Your first 90 days
Your first 90 days on Epidiolex for Dravet syndrome
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Jazz Pharmaceuticals describes Epidiolex as the first and only FDA-approved prescription cannabidiol, the plant compound sold in many stores as CBD. The first weeks on Epidiolex center on the dose by weight, liver blood tests and how it works with other seizure medicines. This page walks parents, guardians and caregivers through that stretch. It draws on the FDA label, Jazz Pharmaceuticals' own Epidiolex pages and one insurer's written rules.
What has to happen before the first bottle ships
Epidiolex has no REMS, so the first bottle waits mainly on a liver blood test, a medicine review and an insurance approval. These are the 6 things in the way, in order.
A liver blood test
The label asks for ALT, AST and total bilirubin, which are measures of liver health, in every patient before starting.
- If the results are already high, the prescriber looks for the cause first.FDA label
A full medicine list
Valproate raises the chance of liver enzyme increases, and clobazam adds sleepiness.
- Epidiolex also changes levels of some other medicines, such as everolimus and clopidogrel.
- The neurologist and pharmacist review every medicine and supplement, including other cannabis products.FDA label
A sesame allergy check
Epidiolex contains sesame seed oil and alcohol.
- The label says not to use it in anyone allergic to cannabidiol or any of its ingredients.FDA label
The insurance approval
Plans such as Cigna require prior authorization.
- Cigna's policy asks for a patient 1 or older and a neurologist.
- It also asks that 2 other seizure medicines were tried or are still taken, or one of Fintepla, Diacomit or clobazam.Cigna policy
A specialty pharmacy
Jazz says the prescription goes to a specialty pharmacy that works with the family's insurance.
- The pharmacy calls before shipping, often from a number the family may not recognize, so answering that call avoids delays.How to get Epidiolex
Help paying, from Jazz
Through the JazzCares Copay Savings Program, eligible commercially insured patients may pay as little as $0 per prescription.
- No enrollment is needed, because the pharmacy checks eligibility.
- Medicare, Medicaid and other government plans are not eligible.Copay program
The days that matter
Counted from the first dose, with the weekly dose step the label allows, the liver tests at 1, 3 and 6 months and the 12-week bottle limit. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Baseline liver blood test
ALT, AST and total bilirubin before the first dose.
- The label does not set an exact number of days ahead.
Insurance approval and the pharmacy's call
The plan reviews the prior authorization while the specialty pharmacy confirms coverage, then calls to arrange delivery to the home.
First dose, 2.5mg/kg twice a day
The dose is set by weight and measured with the 1mL or 5mL oral syringe in the carton.
- The label asks for the same timing relative to meals each day.
Possible step to 5mg/kg twice a day
After one week, the label allows an increase to the maintenance dose of 5mg/kg twice a day.
- The neurologist decides whether to raise it.
Further weekly steps, if needed
If seizures need more control and the dose is tolerated, it can rise by 2.5mg/kg twice a day each week, up to 10mg/kg twice a day.
- The label says the higher dose gave somewhat more seizure reduction but more side effects.
Liver blood test
ALT, AST and total bilirubin 1 month after starting.
- The label also asks for a test within 1 month of any dose change.
First refill, timing depends on weight and dose
Bottles hold 60mL or 100mL, at 100mg in each mL.
- How long one lasts depends on the dose, and the pharmacy can say when to reorder.
Throw away the rest of an opened bottle
The label says to use Epidiolex within 12 weeks of first opening the bottle, then discard what is left.
Liver blood test
The second scheduled check after starting.
- Liver enzyme increases in the trials usually appeared in the first 2 months.
Liver blood test, then periodically
After the 6-month check, the label asks for periodic tests or as the prescriber judges necessary.
Insurance renewal
Cigna approves Epidiolex a year at a time.
- Renewal asks that the patient is responding, such as fewer, shorter or milder seizures, as judged by the prescriber.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Epidiolex label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated May 29, 2026, read from the FDA's label database today. FDA label
- June 2026
The FDA approved revisions adding animal study findings for a cannabidiol breakdown product and kidney study results on creatinine, which the label says does not reflect a drop in kidney filtering.Drugs@FDA record
- June 2025
The drug interaction section was updated with results from studies of several liver enzymes.Drugs@FDA record
- March 2024
The pregnancy section added the Epidiolex Pregnancy Surveillance Program, and the liver injury warning was revised.Drugs@FDA record
- June 2018
Epidiolex was first approved on June 25, 2018, for seizures in Lennox-Gastaut syndrome and Dravet syndrome.Drugs@FDA record
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Twice a day, by weight
The label doses Epidiolex in milligrams per kilogram of body weight, twice a day.
