Neurology
Dravet syndrome: 2 drugs compared for prescribers
Epidiolex, Fintepla side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for Dravet syndrome. One other FDA-approved medicine for Dravet syndrome has no prescribing guide here yet and is listed below.
When to suspect Dravet syndrome and what to test →The 2 Dravet syndrome prescribing guides
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The 2 drugs with a prescribing guide, side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Epidiolexcannabidiol | Finteplafenfluramine | |
|---|---|---|
| Label dated | May 29, 2026 | October 22, 2026 |
| Starting dose | 2.5mg/kg twice daily (5mg/kg/day). | 0.1mg/kg twice daily, with or without food. For Dravet syndrome the label calls this the initial starting and maintenance dosage. |
| Dispensing gate | No REMS: baseline ALT, AST and total bilirubin, then prior authorization and a specialty pharmacy that works with the plan | Fintepla REMS: certified prescriber and pharmacy, enrolled patient, baseline echocardiogram reported on the Patient Status Form, then prior authorization |
| Required monitoring | ALT, AST and total bilirubin at baseline, 1, 3 and 6 months, then periodically and within 1 month of dose or interacting-drug changes; somnolence; weight; mood and suicidality | Echocardiogram at baseline, every 6 months and once 3 to 6 months after the last dose, each on a REMS Patient Status Form; blood pressure; weight and growth; somnolence; mood and suicidality |
| Example PA threshold | Cigna example: age 1 or older, neurologist, at least 2 other ASMs or one of Fintepla, Diacomit or clobazam tried or concomitant, 1-year approval | Cigna example: age 2 or older, neurologist, at least 2 other ASMs or one of clobazam, Epidiolex or Diacomit tried or concomitant, 1-year approval |
| Support line | JazzCares: 1-833-426-4243, weekdays 8 AM to 8 PM ET; copay as little as $0 for commercial plans with no enrollment needed; Nurse Navigator | UCB ONWARD: Clinical Nurse Educators 1-833-463-7547, Care Coordinators 1-888-964-3649 for enrolled families, copay as little as $0 and no more than $25 per refill for commercial plans, uninsured and echo copay programs, At-Home Echo Program |
- Label dated
- May 29, 2026
- Starting dose
- 2.5mg/kg twice daily (5mg/kg/day).
- Dispensing gate
- No REMS: baseline ALT, AST and total bilirubin, then prior authorization and a specialty pharmacy that works with the plan
- Required monitoring
- ALT, AST and total bilirubin at baseline, 1, 3 and 6 months, then periodically and within 1 month of dose or interacting-drug changes; somnolence; weight; mood and suicidality
- Example PA threshold
- Cigna example: age 1 or older, neurologist, at least 2 other ASMs or one of Fintepla, Diacomit or clobazam tried or concomitant, 1-year approval
- Support line
- JazzCares: 1-833-426-4243, weekdays 8 AM to 8 PM ET; copay as little as $0 for commercial plans with no enrollment needed; Nurse Navigator
- Label dated
- October 22, 2026
- Starting dose
- 0.1mg/kg twice daily, with or without food. For Dravet syndrome the label calls this the initial starting and maintenance dosage.
- Dispensing gate
- Fintepla REMS: certified prescriber and pharmacy, enrolled patient, baseline echocardiogram reported on the Patient Status Form, then prior authorization
- Required monitoring
- Echocardiogram at baseline, every 6 months and once 3 to 6 months after the last dose, each on a REMS Patient Status Form; blood pressure; weight and growth; somnolence; mood and suicidality
- Example PA threshold
- Cigna example: age 2 or older, neurologist, at least 2 other ASMs or one of clobazam, Epidiolex or Diacomit tried or concomitant, 1-year approval
- Support line
- UCB ONWARD: Clinical Nurse Educators 1-833-463-7547, Care Coordinators 1-888-964-3649 for enrolled families, copay as little as $0 and no more than $25 per refill for commercial plans, uninsured and echo copay programs, At-Home Echo Program
Other FDA-approved medicines for Dravet syndrome
These have no Trial Friend prescribing guide yet, so they are not in the comparison above. Some are approved for a different form or use of the condition than the guides above, and each drug page gives its indication. The list comes from Trial Friend's audited list of FDA labels that name this condition, built October 21, 2026.
