Wakix is a brand-name prescription medication. It’s FDA-approved for use in adults who have narcolepsy.

Narcolepsy is a condition that affects your nervous system. It can cause the following symptoms, which Wakix is approved to treat:

  • Excessive daytime sleepiness (EDS). With EDS, you have constant drowsiness and fatigue (lack of energy).
  • Cataplexy. With cataplexy, you have episodes of muscle weakness or limpness.

For more information about these symptoms of narcolepsy, and how Wakix is used to treat them, see the “Wakix for narcolepsy” section below.

Drug details

Wakix comes as a tablet that you take by mouth every day when you wake up. The tablets are available in two strengths: 4.45 mg and 17.8 mg.

The active drug in Wakix is pitolisant. It belongs to a group of medications known as histamine-3 blockers.

FDA approval

In 2019, Wakix was approved to treat EDS in adults with narcolepsy. Then later, in 2020, the drug was approved to treat cataplexy in adults with narcolepsy.

Wakix is the first drug to act on certain receptors in the brain called histamine-3 receptors. A receptor is a type of protein on a cell’s surface. It enables substances, such as the molecules of a drug, to attach to the protein and relay a chemical message.

Effectiveness

For information on the effectiveness of Wakix, see the “Wakix for narcolepsy” section below.

Wakix is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

The active drug in Wakix is pitolisant.

As with all medications, the cost of Wakix can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Wakix at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Wakix, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Wakix, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Wakix, or if you need help understanding your insurance coverage, help is available.

Harmony Biosciences LLC, the manufacturer of Wakix, offers a support program called WAKIX for You. This program includes financial support for people who qualify. For more information and to find out if you’re eligible for support, call 1-855-925-4948 or visit the program website.

Generic version

Wakix is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Wakix can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Wakix. These lists do not include all possible side effects.

For more information on the possible side effects of Wakix, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Wakix, you can do so through MedWatch.

Mild side effects

Mild side effects of Wakix can include*:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Wakix. To learn about other mild side effects, talk with your doctor or pharmacist, or view Wakix’s prescribing information.

Serious side effects

Serious side effects from Wakix aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects, explained below in “Side effect details,” can include:

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

No allergic reactions were reported in clinical studies of Wakix. However, as with most drugs, some people may have an allergic reaction after taking Wakix.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Wakix. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Hallucinations

While taking Wakix, some people may experience hallucinations (seeing or hearing things that aren’t really there). In clinical studies:

  • 3% of people who took Wakix reported hallucinations
  • 0% of people who took a placebo (a treatment with no active drug) reported hallucinations

Types of hallucinations reported in Wakix clinical trials included visual hallucinations and hypnagogic hallucinations. (Hypnagogic hallucinations occur when you’re asleep.)

If you experience hallucinations while taking Wakix, talk with your doctor. They can help determine if Wakix may be causing this side effect. They can also help find the best treatment for you.

Changes in your heart’s rhythm

It’s possible that you’ll experience changes to your heart rate and rhythm while taking Wakix.

In clinical studies:

  • 3% of people who took Wakix had their heart rate increase
  • 0% of people who took a placebo had their heart rate increase

Wakix is known to prolong (lengthen) a part of your heart rhythm known as the QT interval. When the QT interval is prolonged, it disrupts your heart rhythm. This can prevent your blood from carrying oxygen to your brain and other parts of your body.

People with a prolonged QT interval often don’t have symptoms, but you may experience:

  • fluttering feelings in your chest
  • passing out for no known reason
  • noisy gasping while sleeping

Although prolonged QT interval often doesn’t cause symptoms, in rare cases it can cause life threatening arrhythmia (irregular heartbeat).

Your doctor may monitor your QT interval while you’re taking Wakix. If you faint for no reason, or notice other symptoms of a prolonged QT interval, talk with your doctor. They may recommend a different medication for your condition.

Anxiety

Anxiety may be a side effect of Wakix. In clinical trials:

  • 5% of people who took Wakix had anxiety
  • 1% of people who took a placebo had anxiety

Talk with your doctor if you experience anxiety while taking Wakix. Your doctor may recommend ways to manage this side effect, or they may recommend a different medication to treat your narcolepsy.

Insomnia

Some people may experience insomnia (trouble sleeping) while taking Wakix. In clinical trials:

  • 6% of people who took Wakix had insomnia
  • 2% of people who took a placebo had insomnia

People who reported insomnia after taking Wakix had different types of issues with their sleep. Some people had trouble falling asleep, while others had trouble staying asleep. And some people reported a decrease in the quality of their sleep.

Wakix should be taken once in the morning as soon as you wake up. Taking the drug at this time may help lower your risk for experiencing insomnia.

If you have trouble sleeping while taking Wakix, talk with your doctor. They can recommend ways to help improve your sleep. They may also have you try a different drug to treat your narcolepsy.

