Wakix (pitolisant)
An approved treatment for Narcolepsy Type 1.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Pitolisant wherever you encounter it, plus the key facts at a glance.
- Generic name
- Pitolisant
- Brand name
- Wakix
- Development code
- BF2.649
- Drug class
- Histamine-3 (H3) receptor antagonist/inverse agonist
- Manufacturer
- Harmony Biosciences
- How it's taken
- Tablet by mouth once a day on waking
A once-daily morning tablet for excessive daytime sleepiness or cataplexy in people 6 years and older with narcolepsy.
The FDA approved it for adult daytime sleepiness in August 2019 and added adult cataplexy in October 2020, daytime sleepiness in children 6 and older in June 2024 and cataplexy in children 6 and older in February 2026. Unlike the oxybate medicines and stimulants used in narcolepsy, Wakix is not a controlled substance.
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Where Pitolisant fits
Wakix (pitolisant) is a once-daily morning tablet for daytime sleepiness or cataplexy in people with narcolepsy aged 6 and older, and it is the narcolepsy medicine that works through histamine.
- Narcolepsy type 1 is also treated with wake-promoting drugs such as modafinil, stimulants, the nighttime oxybate medicines Xyrem, Xywav and Lumryz, and since August 2026 Orzeyful, which acts on orexin receptors.
- Wakix is not a controlled substance, while the oxybates and stimulants are.
- The label reports the Wakix trials against placebo only, though 2 adult trials also had a modafinil group, so the label does not show whether Wakix works better or worse than these other medicines.
- A question to bring to a sleep specialist is whether a CYP2D6 test, heart rhythm checks or a change in birth control are needed before starting.
How Pitolisant works
Narcolepsy type 1 is caused by the loss of brain cells that make orexin (also called hypocretin), a chemical messenger that keeps people awake and stabilizes muscle tone, which leads to overwhelming daytime sleepiness and cataplexy (sudden muscle weakness set off by strong emotions such as laughter). Histamine is another wake-promoting brain chemical, and the H3 receptor acts as a brake on how much of it nerve cells release.
Pitolisant blocks that receptor, which is thought to raise histamine activity in the brain and promote wakefulness; the label says its exact mechanism in narcolepsy is unclear[1].
Side effects and safety
- QT prolongation. Pitolisant can lengthen the QT interval on an ECG. The label says to avoid it with other QT-prolonging drugs and in people with heart rhythm problems, slow heart rate with symptoms, low potassium or magnesium, or congenital long QT. QT is checked in people with liver or kidney impairment.
- Hormonal birth control may work less well. Pitolisant can lower levels of hormonal contraceptives such as ethinyl estradiol. The label advises a non-hormonal method during treatment and for at least 21 days after the last dose.
- Allergic reactions. Anaphylaxis has been reported after approval, and a known allergy to pitolisant is a reason not to use it.
- The label suggests considering a test for CYP2D6 metabolizer status before starting
- QT checks in people with liver or kidney impairment
- Tell your doctor about all medicines, especially antihistamines that cause drowsiness, QT-prolonging drugs and medicines that change CYP2D6 or CYP3A4
- Pregnancy exposure registry at 1-800-833-7460
Wakix has no boxed warning. In 3 placebo-controlled adult trials, the side effects seen in at least 5% of people and at least twice as often as on placebo were insomnia (6% against 2%), nausea (6% against 3%) and anxiety (5% against 1%). Headache was the most frequent side effect overall (18% against 15%), and others included upper respiratory infection, musculoskeletal pain, faster heart rate, hallucinations, irritability, abdominal pain and decreased appetite.
Side effects led 3.9% of adults to stop, against 3.5% on placebo. In children 6 and older, the most common were headache (19%) and insomnia (7%). The label's 1 warning is QT prolongation, a change in the heart's electrical rhythm, so the label says to avoid it with other QT-prolonging drugs and in people with a history of heart rhythm problems, slow heart rate with symptoms, low potassium or magnesium, or a congenital long QT.
It is not allowed in severe liver impairment or with a known allergy to pitolisant, and anaphylaxis has been reported after approval. Pitolisant can make hormonal birth control less effective during treatment and for 21 days after stopping[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Pitolisant
Taken by mouth once a day in the morning on waking; the label reports that a high-fat meal did not change how much drug reached the blood. Adults start at 8.9mg (two 4.45mg tablets) in week 1, go to 17.8mg in week 2 and may go to the maximum of 35.6mg in week 3. Children 6 and older start at 4.45mg, then 8.9mg in week 2 and 17.8mg in week 3, which is the maximum under 40kg; children 40kg and over may go to 35.6mg from week 4.
