Wakix

Narcolepsy, Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy

Treatment

2 FDA approvals

2 Active Studies for Wakix

Treatment for

Narcolepsy

What is Wakix

Pitolisant

The Generic name of this drug

Treatment Summary

Pitolisant 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.

Wakix

is the brand name

image of different drug pills on a surface

Wakix Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Wakix

Pitolisant

2019

Approved as Treatment by the FDA

Pitolisant, commonly known as Wakix, is approved by the FDA for 2 uses which include Sleepiness, Excessive Daytime and Narcolepsy .

Sleepiness, Excessive Daytime

Narcolepsy

Effectiveness

How Wakix Affects Patients

Pitolisant 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 body

Pitolisant 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 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 - Oral, Tablet

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 - Oral, Tablet

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 - Oral, Tablet

Warnings

Wakix Contraindications

Condition

Risk Level

Notes

Severe Hepatic Impairment

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Pitolisant may interact with Pulse Frequency

There are 20 known major drug interactions with Wakix.

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 Risk

Symptoms 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

1 Actively Recruiting

Not Applicable

Narcolepsy Without Cataplexy

1 Actively Recruiting

Not Applicable

Narcolepsy

2 Actively Recruiting

Not Applicable, Phase 1

Wakix Reviews: What are patients saying about Wakix?

4.7

Patient Review

4/6/2021

Wakix for Recurring Sleep Episodes During the Day

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.

4.7

Patient Review

12/6/2019

Wakix for Recurring Sleep Episodes During the Day

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.

2.3

Patient Review

10/12/2021

Wakix for Recurring Sleep Episodes During the Day

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.

Patient Review

7/12/2022

Wakix for Recurring Sleep Episodes During the Day

I would not recommend this drug to anyone. It is ineffective and dangerous. Save your money and time by avoiding it.

image of drug pills surrounding a glass of water symbolizing drug consumption

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