Table of Contents
What is pitolisant used for?
Pitolisant is used to treat cataplexy (weak or paralyzed muscles) or excessive daytime sleepiness (EDS) in patients with narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.
What type of drug is pitolisant?
Pitolisant is in a class of medications called H3 blockers. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.
Is pitolisant a stimulant?
Drugs such as pitolisant, which block histamine H3 autoreceptors, constitute a newly identified class of stimulants because they increase brain histamine and enhance wakefulness in animal and human adult narcolepsy.
Who makes pitolisant?
Please see the Full Prescribing Information for WAKIX for more information. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA.
Is Wakix a stimulant?
A. No, WAKIX is not a stimulant.
Does Wakix cause weight gain?
In clinical trials, 3% of people who took Wakix had a decreased appetite. No one who took a placebo reported this side effect. Having a decreased appetite can cause you to eat less, which can lead to weight loss. If you’re concerned about your appetite decreasing while taking Wakix, talk with your doctor.
Where is pitolisant approved?
Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults.
Is pitolisant a controlled substance?
Pitolisant was demonstrated to have minimal risk of abuse in preclinical and clinical studies, and is the only anti-narcoleptic drug not scheduled as a controlled substance in the USA.
Where can I buy Wakix?
WAKIX is available through a select group of specialty pharmacies….To get your patients started
- Complete the WAKIX Prescription Referral Form.
- Fax the completed form to WAKIX for You at 1-855-635-8520.
Is there a generic for Wakix?
Wakix is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication.
Who should not take Wakix?
The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age. WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment.
Is Wakix expensive?
WakixR is its trade name in the USA. Like sodium oxybate, it is very expensive. Most medicines for daytime sleepiness are now generic and cost about $1 a pill. If your insurance charges you more, you can always find it at that price on GoodRx.com.
Is pitolisant FDA approved for OSA?
It was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of sleepiness due to narcolepsy and has been available in the United States since November 2019.
Is Wakix addictive?
Wakix binds to histamine 3 (H3) receptors to regulate the production and release of histamine in the brain, but its exact mechanism is not fully known. Substances classified by the DEA as controlled substances typically have some level of abuse potential and addiction.
How expensive is Wakix?
The cost for Wakix oral tablet 4.45 mg is around $3,592 for a supply of 30 tablets, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
How do you get prescribed Wakix?
Prescribing WAKIX
- Complete the WAKIX Prescription Referral Form. The diagnosis (ICD-10) codes for narcolepsy are included on the prescription referral form: G47.
- Fax the completed form to WAKIX for You at 1-855-635-8520.
- WAKIX for You will contact your patient directly to help him or her get started with WAKIX.
How much is Wakix?
The cost for Wakix oral tablet 4.45 mg is around $3,592 for a supply of 30 tablets, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans. Wakix is available as a brand name drug only, a generic version is not yet available.
How much does Wakix cost per month?
Wakix Coupon & Prices – Cost $49 per month.
What is the brand name of Pitolisant?
Pitolisant, sold under the brand name Wakix among others, is a medication for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. It is a histamine 3 (H 3) receptor antagonist/ inverse agonist. It represents the first commercially available medication in its class.
What is Pitolisant used to treat?
Pitolisant is used in adults for the treatment of excessive daytime sleepiness in people with narcolepsy, with or without cataplexy. Narcolepsy is a sleep problem that is characterized by an irresistible urge to sleep and disturbed nighttime sleep, while cataplexy refers to attacks of severe muscle weakness that cause a person to collapse.
Is Pitolisant an orphan drug?
The European Medicines Agency (EMA) approved the use of pitolisant ( Wakix, Bioprojet Pharma) for treatment of narcolepsy with or without cataplexy. The FDA granted it orphan drug status. Such designation provides the pharmaceutical companies with incentives such as lowered fees for scientific advice and access to patients.
What is the mechanism of action of intramuscular Pitolisant?
Pitolisant is a drug designed to promote wakefulness and so reduce excessive daytime sleepiness (EDS), whilst also resulting in a significant reduction in cataplexy. This dual action may be because it works by increasing the activity of histamine neurons in the brain, a mechanism that is completely different to most classic stimulants.