Pitolisant
Pitolisant is a prescription medicine used to treat excessive daytime sleepiness and cataplexy in people with narcolepsy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Pitolisant: Patient Information Guide
A plain-language walkthrough of Pitolisant — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pitolisant (brand name Wakix) is approved to treat the following conditions in patients 6 years of age and older with narcolepsy:
- Excessive daytime sleepiness (EDS) — an overwhelming urge to sleep during the day that interferes with daily life, a core symptom of narcolepsy.
- Cataplexy — sudden, brief episodes of muscle weakness or paralysis, often brought on by strong emotions, that occur in people with narcolepsy.
Both indications apply to Wakix tablets taken orally. Pitolisant is not approved for sleepiness or cataplexy unrelated to narcolepsy.
⚙️How it works▾
Pitolisant acts on a specific brain receptor called the histamine-3 (H3) receptor, blocking it (acting as an antagonist and inverse agonist). H3 receptors normally act like a brake on the release of histamine and other wake-promoting brain chemicals. By blocking these receptors, pitolisant is believed to lift that brake and increase wakefulness-promoting activity in the brain. The precise mechanism behind its benefit in narcolepsy is not fully established, but this receptor activity is the most plausible explanation.
💊How it's taken▾
Wakix is taken as an oral tablet once a day, in the morning when you wake up. It can be taken with or without food — even a high-fat meal doesn't meaningfully change how it's absorbed.
- Dosing is started at a low level and increased gradually over several weeks to reduce side effects.
- The starting schedule and maximum dose differ for adults versus children — your prescriber will set the right plan for you or your child.
- People with moderate liver or kidney impairment need a dose adjustment; always inform your prescriber about these conditions.
If you miss a dose, follow your prescriber's guidance — do not double up without being told to do so.
🤒Side effects — in detail▾
The most commonly reported side effects with Wakix include:
- Headache
- Insomnia (trouble sleeping)
- Nausea
- Anxiety or nervousness
- Upper respiratory infections (cold-like symptoms)
- Increased heart rate
- Decreased appetite
- Irritability
- Hallucinations (seeing or hearing things that aren't there)
Seek medical attention right away if you experience signs of a serious allergic reaction (hives, swelling, difficulty breathing), an irregular or racing heartbeat, feelings of depression, or any thoughts of self-harm — these are rare but serious reactions that require prompt care.
⚠️Warnings & precautions▾
QT prolongation (heart rhythm change) is the most significant risk with Wakix. This refers to a lengthening of the electrical signal in the heart that can — in serious cases — lead to a dangerous irregular heartbeat called torsade de pointes. The risk is higher in people with liver or kidney problems (because the drug builds up more), those with naturally low potassium or magnesium, those with a slow heart rate, and those already on other medications that affect heart rhythm. Wakix should be avoided in these situations, and your doctor may monitor your heart with an ECG if you are at higher risk.
Post-marketing experience has also flagged psychiatric concerns, including depression, suicidal ideation, abnormal behavior, and mood changes. Although these are rare reports, it's important to monitor for any unusual changes in mood or behavior — especially in younger patients — and contact a healthcare provider promptly if they occur.
🔀What it interacts with▾
Several drug interactions are clinically important with Wakix:
- Strong CYP2D6 inhibitors (certain antidepressants, some antifungals): raise pitolisant blood levels significantly, increasing side effect risk — dose reduction is needed.
- Strong CYP3A4 inducers (such as rifampin or certain seizure medications): lower pitolisant levels and may reduce its effectiveness — dose increase may be needed.
- Sedating antihistamines (medicines that cross into the brain to block histamine, like diphenhydramine): may counteract Wakix's mechanism and reduce its effectiveness; avoid concurrent use.
- QT-prolonging drugs (some antibiotics, antifungals, antiarrhythmics, antipsychotics): combined use raises the risk of dangerous heart rhythm problems; avoid combination.
- Hormonal contraceptives (birth control pills, patches, vaginal rings): Wakix may reduce their effectiveness. Use a non-hormonal contraceptive method while on Wakix and for at least 21 days after stopping it.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Severe liver disease: Wakix is contraindicated — do not use it.
- Moderate liver or kidney disease: Dose adjustments are required; your doctor will monitor you more closely.
- End-stage renal disease (kidney failure): Wakix is not recommended.
- Heart rhythm problems or QT prolongation history: Inform your doctor — Wakix may not be safe for you.
- Low potassium or magnesium levels, or slow heart rate: These raise the risk of heart rhythm problems with Wakix.
- Pregnancy: Human data are limited. Animal studies showed harm at high doses. A pregnancy registry exists (call 1-800-833-7460). Discuss risks with your doctor.