Suicidal thoughts and behaviors

Suicidal thoughts and behaviors were not side effects reported in clinical trials of Wakix. However, these side effects have been reported since the drug was released onto the market. It’s not known how often they occur in people taking Wakix.

Your doctor will monitor you for any signs of suicidal thoughts and behaviors during your treatment.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

Was this helpful?

The Food and Drug Administration (FDA) approves prescription drugs such as Wakix to treat certain conditions.

Wakix is FDA-approved for use in adults who have narcolepsy.

Narcolepsy is a condition that affects your nervous system. It can cause the following symptoms, which Wakix is approved to treat:

  • Excessive daytime sleepiness (EDS). With EDS, you have constant drowsiness and fatigue (lack of energy).
  • Cataplexy. With cataplexy, you have episodes of muscle weakness or limpness. Cataplexy often occurs when you’re having strong emotions, such as when you’re laughing.

People with narcolepsy may also experience symptoms such as:

  • hallucinations (seeing or hearing things that aren’t actually there)
  • sleep attacks (suddenly falling asleep)
  • sleep paralysis (not being able to move while falling asleep, sleeping, or waking up)

Narcolepsy itself isn’t dangerous. But episodes of EDS or cataplexy can lead to accidents or injuries. For example, accidents or injuries could occur if you fall asleep while driving or using machinery.

It’s not known what causes narcolepsy. But it’s believed that genetics and certain environmental factors, such as stress, may play a role.

It isn’t known exactly how Wakix works to treat narcolepsy. Wakix is the first medication to increase histamine levels in the brain. However, it isn’t known for sure if this is how Wakix works to treat narcolepsy.

Effectiveness for narcolepsy

Clinical studies have shown Wakix to be effective for treating excessive daytime sleepiness (EDS) and narcolepsy in adults with narcolepsy.

Effectiveness for EDS

In one clinical study, adults with EDS related to narcolepsy received either Wakix or a placebo (a treatment with no active drug).

The researchers wanted to see if any treatment improved people’s scores on the Epworth Sleepiness Scale (ESS). This is a tool used to evaluate symptoms of daytime sleepiness. The maximum ESS score is 24, and a lower score indicates less severe narcolepsy symptoms.

At the end of the study:

  • people who took Wakix had their average ESS score drop from 17.8 to 12.4
  • people who took a placebo had their average ESS score drop from 18.9 to 15.5

Another study found similar results. In this study:

  • people who took Wakix had their average ESS score drop from 18.3 to 13.3
  • people who took a placebo had their average ESS score drop from 18.2 to 15.5

Effectiveness for cataplexy

In two clinical studies, adults with cataplexy related to narcolepsy received either Wakix or a placebo (a treatment with no active drug). Researchers looked to see if treatment reduced the number of cataplexy episodes the people had.

In the first study, over 4 weeks of treatment:

  • people taking Wakix had their average number of weekly cataplexy episodes decrease from 9.1 to 2.3
  • people taking a placebo had their average number of weekly cataplexy episodes decrease from 7.3 to 4.5

In the second study, over 8 weeks of treatment:

  • people taking Wakix had their average number of daily cataplexy episodes decrease from 0.4 to 0.1
  • people taking a placebo had their average number of daily cataplexy episodes decrease from 0.3 to 0.2

Wakix and children

Wakix is not approved for use in children. This drug hasn’t been studied in children, so it’s not known if it’s safe or effective for them.

If you have questions about treating narcolepsy in your child, talk with their pediatrician.

The Wakix dosage your doctor prescribes will depend on several factors. These include:

  • side effects that you experience while taking the drug
  • how well your symptoms respond to the drug
  • other medical conditions you may have
  • other medications you may take

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Wakix comes as a tablet that you take by mouth once every day when you wake up.

Wakix tablets are available in two strengths: 4.45 milligrams (mg) and 17.8 mg.

Dosage for narcolepsy

The Wakix dosage for treating excessive daytime sleepiness or cataplexy in adults with narcolepsy is the same. It starts with a dose of 8.9 mg and is increased to 17.8 mg or 35.6 mg. And it’s taken once every day when you wake up. Taking your Wakix dose too late in the day may cause you to have trouble sleeping.

For your first week of treatment, your dose will be 8.9 mg (two 4.45-mg tablets) taken once every day when you wake up. If you respond well to this dose, your doctor will likely increase your dose to 17.8 mg (one 17.8-mg tablet). You’ll take this dose every morning for a week.

In your third week of treatment, your doctor may increase your dose to the maximum dosage of 35.6 mg (two 17.8-mg tablets). You’ll likely take this dose if your symptoms haven’t responded to lower doses.

Your doctor may give you a different dosage depending on several factors, including whether you have side effects from taking Wakix, other medical conditions you have, or other medications you take. If you have questions about the dosage that’s right for you, talk with your doctor.

What if I miss a dose?

