Epidiolex For Schizophrenia - Does It Really Work?
Cannabis has more than 100 different cannabinoids, making it a very diverse plant.
Several studies back up the conclusion that using cannabis is linked to psychosis and schizophrenia.
Epidiolex for schizophrenia is a name-brand antipsychotic medication.
The Food and Drug Administration has given it permission to treat seizures caused by Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex (TSC).
Epidiolex has the active ingredient cannabidiol (CBD).
A liquid solution is provided for oral administration.
Epidiolex can be used safely by both adults and children over the age of one.
Epidiolex was authorized by the Food and Drug Administration (FDA) in June 2018.
It was the first medication authorized to treat Dravet syndrome patients' seizures.
Epidiolex was then approved to treat Lennox-Gastaut syndrome patients' seizures as well.
Epidiolex was then authorized in 2020 to treat seizures in TSC patients.
Epidiolex includes cannabis-derived cannabidiol (CBD) (also called marijuana).
The first cannabis-based medication to receive FDA approval is called Epidiolex.
You might be concerned about whether Epidiolex will have the same effects on you or your child as cannabis.
Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the two primary substances found in cannabis.
The effects of these substances on the body vary.
THC may give you a "high" or euphoric feeling. However, CBD doesn't give you such feelings.
Epidiolex solely has CBD in it. You won't get "high" from it because it doesn't contain any THC.
2018 saw the first time Epidiolex was authorized for usage, and it was a controlled substance.
Epidiolex is no longer a controlled substance as of April 2020, nonetheless.
A drug that can be abused or lead to dependence is referred to as a controlled substance.
Additionally, the federal government controls how it is used.
At the time of its approval, Epidiolex was categorized as a schedule V prescription medicine.
Higher-classified substances (such as those in schedule V) are less likely to be abused than drugs in lower classes (such as schedule I).
When a substance is misused, it is utilized differently than how it was intended.
Federal and state laws limit the number of refills that can be given for prescriptions for drugs that are illegal.
The laws also place limitations on the exchange of prescriptions between pharmacies.
Epidiolex is easier for doctors to recommend now that the FDA has taken it off its list of drugs that can't be used by everyone.
Also, the change will make it easier for people to switch doctors and get their Epidiolex prescriptions filled.
Epidiolex's negative effects might range from minor to severe.
Some of the most significant negative effects associated with using Epidiolex are listed below.
Not all potential adverse effects are covered in this list.
The following are some of Epidiolex's more frequent side effects:
- Infections (such as viral or fungal infections)
- Insomnia (trouble sleeping)
- Skin rash
- Loss of appetite
- Malaise (generally not feeling well)
- Feeling weak
- Fatigue (lack of energy)
If any of these side effects last or get worse, talk to your doctor or pharmacist.
Although they are uncommon, serious adverse effects from Epidiolex can happen.
If you experience severe adverse effects, believe you are experiencing a medical emergency, or believe your symptoms are life-threatening, call your doctor immediately.
The following are examples of serious side effects, which are explained in more detail below under "Side effect details":
- Suicidal thoughts or behavior
- Severe allergic reaction
- Sedation (sleepiness, loss of coordination, and trouble thinking clearly)
- Liver problems
You might be curious about the frequency of particular adverse effects with this medication.
Here are some specific side effects that this medication may have.
Like with most medications, taking Epidiolex can cause allergic reactions in some people.
A minor allergic reaction may cause the following symptoms:
- Flushing (warmth and redness in your skin)
- Skin rash
Although uncommon, a more serious allergic reaction is possible.
A strong allergic reaction may cause the following symptoms:
- Trouble breathing
- Angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
If you or your child experience a severe allergic reaction to Epidiolex, contact your doctor immediately.
Users frequently experienced drowsiness as a side effect during clinical trials.
Up to 25% of users reported experiencing particularly restless sleep.
A placebo treatment, which contains no actual medication, has a 9% somnolence rate.
During clinical trials, up to 12% of people who took Epidiolex felt tired or had low energy.
Additionally, 4% of those taking a placebo reported feeling tired.
Additionally, throughout clinical investigations, 3% to 6% of Epidiolex users reported feeling drowsy.
1% of those taking a placebo reported feeling sleepy. Sedation signs can include:
- Being unable to safely operate equipment or machinery, such as a car
- Trouble thinking clearly
- Loss of coordination
People taking greater dosage of Epidiolex generally experience If you are taking Epidiolex, don't drive or use machinery until you know how it will affect you. Those taking lower doses are more likely to experience these side effects than those taking higher doses.
Consult your doctor if you or your kid has any of these side effects after taking Epidiolex.
They might need to adjust your Epidiolex dosage or have you try an alternative drug.
If you are taking Epidiolex, don't drive or use machinery until you know how it will affect you.
In clinical investigations, between 5% and 11% of Epidiolex users experienced specific sleep issues.
And 4% of people who took a placebo, which is a medicine with no active ingredient, had trouble sleeping.
The reported sleep issues included:
- Sleep disruption
- Poor quality of sleep
- Insomnia (trouble falling asleep or staying asleep)
People receiving lower dosages of Epidiolex experienced sleep issues more frequently than those taking greater doses of the medication.
Consult your doctor for advice on how to get a better night's sleep if you or your child struggles to sleep while taking Epidiolex.