Lower maximum doses apply for moderate liver impairment, kidney impairment (eGFR under 60), people whose bodies process the drug slowly (CYP2D6 poor metabolizers) and people taking strong CYP2D6 inhibitors; strong CYP3A4 inducers may call for a higher dose. It is not recommended in end-stage kidney disease. Some people may need up to 8 weeks to respond.
A missed dose is taken the next morning on waking. Tablets come in 4.45mg and 17.8mg strengths[1].
Availability and cost
Only available as the brand-name product.
Help paying for Wakix
With private insurance, the drugmaker's copay card can lower what you pay for Wakix. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 4 charity funds for Narcolepsy Type 1, 3 were open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Eligible patients with commercial insurance may be able to pay as little as $0 for Wakix. Not for government insurance. Harmony says additional terms and conditions apply.
For: private insurance · source - Insurance and case manager help
WAKIX for You helps with insurance coverage, points eligible patients to financial support programs, arranges delivery through a specialty pharmacy and assigns a Patient Case Manager. Phone 1-855-WAKIX4U (1-855-925-4948), Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, no insurance · source
Good to know: The page does not publish an annual copay maximum or a free-drug program. Generic pitolisant tablets are FDA approved but not confirmed on sale as of November 10, 2026.
Charity funds for Narcolepsy Type 1
- From a charity · NORD RareCareNarcolepsy Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting Applications” - From a charity · NORD RareCareNarcolepsy Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting Applications” - From a charity · TotalAssist (formerly PAN Foundation)Narcolepsy fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $5,000 per year. Requires health insurance (any kind).
- From a charity · The Assistance FundNarcolepsy fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
Clinical trial results
In 2 adult trials of daytime sleepiness that lasted 8 weeks (NCT01067222 and NCT01638403), Wakix lowered scores on the Epworth Sleepiness Scale, a 0 to 24 questionnaire where lower means less sleepy, by 3.1 and 2.2 points more than placebo[1][3][4]. In an adult cataplexy trial (NCT01800045, 105 people), weekly cataplexy attacks fell from about 9.1 to 2.3 on Wakix against 7.3 to 4.5 on placebo, a rate about half of placebo's[1][5].
A trial of 110 children aged 6 to 17 (NCT02611687) found less daytime sleepiness on a children's sleepiness scale after 8 weeks, and among the 95 children with cataplexy, weekly attacks averaged 2.2 against 5.6 on placebo[1][6]. Both adult sleepiness trials also had a modafinil group, but the label reports only the comparison with placebo, and the cataplexy and children's trials used placebo alone.
Development history
Pitolisant was developed by Bioprojet, the French company that ran the main trials, and Harmony Biosciences holds the US license[3][1]. The FDA approved Wakix on August 14, 2019 for excessive daytime sleepiness in adults with narcolepsy, then added adult cataplexy on October 13, 2020, daytime sleepiness in children 6 and older on June 21, 2024 and cataplexy in children 6 and older on February 13, 2026, according to Drugs@FDA[2].
Drugs@FDA also lists generic pitolisant tablets approved from July 2026 onward, from Novitium, Lupin, MSN and Annora; no primary source confirmed any of them on sale as of November 10, 2026[2].
Explore Narcolepsy Type 1 trials
Other Narcolepsy Type 1 treatments
Narcolepsy type 1 has been treated with wake-promoting drugs such as modafinil and armodafinil, stimulants, oxybate medicines taken at night, and pitolisant. Orzeyful, approved August 5, 2026, adds a treatment that acts on orexin receptors.
Common questions about Pitolisant
▸What is Pitolisant (Wakix)?
A once-daily morning tablet for excessive daytime sleepiness or cataplexy in people 6 years and older with narcolepsy. The FDA approved it for adult daytime sleepiness in August 2019 and added adult cataplexy in October 2020, daytime sleepiness in children 6 and older in June 2024 and cataplexy in children 6 and older in February 2026. Unlike the oxybate medicines and stimulants used in narcolepsy, Wakix is not a controlled substance.
▸How does Pitolisant work?
Narcolepsy type 1 is caused by the loss of brain cells that make orexin (also called hypocretin), a chemical messenger that keeps people awake and stabilizes muscle tone, which leads to overwhelming daytime sleepiness and cataplexy (sudden muscle weakness set off by strong emotions such as laughter). Histamine is another wake-promoting brain chemical, and the H3 receptor acts as a brake on how much of it nerve cells release. Pitolisant blocks that receptor, which is thought to raise histamine activity in the brain and promote wakefulness; the label says its exact mechanism in narcolepsy is unclear[1].
