FDA approved Epidiolex (cannabidiol) for Seizures Associated with LGS, DS, or TSCFDA approved new cannabis-based drug for severe epilepsy in children.

FDA From the archive Source published June 25, 2018 Summary added June 9, 2026 DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Monitor liver enzymes before and during Epidiolex therapy; titrate dose gradually based on indication and hepatic function.

The FDA has approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients aged 1 year and older. This is the first FDA-approved drug containing a purified drug substance derived from cannabis. The approval provides a new option for patients with these often treatment-resistant epilepsy syndromes. Clinicians should note that baseline and periodic monitoring of serum transaminases and bilirubin is required due to risk of hepatocellular injury. Dosing is weight-based and requires gradual titration to a maintenance dose, with adjustments for hepatic impairment.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

The precise mechanism by which cannabidiol exerts its anticonvulsant effect in humans is unknown. Cannabidiol does not appear to exert its anticonvulsant effects through interaction with cannabinoid receptors.

Indication & Patient Population

Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.

Dosing & Administration

Prior to initiation, obtain serum transaminases (ALT and AST) and total bilirubin. For LGS or DS: start at 2.5 mg/kg twice daily (5 mg/kg/day); after one week increase to 5 mg/kg twice daily (10 mg/kg/day); may further increase to max 10 mg/kg twice daily (20 mg/kg/day) based on response and tolerability. For TSC: start at 2.5 mg/kg twice daily; increase weekly by 2.5 mg/kg twice daily to recommended maintenance of 12.5 mg/kg twice daily (25 mg/kg/day). Administer consistently with respect to meals. Use calibrated oral syringe. For hepatic impairment: adjust starting and maintenance doses per Child-Pugh classification (see label Table 1).

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Risk of hepatocellular injury: monitor transaminases and bilirubin at baseline and periodically. Discontinue if significant liver injury occurs. Avoid abrupt discontinuation to minimize risk of increased seizure frequency and status epilepticus. Somnolence and sedation: caution with CNS depressants. Suicidal behavior and ideation: monitor for worsening depression or suicidal thoughts.

Place in Therapy

Epidiolex offers a novel treatment option for seizures associated with LGS, DS, and TSC in patients aged 1 year and older. It requires baseline and periodic liver monitoring and gradual dose titration. Its role relative to other antiseizure medications is not specified in the label.

The FDA has approved a new drug called Epidiolex (cannabidiol) oral solution. It is the first FDA-approved medicine made from a purified form of cannabis. The drug is used to treat seizures in patients aged 1 year and older who have one of three rare and severe forms of epilepsy: Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. These conditions often do not respond well to other treatments.

Epidiolex is not a cure, but it offers a new option for patients who have not had success with other seizure medicines. The approval was based on studies showing that the drug reduced the frequency of seizures in these patients. Because the drug can cause liver injury, doctors will need to monitor liver function with blood tests before and during treatment.

Patients and families should talk to their doctor to see if Epidiolex might be right for them. This drug is not approved for other types of epilepsy or for general use. It is a prescription medicine that requires careful dosing and monitoring. Always follow your doctor's guidance.

What this means for you:

Epidiolex is a new cannabis-based drug for certain severe epilepsies, but it requires doctor supervision and liver monitoring.

Study Details

Study typeFda approval

PublishedJun 2018

View Original Abstract ↓

1 INDICATIONS AND USAGE EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older ( 1 )

FDA approved Epidiolex (cannabidiol) for Seizures Associated with LGS, DS, or TSCFDA approved new cannabis-based drug for severe epilepsy in children.

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FDA approved Epidiolex (cannabidiol) for Seizures Associated with LGS, DS, or TSCFDA approved new cannabis-based drug for severe epilepsy in children.

Study Details

Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke

Tenecteplase improves stroke recovery but increases bleeding risk in late treatment window

Clinical research that matters. Delivered to your inbox.

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