- Each mL holds 100mg of cannabidiol.FDA label
- The same way with food each day
A high-fat meal raised cannabidiol levels about 4 to 5 times in the label's studies.
- The label asks for consistent timing relative to meals, so the amount absorbed stays steady.FDA label
- Only the syringes in the carton
The label says a household teaspoon or tablespoon is not an adequate measuring device.
- Each carton has two 1mL and two 5mL oral syringes and a bottle adapter.FDA label
- Feeding tubes
Epidiolex can go through silicone nasogastric or gastrostomy tubes, followed by a water flush.
- The label says not to use tubes made of PVC or polyurethane.FDA label
- The 12-week bottle limit
Use within 12 weeks of first opening the bottle, then discard the rest.
- Store the bottle upright at room temperature and never freeze it.FDA label
- Missed doses
The label and Medication Guide do not give a missed dose instruction for Epidiolex.
- The neurologist or pharmacist can say what to do, and the Jazz helpline can give general information.FDA label
- Never stop suddenly
The Medication Guide says not to stop Epidiolex without first talking to the doctor.
- The label lowers the dose gradually when treatment ends, because stopping suddenly can bring more seizures.FDA label
- Valproate and clobazam
With both valproate and clobazam, 30% of trial patients had ALT above 3 times normal, against 3% on neither.
- Sleepiness affected 46% of those taking clobazam, against 16% without it.
- The prescriber may adjust either medicine.FDA label
- Other medicines and supplements
Strong enzyme inducers such as rifampin can lower Epidiolex levels.
- Epidiolex raises everolimus levels and can change how clopidogrel works.
- Alcohol and other sedating medicines add to sleepiness.FDA label
- Drug tests
The label warns that Epidiolex can cause a positive drug screen for cannabis.FDA label
- Weight and blood counts
In the trials, 16% on Epidiolex lost at least 5% of their body weight, against 8% on placebo.
- Low red blood cell counts and a small rise in creatinine were also seen.FDA label
- Pregnancy
The label encourages enrolling in the Epidiolex Pregnancy Surveillance Program at 1-855-272-7158 and the North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs of liver problems
Loss of appetite, nausea or vomiting, fever, feeling unwell, unusual tiredness, yellow skin or eyes, itching, dark urine, or pain in the upper right belly.
- The Medication Guide says to call the doctor right away.FDA label
Sleepiness and low energy
Somnolence was among the most common side effects and was more frequent with clobazam.
- The label advises against driving or other dangerous activities until the effect is known.FDA label
Eating less or losing weight
Decreased appetite affected 22% at the higher trial dose, against 5% on placebo.
- The neurologist tracks weight over time.FDA label
Mood and behavior changes
New or worse depression, anxiety, irritability, aggression or thoughts of self-harm.
- The label says all seizure medicines carry this risk and asks families to report behaviors of concern right away.FDA label
Allergic reactions
Itching, skin redness or swelling such as of the face, lips or tongue.
- Some trial patients needed treatment for these.
- The label says to seek medical care right away and not to restart Epidiolex after a hypersensitivity reaction.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- Prior authorization pending or deniedCigna asks for age 1 or older and a neurologist. It also wants 2 other seizure medicines, or one of Fintepla, Diacomit or clobazam, tried or taken alongside. The office lists those medicines on the request. Cigna approves 1 year at a time.Cigna policy
- A copay you cannot payWith commercial insurance, eligible patients may pay as little as $0 per prescription through the JazzCares Copay Savings Program, with possible monthly or annual limits. It is not valid with Medicare, Medicaid or other government programs. Our help paying page lists charity funds.Copay program
- The pharmacy cannot reach youJazz says to answer calls from unfamiliar 1-800 or local numbers, because the specialty pharmacy calls to confirm insurance and delivery before shipping.How to get Epidiolex
Cigna prior authorization policy, May 1, 2026
- Dravet syndrome, patient 1 year of age or older
- Tried or currently taking at least 2 other seizure medicines, such as valproic acid, topiramate, clonazepam, levetiracetam or zonisamide
- Or tried or currently taking one of Fintepla (fenfluramine), Diacomit (stiripentol) or clobazam
- Prescribed by or in consultation with a neurologist
Approval length. Approved a year at a time. Renewal needs the patient to be responding, such as reduced seizure severity, frequency or duration, as judged by the prescriber.