▸What are the side effects of Pitolisant?
Wakix has no boxed warning. In 3 placebo-controlled adult trials, the side effects seen in at least 5% of people and at least twice as often as on placebo were insomnia (6% against 2%), nausea (6% against 3%) and anxiety (5% against 1%). Headache was the most frequent side effect overall (18% against 15%), and others included upper respiratory infection, musculoskeletal pain, faster heart rate, hallucinations, irritability, abdominal pain and decreased appetite. Side effects led 3.9% of adults to stop, against 3.5% on placebo. In children 6 and older, the most common were headache (19%) and insomnia (7%). The label's 1 warning is QT prolongation, a change in the heart's electrical rhythm, so the label says to avoid it with other QT-prolonging drugs and in people with a history of heart rhythm problems, slow heart rate with symptoms, low potassium or magnesium, or a congenital long QT. It is not allowed in severe liver impairment or with a known allergy to pitolisant, and anaphylaxis has been reported after approval. Pitolisant can make hormonal birth control less effective during treatment and for 21 days after stopping[1].
▸How is Pitolisant taken?
Taken by mouth once a day in the morning on waking; the label reports that a high-fat meal did not change how much drug reached the blood. Adults start at 8.9mg (two 4.45mg tablets) in week 1, go to 17.8mg in week 2 and may go to the maximum of 35.6mg in week 3. Children 6 and older start at 4.45mg, then 8.9mg in week 2 and 17.8mg in week 3, which is the maximum under 40kg; children 40kg and over may go to 35.6mg from week 4. Lower maximum doses apply for moderate liver impairment, kidney impairment (eGFR under 60), people whose bodies process the drug slowly (CYP2D6 poor metabolizers) and people taking strong CYP2D6 inhibitors; strong CYP3A4 inducers may call for a higher dose. It is not recommended in end-stage kidney disease. Some people may need up to 8 weeks to respond. A missed dose is taken the next morning on waking. Tablets come in 4.45mg and 17.8mg strengths[1].
▸Is Pitolisant FDA approved?
Yes, Pitolisant (Wakix) is FDA approved (2019) for the treatment of Narcolepsy Type 1.
▸Is Wakix a controlled substance?
No. Wakix (pitolisant) has no DEA schedule, unlike the oxybate medicines (Xyrem, Xywav, Lumryz) and stimulants used in narcolepsy.
Label: Wakix has no boxed warning and no REMS program.
Source: Wakix label on DailyMed, revised February 2026
▸How long does Wakix take to work?
The label says some patients may need up to 8 weeks to respond.
Dose steps: adults start at 8.9mg and can reach the 35.6mg maximum in week 3; children follow smaller steps by weight.
Source: Wakix label on DailyMed, revised February 2026
▸Does Wakix affect birth control?
It can. Pitolisant can make hormonal contraceptives such as ethinyl estradiol less effective during treatment and for 21 days after stopping.
Label advice: use a non-hormonal method during treatment and for at least 21 days after the last dose.
Source: Wakix label on DailyMed, revised February 2026
▸What are the side effects of Wakix?
In adult trials the most common were insomnia (6% against 2% on placebo), nausea (6% against 3%) and anxiety (5% against 1%), and headache was frequent on both Wakix and placebo (18% against 15%).
Children: headache 19% and insomnia 7%.
Warning: QT prolongation, a change in the heart's electrical rhythm.
Source: Wakix label on DailyMed, revised February 2026
▸Is there a generic Wakix?
Generic pitolisant tablets are FDA approved, but none was confirmed on sale as of November 10, 2026.
Approved makers: Novitium, Lupin, MSN and Annora, from July 2026 onward.
Source: Drugs@FDA
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine · 2026-02. DailyMed - WAKIX- pitolisant hydrochloride tablet, film coated. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8daa5562-824e-476c-9652-26ceef3d4b0e
- U.S. Food and Drug Administration. Drugs@FDA: WAKIX (NDA 211150) approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211150
- ClinicalTrials.gov. Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. https://clinicaltrials.gov/study/NCT01067222
- ClinicalTrials.gov. Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.. https://clinicaltrials.gov/study/NCT01638403
- ClinicalTrials.gov. Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP). https://clinicaltrials.gov/study/NCT01800045
- ClinicalTrials.gov. Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period. https://clinicaltrials.gov/study/NCT02611687
- Harmony Biosciences. WAKIX for You Support Program | WAKIX® (pitolisant). https://wakix.com/wakix-for-you-support-program/