- Breastfeeding: Pitolisant passes into breast milk in small amounts. Discuss the benefits and risks with your healthcare provider before breastfeeding.
- Hormonal contraception users: Wakix can reduce effectiveness — switch to a non-hormonal method during treatment and for 21 days after stopping.
- Children under 6: Safety and effectiveness have not been established in this age group.
- Older adults: Use with extra caution — start at the lower end of dosing, and account for any liver, kidney, or heart concerns common in this age group.
📡Pharmacodynamics — effects in the body▾
Pitolisant binds very selectively and with high affinity to histamine-3 (H3) receptors in the brain, with little to no activity at other histamine receptor types (H1, H2, H4). At its highest recommended dose, Wakix causes a small but measurable increase in the QTc interval — a measure of heart electrical activity — of about 4 milliseconds. At exposures substantially above the recommended dose, this QTc increase becomes more pronounced, which is why avoiding excessive drug levels (for example, in liver or kidney impairment) and drug combinations that also affect QTc is important.
🔬Pharmacokinetics — how your body processes it▾
After you take a Wakix tablet by mouth, about 90% of the dose is absorbed, with peak blood levels reached in roughly 3 to 4 hours. The drug has a half-life of about 20 hours, meaning it takes roughly a day to clear half the dose from your body, and steady, consistent blood levels are reached by about one week of daily dosing. Pitolisant is heavily processed by the liver (so liver disease significantly affects how much drug stays in your body), and it is highly bound to proteins in the blood. Food — even a high-fat meal — does not meaningfully affect how the drug is absorbed.
📦How to store it▾
Store at 20° C to 25° C (68° F to 77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) .
📄 Written from Pitolisant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Pitolisant
158 supplements and herbal products have documented interactions with Pitolisant in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 114
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pitolisant — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Wakix supposed to do for me? ▾
When should I take it, and does it matter if I eat first? ▾
What side effects are most likely to happen? ▾
I'm on birth control pills — is that a problem? ▾
Is it safe to take Wakix if I have liver or kidney problems? ▾
Can I take over-the-counter allergy medicines like Benadryl while on Wakix? ▾
Is Pitolisant available over the counter? ▾
When was Pitolisant first available? ▾
Who makes Pitolisant? ▾
💬 Answers drafted from Pitolisant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Pitolisant comes
Pitolisant is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Wakix tablets are used to treat excessive daytime sleepiness in patients 6 years and older with narcolepsy.
- Wakix tablets are used to treat cataplexy (sudden episodes of muscle weakness) in patients 6 years and older with narcolepsy.
- Wakix tablets are taken by mouth once daily in the morning upon waking.
- Wakix tablets can be taken with or without food — a high-fat meal does not significantly affect absorption.
- Wakix dosing is started low and gradually increased over several weeks; follow your prescriber's schedule exactly.
- Wakix tablets should not be taken by patients with severe liver disease — this is a contraindication.
📊 Pitolisant across the U.S. market
How Pitolisant appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Pitolisant is used
A general measure of how commonly Pitolisant is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Pitolisant is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Pitolisant prescribed? Of the 1,596 medications we measure, Pitolisant ranks #923 by Medicaid prescriptions — more than 42% of them.
Utilization by Pitolisant product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
pitolisant 17.8 MG Oral Tablet Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2197892
pitolisant 4.45 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2197884
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pitolisant, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 5 listed Pitolisant NDCs with Medicaid activity.
🔍 Compare Pitolisant products
A representative set of FDA-listed product records for Pitolisant — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 4.45 mg | Oral | Harmony Biosciences, LLC × 3 listings | NDA | View NDC → |
| 17.8 mg | Oral | Harmony Biosciences, LLC × 3 listings | NDA | View NDC → |
| 4.45 mg | — | Patheon France S.A.S | DRUG FOR FURTHER PROCESSING | View NDC → |
| 17.8 mg | — | Patheon France S.A.S | DRUG FOR FURTHER PROCESSING | View NDC → |
| 4.45 mg | — | Patheon Pharmaceuticals Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 25 kg/25 kg | — | Biophore India Pharmaceuticals Pvt. Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dasami Lab Private Limited | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Emnar Pharma Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 35 kg/35 kg | — | Nuray Chemicals Private Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | PROCOS SpA | BULK INGREDIENT | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Pitolisant NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pitolisant — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pitolisant in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Pitolisant went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2197878 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 2197883In current FDA listings
Look up RxCUI 2197878 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Pitolisant is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Pitolisant belongs to the Histamine-3 Receptor Antagonist/Inverse Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Harmony Biosciences, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.