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cbd dosage for epilepsy

About CBD for Epilepsy

Cannabidiol (CBD), a chemical found in cannabis and hemp plants, has been used to treat epilepsy with varying levels of efficacy, according to research and anecdotal evidence. Here’s what you need to know about using CBD for epilepsy.

About epilepsy

Epilepsy is a chronic neurological disorder that causes recurrent seizures. Seizures are marked by abnormal electrical activity in the brain. There is no cure for epilepsy, but there are a few ways to manage it.

  • Cannabinoid: This is a type of chemical in cannabis and hemp plants. Dozens of cannabinoids, each with their own characteristics, are found in cannabis and hemp plants.
  • Tetrahydrocannabinol (THC): This is a cannabinoid in hemp and cannabis plants that can make one feel intoxicated.
  • Medical cannabis: Sometimes referred to as medical marijuana, this is cannabis recommended for medical purposes.

Recent research suggests that CBD can help people with epilepsy, although some people may experience side effects.

There is only one CBD-based epilepsy medication approved by the Food and Drug Administration (FDA): Epidiolex.

The FDA initially approved the use of Epidiolex to treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in people 2 and older. In 2020, the FDA approved Epidiolex for people 1 and older. It also approved of the use of Epidiolex to treat tuberous sclerosis complex, another rare seizure condition.

Since these seizure conditions typically affect children and teenagers, Epidiolex is usually prescribed for children with epilepsy.

But what exactly does it mean to have FDA approval? The FDA itself doesn’t test products. Instead, the product’s manufacturer conducts laboratory, animal, and human clinical testing. The FDA reviews these results. According to the FDA website, they grant an approval if they conclude that “the benefits of the product outweigh the known risks for the intended use.”

Randomized, double-blind, placebo-controlled studies are considered the “gold standard” of clinical trials because they reduce the chance of bias and include a control. Both of these studies were conducted on the effects of Epidiolex on Dravet syndrome and Lennox-Gastaut syndrome.

The studies suggested that Epidiolex reduces the frequency of seizures. However, they also noted there are potential side effects of Epidiolex.

Although CBD is the basis of Epidiolex, using store-bought CBD is not exactly the same as using Epidiolex. Because Epidiolex is a pharmaceutical product, it’s held to higher manufacturing standards than commercial CBD. Commercial CBD isn’t regulated by the FDA.

One recent study compared the effects of artisanal, or store-bought, CBD with that of pharmaceutical-grade CBD on people with epilepsy, and it highlighted the potential risks with opting for store-bought CBD over Epidiolex.

Those who took artisanal CBD had a 70 percent increase in seizures during the study period, while those taking prescription CBD had a 39 percent reduction in seizures.

It’s important to note that artisanal CBD can have varying levels of THC and may not undergo testing, which may have contributed to the increase in seizure activity.

This study had its limitations. It was a retrospective study — meaning it involved looking back at a patient’s history instead of following it over time. It was also a small study, with 31 subjects and only 9 taking artisanal CBD.

Here’s what to know about using CBD for epilepsy. From research, what FDA-approval means, and CBD popping up in stores.

cannabidiol (Rx)

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Dosing & Uses

Dosage Forms & Strengths

solution, oral
  • 100mg/mL

Seizures

Indicated for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC)

LGS or DS
  • 2.5 mg/kg PO BID initially; after 1 week, may increase to maintenance dose of 5 mg/kg BID
  • If 5 mg/kg BID tolerated and further seizure reduction required, patient may benefit from a dosage increase up to a maximum recommended maintenance dosage of 10 mg/kg BID (ie, 20 mg/kg/day)
  • Increasing to 10 mg/kg BID may be achieved by increased weekly increments of 2.5 mg/kg BID, as tolerated
  • If a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased no more frequently than every other day
  • Administration of the 20-mg/kg/day dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions
  • Starting dose: 2.5 mg/kg PO BID
  • Increase dose in weekly increments of 2.5 mg/kg BID as tolerated, to recommended maintenance dose of 12.5 mg/kg BID
  • If a more rapid titration is warranted, the dosage may be increased no more frequently than every other day
  • Effectiveness of doses 3 x ULN in presence of elevated bilirubin without alternative explanation are important predictors of severe liver injury and should be evaluated before initiating cannabidiol