In clinical studies, up to 31% of those who took Epidiolex experienced diarrhea.
People who took bigger doses of the medicine had diarrhea more often than those who took smaller doses.
On the other hand, between 9 and 25% of people who took a placebo (a fake medicine with no active ingredient) got diarrhea.
Consult your doctor if you or your child has diarrhea while taking Epidiolex.
They can offer suggestions on how to lessen this adverse effect.
Users have reported experiencing liver damage.
Between 8% and 25% of participants in clinical tests who were taking the medication had elevated liver enzyme levels.
High levels of liver enzymes in the blood may indicate a liver issue.
On the other hand, up to 3% of people who took a placebo (a medicine with no active ingredient) had higher levels of liver enzymes.
Among the signs of liver issues are:
- Dark-colored urine
- Jaundice (yellowing of your skin and the whites of your eyes)
- Loss of appetite
- Pain in your upper abdomen
According to clinical research, Epidiolex users who took greater doses experienced liver issues more frequently than those who took lesser doses of the medication.
During clinical trials, liver damage was one of the most common reasons why people stopped taking Epidiolex.
If you have liver disease, there is an increased risk of liver damage when using Epidiolex.
Before beginning Epidiolex, be sure to discuss your medical history with your doctor.
Your doctor will examine your liver function before you start taking Epidiolex.
This enables them to check that your liver is in good enough shape for you to take this medication.
Your doctor may continue to perform lab tests to check on your liver function while you are taking Epidiolex.
If liver damage happens while you are being treated, you may need to stop taking the medicine.
If you experience any liver-related symptoms while taking Epidiolex, inform your doctor right away.
During Epidiolex clinical investigations, weight loss was noted.
People who took higher doses of Epidiolex lost more weight than those who took lower doses.
After nearly four months of therapy,
- 8% of people taking a placebo (treatment with no active drug) each 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.
- 18% of people taking 20 mg/kg of Epidiolex per day lost at least 5% of their body weight.
- 31% of people taking 25 mg per kilogram (mg/kg) of Epidiolex per day lost at least 5% of their body weight.
Epidiolex may cause weight loss as a side effect.
During clinical tests, 16% to 22% of people who took Epidiolex said they didn't want to eat as much.
Epidiolex users may experience weight loss due to an absence of appetite.
Ask your doctor about strategies to help you or your kid maintain a healthy weight if you're worried about weight loss while taking Epidiolex.
Suicidal ideas and actions may be made more likely.
This risk is further raised by additional anti-epileptic drugs used to treat epilepsy.
The FDA examined a number of studies conducted on people taking anti-epileptic medications.
There were 11 different medicines examined.
According to this investigation, epilepsy patients were more likely to have suicidal thoughts and actions.
People who weren't taking anti-epilepsy medications had a risk that was 80% higher than those who were.
After just one week of using the medicine, the danger increased.
Before Epidiolex was made accessible, these studies were conducted.
How frequently Epidiolex users engage in suicidal conduct or ideation is unknown.
Your doctor will keep a careful eye on you or your child while you are taking Epidiolex for any indications of new or worsening sadness or strange mood swings.
If you observe these symptoms in yourself or your kid, or if you have thoughts of harming yourself, speak with your doctor immediately.
Epidiolexis' beginning dose is 2.5 mg/kg administered twice daily (5 mg/kg/day).
The dosage can be raised to a maintenance dose of 5 mg/kg twice daily (10 mg/kg/day) after one week.
Your doctor will recommend a different Epidiolex dosage depending on a number of variables. These consist of:
- Other medications you or your child is taking
- Your or your child’s liver function
- The severity of the condition that Epidiolex is being used to treat
- The condition related to your or your child’s seizures
- Your or your child’s weight
Normally, your doctor would start you or your child on a low dosage and gradually increase it until it is effective.
In the end, they'll recommend the smallest dose that nevertheless produces the intended result.
Schizophrenia cannot currently be treated with epidiolex.
In a number of short studies, CBD helped some people with schizophrenia symptoms.
Other trials, however, have not demonstrated an improvement in symptoms following CBD therapy.
The safety or efficacy of epidiolex in treating schizophrenia has not been established.
Use Epidiolex only as prescribed by your physician.
The treatment of seizures linked to the rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age or older, has been approved by the U.S. Food and Drug Administration.
Critics are outraged by the $32,500 list price of Epidiolex, the first cannabis medication to hit the market.
It's official - the first CBD product with FDA approval is now available.
This morning, GW Pharmaceuticals announced that Epidiolex, a cannabinoid that has been approved to treat two very rare types of epilepsy, can now only be bought with a prescription.
Other CBD, "hemp," and medical marijuana products may include trace quantities of THC, but Epidiolex, a pharmaceutical-grade cannabidiol oil product made by Greenwich, does not.
Some of the most common side effects of Epidiolex are drowsiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, trouble sleeping, infections, and infections.
Epidiolex was a schedule five (V) controlled substance when it was approved in 2018.
But as of April 2020, the medicine is no longer considered to be a banned substance.
There were no instances of abuse or dependence in clinical investigations.
All anti-epilepsy drugs should not be stopped all at once, because doing so could cause more seizures and status epilepticus.
It is advised to titrate gradually.