe and plunger to dry separately.
4. Before the next use, make sure the syringe is completely dry. (If there is water in the syringe, the next dose of Epidiolex measured out might look cloudy.)

Epidiolex is approved to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

Epidiolex contains the drug cannabidiol (CBD), which comes from marijuana (cannabis). Unlike THC, another compound in marijuana, 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 four 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.

Epidiolex is a controlled substance. This means it can cause dependence, and its use is regulated by the federal government.

Epidiolex is classified as a schedule five (V) prescription drug. Drugs with a higher classification (such as schedule five drugs) have a lower risk of being misused than drugs with a lower classification (such as schedule one drugs). This means that Epidiolex has a low risk of being misused.

Epidiolex is the only FDA-approved medication made from CBD. All other drugs made with CBD are classified as schedule one (I) drugs. They're not approved by the FDA for medical treatment. However, in some U.S. states, it's legal to use these products for medical use.

If you travel to other U.S. states and use Epidiolex, it helps to be familiar with the legal status of CBD in those states. Epidiolex is legal for use in all states if you have a prescription for it. However, CBD products other than Epidiolex are illegal in many states.

The U.S. government has special rules in place for all controlled substances. These rules help ensure safety when controlled drugs are prescribed and dispensed. If you'd like to know more about how controlled substances are handled, talk with your doctor or pharmacist.

All controlled substances, including Epidiolex, need to be stored in a safe, secure place. Carefully storing this drug will help prevent it from being used accidentally by other people (or pets). It will also help prevent anyone from trying to misuse the drug.

Here are answers to some frequently asked questions about Epidiolex.

What drug schedule is Epidiolex?

Epidiolex is classified as a schedule five (V) prescription drug. Drugs with a higher classification (such as schedule five drugs) have a lower risk of being misused than drugs with a lower classification (such as schedule one drugs). This means that Epidiolex has a low risk of being misused.

Epidiolex is the only FDA-approved medication made from cannabidiol (CBD). 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

All other drugs made with CBD are classified as schedule one (I) drugs. These drugs are not approved by the federal government for medical treatment. However, in some U.S. states, it's legal to use these products for medical use.

Can Epidiolex make you get high?

No, Epidiolex doesn't make you feel 'high' or euphoric.

Epidiolex contains a drug called cannabidiol (CBD). This drug comes from marijuana (cannabis). It doesn't make you feel intoxicated. Tetrahydrocannabinol (THC) is a drug that also comes from marijuana (cannabis). 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.

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 clinical studies. About 1% of people in the clinical studies died.

Epidiolex was not 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.

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.
• 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