This version took effect May 1, 2026 and cites the June 2025 label, before the June 2026 revision, which did not change dosing or the Dravet indication. Other plans set their own criteria and approval lengths. It is here as an example of what a plan asks for, not as a rule. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- JazzCares Copay Savings Program for commercial insurance, as little as $0 per prescription, with possible monthly or annual limits. No enrollment needed, since the pharmacy checks eligibility. Not valid with Medicare, Medicaid, VA, TRICARE, the Indian Health Service or other government programs Copay program
- A JazzCares Nurse Navigator for information and questions during treatment How to get Epidiolex
- Delivery from a specialty pharmacy that works with the family's insurance, with some able to ship to a local store for pickup How to get Epidiolex
Details as the drugmaker publishes them. Copay program
Five questions for the pharmacist or the support line
- How many milliliters is each dose, and should we use the 1mL or the 5mL syringe?
- When does this bottle reach 12 weeks after opening, and when should we reorder?
- My child takes valproate or clobazam. What should we watch for?
- Do any of my child's other medicines or supplements interact with Epidiolex?
- Can we give it through my child's feeding tube, and what kind of tube is it?
Questions people ask in the first weeks
What dose of Epidiolex is used for Dravet syndrome?
The label starts at 2.5mg/kg twice a day. After one week, it can rise to the maintenance dose of 5mg/kg twice a day. If more seizure control is needed, it can rise weekly by 2.5mg/kg twice a day, to a maximum of 10mg/kg twice a day.
How often are liver tests needed on Epidiolex?
The label asks for ALT, AST and total bilirubin before starting, then at 1, 3 and 6 months, and periodically after that. It also asks for a test within 1 month of a dose change or of adding a medicine that affects the liver.
Is Epidiolex the same as store-bought CBD?
No. Jazz describes Epidiolex as the first and only FDA-approved prescription cannabidiol, and its dose and warnings come from the clinical trials in its label. CBD products sold in stores are not FDA-approved to treat seizures.
Does Epidiolex have a boxed warning or a REMS?
No. The label has no boxed warning and Epidiolex has no REMS. Its main warnings cover liver enzyme increases, sleepiness, mood changes, allergic reactions and stopping too quickly.
How soon might Epidiolex reduce seizures?
In the label's Dravet trial, fewer convulsive seizures were seen within 4 weeks of starting. Median convulsive seizures fell 39% on Epidiolex against 13% on placebo. Each child responds differently, and the neurologist tracks progress.
What does Epidiolex cost with insurance?
Through the JazzCares Copay Savings Program, eligible commercially insured patients may pay as little as $0 per prescription. It excludes Medicare, Medicaid and other government programs. Call 1-833-426-4243 for details.
Free email alert
Hear when the Epidiolex label changes
One email the day the FDA revises the Epidiolex label, with what changed in plain words. No trial alerts, no newsletter.
Label changes for Epidiolex only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
Want the whole condition instead? Follow Dravet syndrome for new trials, FDA decisions and label changes for every treatment.
Sources
- EPIDIOLEX (cannabidiol) oral solution: prescribing information, Medication Guide and Instructions for Use, Jazz Pharmaceuticals, Inc., via DailyMed, May 29, 2026.
- The EPIDIOLEX® Copay Savings Program, Jazz Pharmaceuticals, November 10, 2026.
- Doctor Discussions and Financial Support | EPIDIOLEX® (cannabidiol), Jazz Pharmaceuticals, November 10, 2026.
- Drug Coverage Policy IP0410, Epidiolex (Antiseizure Medications, Epidiolex), Cigna, May 1, 2026.
- Drugs@FDA record for NDA 210365, EPIDIOLEX, via openFDA, FDA, November 10, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing neurologist. Found an error? Use the report link in the footer and it will be checked against the source.