- DiacomitStiripentolBiocodex
FDA decisions for Dravet syndrome
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- June 2026Epidiolex. 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
- October 2025Fintepla. The dosing section gained a formula for turning the weight-based dose into milliliters. The syringe cleaning steps in the Instructions for Use were updated, and the pregnancy section added general information on epilepsy risks in pregnancy. FDA letter
- June 2025Epidiolex. The drug interaction section was updated with results from studies of several liver enzymes. Drugs@FDA record
- April 2025Fintepla. The FDA approved revisions to the boxed warning and the heart valve and lung pressure warning, also reflected in the Medication Guide. The current text says cases have been reported since approval, although none occurred in trials of up to 3 years. FDA letter
- March 2024Epidiolex. The pregnancy section added the Epidiolex Pregnancy Surveillance Program, and the liver injury warning was revised. Drugs@FDA record
- December 2023Fintepla. Aggression was added to the list of side effects reported since approval. FDA letter
- September 2023Fintepla. The label switched to UCB's name and address after UCB acquired Zogenix. It also dropped the controlled substance listing, because fenfluramine was removed from federal drug schedules in December 2022. FDA letter
- January 2023Fintepla. Dose limits for people with mild, moderate or severe liver impairment were added, based on a study the FDA had required. FDA letter
Open trials
Questions prescribers ask about Dravet syndrome
Which Dravet syndrome drugs require a REMS?
This answer covers Epidiolex and Fintepla, the drugs with a prescribing guide here, and not the 1 other approved medicine listed on this page. None of the 2 Dravet syndrome drugs on this page has a REMS: Epidiolex and Fintepla. Each prescribing guide lists what does gate the first fill.
What monitoring do Dravet syndrome drugs require?
This answer covers Epidiolex and Fintepla, the drugs with a prescribing guide here, and not the 1 other approved medicine listed on this page. Epidiolex: ALT, AST and total bilirubin at baseline, 1, 3 and 6 months, then periodically and within 1 month of dose or interacting-drug changes; somnolence; weight; mood and suicidality. Fintepla: Echocardiogram at baseline, every 6 months and once 3 to 6 months after the last dose, each on a REMS Patient Status Form; blood pressure; weight and growth; somnolence; mood and suicidality.
What do insurers require before covering Epidiolex and Fintepla?
Each answer below is one public insurer policy, an example rather than every plan. Epidiolex: Cigna example: age 1 or older, neurologist, at least 2 other ASMs or one of Fintepla, Diacomit or clobazam tried or concomitant, 1-year approval. Fintepla: Cigna example: age 2 or older, neurologist, at least 2 other ASMs or one of clobazam, Epidiolex or Diacomit tried or concomitant, 1-year approval.
Which support programs start Dravet syndrome patients on therapy?
This answer covers Epidiolex and Fintepla, the drugs with a prescribing guide here, and not the 1 other approved medicine listed on this page. Epidiolex: JazzCares: 1-833-426-4243, weekdays 8 AM to 8 PM ET; copay as little as $0 for commercial plans with no enrollment needed; Nurse Navigator. Fintepla: UCB ONWARD: Clinical Nurse Educators 1-833-463-7547, Care Coordinators 1-888-964-3649 for enrolled families, copay as little as $0 and no more than $25 per refill for commercial plans, uninsured and echo copay programs, At-Home Echo Program.
A reference for licensed professionals, checked on November 10, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Dravet syndrome page and the first 90 days pages for Epidiolex, Fintepla.