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What is Wakix
PitolisantThe Generic name of this drug
Treatment SummaryPitolisant is a medication used to treat narcolepsy, a chronic neurological disorder that causes excessive daytime sleepiness and other symptoms such as sleep paralysis and hypnagogic hallucinations. Pitolisant works by blocking histamine receptors in the brain, which helps to keep people awake. In clinical trials, pitolisant was shown to reduce sleepiness in adult and adolescent narcolepsy patients. It is commonly known as Wakix, and was approved by the FDA in 2019 for excessive daytime sleepiness in adults associated with narcolepsy.
Wakixis the brand name
Wakix Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Wakix
Pitolisant
2019
2
Approved as Treatment by the FDA
Pitolisant, commonly known as Wakix, is approved by the FDA for 1 uses which include Narcolepsy .Narcolepsy
Effectiveness
How Wakix Affects PatientsPitolisant helps people with narcolepsy stay awake and alert during the day by increasing histamine levels in the brain. It has been shown to improve the level and duration of wakefulness, alertness, and attention, as well as reducing the frequency and severity of cataplexy. It is also thought to block hERG channels. In clinical studies, taking higher than the recommended dose was linked to a mild to moderate increase in the QTc interval (10-13 ms).
How Wakix works in the bodyPitolisant is a drug that helps people with narcolepsy stay awake. It works by blocking certain receptors in the brain that reduce the amount of histamine, a neurotransmitter responsible for wakefulness. Pitolisant binds to these receptors and prevents them from blocking histamine. This increases the amount of histamine in the brain, which helps people stay alert. Pitolisant also increases the levels of other neurotransmitters like acetylcholine, noradrenaline, and dopamine, which further aids in keeping people awake.
When to interrupt dosage
The advised measure of Wakix relies upon the diagnosed condition, including Narcolepsy Without Cataplexy, Excessive Daytime Sleepiness and Narcolepsy With Cataplexy. The magnitude of dosage shifts as detailed in the following table, depending on the method of delivery (e.g. Tablet, film coated - Oral or Tablet).Condition
Dosage
Administration
Narcolepsy
, 4.5 mg, 18.0 mg, 4.45 mg, 17.8 mg, 20.0 mg, 5.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
Narcolepsy Without Cataplexy
, 4.5 mg, 18.0 mg, 4.45 mg, 17.8 mg, 20.0 mg, 5.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
Narcolepsy With Cataplexy
, 4.5 mg, 18.0 mg, 4.45 mg, 17.8 mg, 20.0 mg, 5.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral
Warnings
Wakix ContraindicationsCondition
Risk Level
Notes
Severe Hepatic Impairment
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Pitolisant may interact with Pulse Frequency
Common Wakix Drug Interactions
Drug Name
Risk Level
Description
Alectinib
Major
The metabolism of Alectinib can be increased when combined with Pitolisant.
Bendamustine
Major
The metabolism of Bendamustine can be increased when combined with Pitolisant.
Capmatinib
Major
The serum concentration of Capmatinib can be decreased when it is combined with Pitolisant.
Dacarbazine
Major
The metabolism of Dacarbazine can be increased when combined with Pitolisant.
Entrectinib
Major
The metabolism of Entrectinib can be increased when combined with Pitolisant.
Wakix Toxicity & Overdose RiskSymptoms of taking too much pitolisant may include headache, insomnia, irritability, nausea, and stomach pain. If an overdose is suspected, seek immediate medical attention. Long-term studies in mice, rats, and monkeys showed no adverse effects at doses of 75, 30, and 12 mg/kg/day, respectively. Pitolisant has not been linked to any genetic or cancer-causing effects. In pregnant rabbits and rats, pitolisant caused sperm abnormalities and decreased fertility in male rats. It also decreased the number of live births and increased post-implantation loss in female rats. Additionally, there was a delay
Wakix Novel Uses: Which Conditions Have a Clinical Trial Featuring Wakix?
Currently, 13 active trials are exploring the potential of Wakix to ameliorate Narcolepsy, Excessive Daytime Sleepiness and Narcolepsy With Cataplexy.Condition
Clinical Trials
Trial Phases
Narcolepsy With Cataplexy
2 Actively Recruiting
Phase 2, Not Applicable
Narcolepsy Without Cataplexy
2 Actively Recruiting
Phase 2, Not Applicable
Narcolepsy
10 Actively Recruiting
Phase 2, Phase 3, Not Applicable, Phase 4, Phase 1
Wakix Reviews: What are patients saying about Wakix?
4.7Patient Review
4/6/2021 Helped me become more alert in the morning. I almost felt like my old self again; however, my appetite increased quite a bit which led to gaining 25lbs in just a few months. My doctor took me off the medication because of this.
4.7Patient Review
12/6/2019 Wakix has been effective in keeping me awake, however there is no long term data on its usage or potential side effects. I have experienced chest pain which may or may not be related to the drug.
2.3Patient Review
10/12/2021 I was really hoping this treatment would work, but unfortunately it just hasn't. I've been taking it for two months now with no relief, and even taking the full dose for three weeks has made no difference. I'm not sure why it isn't working, but sadly it looks like I'll have to keep searching for something else.
1Patient Review
7/12/2022 I would not recommend this drug to anyone. It is ineffective and dangerous. Save your money and time by avoiding it.
Patient Q&A Section about wakix
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.Is Wakix a controlled substance?
"Harmony Biosciences has announced that the US Food and Drug Administration (FDA) has approved Wakix (pitolisant) to treat excessive daytime sleepiness (EDS) in adults with narcolepsy. This makes Wakix the first treatment for the condition not categorised as a controlled substance by the US Drug Enforcement Administration."
Answered by AI
What is the drug class of Wakix?
"Wakix is a drug that prevents histamine from being produced in the brain. It is not fully understood how it does this."
Answered by AI
What is Wakix used for?
"The FDA has approved a new medication, WAKIX, for the treatment of narcolepsy. WAKIX is a once-daily tablet that increases histamine levels in the brain, and is the first FDA-approved treatment for narcolepsy that is not a controlled substance."
Answered by AI
Is Wakix a stimulant?
"B. WAKIX is not a stimulant, no.
C. WAKIX is not a stimulant, rather it is a non-stimulant.
D. WAKIX, though not a stimulant, has other benefits.
No, WAKIX is not a stimulant. It is a non-stimulant."
Answered by AI