Hepatitis (Orphan)

Orphan designation for treatment of autoimmune hepatitis

Orphan sponsor
  • Revive Therapeutics Ltd; 5 Director Court, Suite 105; Vaughan, Ontario; Canada

Huntington Disease (Orphan)

Orphan designation for delta-9-THC and cannabidiol for treatment of Huntington disease

Sponsor
  • MMJ International Holdings; 1895 Preston White Drive, Suite 101; Reston, Virginia 20191

Dosage Forms & Strengths

solution, oral
  • 100mg/mL

Seizures

Indicated for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients aged ≥1 yr

Age ≥1 year
LGS or DS
  • 2.5 mg/kg PO BID initially; after 1 week, may increase to maintenance dose of 5 mg/kg BID
  • If 5 mg/kg BID tolerated and further seizure reduction required, patient may benefit from a dosage increase up to a maximum recommended maintenance dosage of 10 mg/kg BID (ie, 20 mg/kg/day)
  • Increasing to 10 mg/kg BID may be achieved by increased weekly increments of 2.5 mg/kg BID, as tolerated
  • If a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased no more frequently than every other day
  • Administration of the 20-mg/kg/day dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions
    • Starting dose: 2.5 mg/kg PO BID
    • Increase dose in weekly increments of 2.5 mg/kg BID as tolerated, to recommended maintenance dose of 12.5 mg/kg BID
    • If a more rapid titration is warranted, the dosage may be increased no more frequently than every other day
    • Effectiveness of doses 3 x ULN in presence of elevated bilirubin without alternative explanation are important predictors of severe liver injury and should be evaluated before initiating cannabidiol

    Absence Epilepsy (Orphan)

    Orphan designation for treatment of childhood absence epilepsy

    Orphan sponsor
    • Insys Development Company, Inc; 1333 South Spectrum Blvd, Suite 100; Chandler, Arizona 85286

    Clinical trials did not include any patients aged >55 yr to determine whether or not they respond differently from younger patients

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

    Interactions

    Interaction Checker
    Contraindicated
    Serious – Use Alternative
    Significant – Monitor Closely
    Minor

    Adverse Effects

    >10% (LGS or DS)

    Infections, all (40-41%)

    Infection, other (21-25%)

    Decreased appetite (16-22%)

    Transaminases elevated (8-16%)

    Fatigue, malaise, asthenia (11-12%)

    Infection, viral (7-11%)

    >10% (TSC)

    Elevated transaminases (25%)

    Decreased appetite (20%)

    1-10% (LGS or DS)

    Irritability, agitation (5-9%)

    Anger, aggression (3-5%)

    Decreased weight (3-5%)

    Hypoxia, respiratory failure (3%)

    Infection, fungal (1-3%)

    1-10% (TSC)

    Gait disturbance (9%)

    Ear infection (8%)

    Decreased weight (7%)

    Decreased platelet count (5%)

    Increased eosinophil count (5%)

    Fatigue, malaise, asthenia (5%)

    Urinary tract infection (5%)

    Warnings

    Contraindications

    Hypersensitivity to cannabidiol or any of the product ingredients

    Cautions

    Can cause somnolence and sedation that is dose-related; clobazam and other CNS depressants, including alcohol, may potentiate this adverse effect; monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on drug to gauge whether it adversely affects their ability to safely drive or operate machinery

    Antiepileptic drugs (AEDs), including cannabidiol, increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior

    May cause hypersensitivity reactions (eg, pruritus, erythema, angioedema)

    As with other AEDs, cannabidiol should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus; if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered

    Therapy can cause weight loss, which may be dose-related

    A decrease in hemoglobin and hematocrit reported with no effect on red blood indices

    Elevation of serum creatinine reported within 2 weeks of initiating therapy that was reversible in healthy adults; mechanism not determined

    Medscape – Seizure dosing for Epidiolex (cannabidiol), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information.