If you realize you missed a dose, just skip that dose. Take your next scheduled dose the next morning.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Wakix is meant to be used as a long-term treatment. If you and your doctor determine that Wakix is safe and effective for you, you’ll likely take it long term.

Other drugs are available that can treat the symptoms of narcolepsy. Some may be a better fit for you than others. If you’re interested in finding an alternative to Wakix, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for narcolepsy

Examples of other drugs that may be used to treat excessive daytime sleepiness and cataplexy in people with narcolepsy include:

You may wonder how Wakix compares with other medications that are prescribed for similar uses. Here we look at how Wakix and Sunosi are alike and different.

Ingredients

Wakix contains the active drug pitolisant. Sunosi contains the active drug solriamfetol.

Uses

Both Wakix and Sunosi have Food and Drug Administration (FDA) approval to treat excessive daytime sleepiness (EDS) in adults with narcolepsy.

Wakix is also FDA-approved to treat cataplexy in adults with narcolepsy. And Sunosi is also approved to treat EDS in adults with obstructive sleep apnea (OSA).

For more information about narcolepsy, see the “Wakix for narcolepsy” section above.

Drug forms and administration

Wakix and Sunosi are both tablets that you take by mouth every day when you wake up.

Side effects and risks

Wakix and Sunosi have some similar side effects and others that vary. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Wakix and Sunosi (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Wakix, with Sunosi, or with both drugs (when taken individually).

Effectiveness

These drugs haven’t been directly compared in clinical studies. However, studies have found both Wakix and Sunosi to be effective for treating narcolepsy.

Costs

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use. Wakix and Sunosi are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Wakix and Xyrem are prescribed for similar uses. Here’s a look at how these drugs are alike and different.

Ingredients

Wakix contains the drug pitolisant. Xyrem contains the drug sodium oxybate.

Uses

Both Wakix and Xyrem have Food and Drug Administration (FDA) approval to treat excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. Xyrem can also be used in children ages 7 years and older. But Wakix can only be used in adults ages 18 and older.

For more information about narcolepsy, see the “Wakix for narcolepsy” section above.

Drug forms and administration

Wakix is a tablet that you take by mouth every day when you wake up.

Xyrem comes as a liquid solution that you take by mouth. You’ll take one dose at bedtime, followed by another dose 2.5 to 4 hours later. Because Xyrem makes you fall asleep very quickly, you should only use it at bedtime.

Side effects and risks

Wakix and Xyrem have some similar side effects and others that vary. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Wakix and Xyrem (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Wakix, with Xyrem, or with both drugs (when taken individually).

* Xyrem has boxed warnings for the risks of CNS depression and drug misuse. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

These drugs haven’t been directly compared in clinical studies. However, studies have found both Wakix and Xyrem to be effective for treating narcolepsy.

One study looked at the effectiveness of both drugs in multiple clinical trials. Researchers found that Wakix may cause fewer side effects compared with Xyrem when treating EDS in people with narcolepsy.

Costs

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Wakix and Xyrem are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Here are answers to some frequently asked questions about Wakix.

Does Wakix cause weight loss?

In clinical trials, weight loss wasn’t a reported side effect of Wakix.

However, Wakix can cause decreased appetite in some people. 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.

Is Wakix a controlled substance?

No, Wakix isn’t a controlled substance. (A controlled substance is a drug regulated by federal law.) In fact, Wakix is the first medication that’s FDA-approved to treat narcolepsy that isn’t classified as a controlled substance.

This means the Drug Enforcement Administration (DEA) considers Wakix to have a lower potential for dependence, misuse, and addiction compared with other narcolepsy drugs.

Will Wakix cure my narcolepsy?

No, Wakix doesn’t cure narcolepsy. There is currently no cure for narcolepsy. However, medications like Wakix can help relieve your symptoms and reduce their impact on your daily life.

In clinical studies, Wakix improved people’s score on the Epworth Sleepiness Scale (ESS) compared with people who took a placebo. ESS is a tool used to evaluate daytime sleepiness. The maximum ESS score is 24, and a lower score indicates less severe narcolepsy symptoms.

Also, in the studies, Wakix helped lower the number of cataplexy episodes in people with narcolepsy.

If you have questions about treatment options for narcolepsy, talk with your doctor.

Is Wakix a stimulant?

No, Wakix isn’t a stimulant.

Stimulants are medications that excite your nervous system. They affect the release of certain “messenger” chemicals in the body like dopamine or norepinephrine.

These chemicals can give your more energy, but they may also raise your blood pressure and heart rate. Examples of stimulants approved for treating narcolepsy include modafinil (Provigil) and armodafinil (Nuvigil).

Wakix is a histamine-3 blocker, and it acts in a different way than stimulant medications. Although it’s not known exactly how Wakix works to treat narcolepsy, it’s known that it increases the amount of histamine in the brain. This differs from how stimulants work. (See the “How Wakix works” section to learn more.)

If you have other questions about how Wakix works to treat your narcolepsy, talk with your doctor.

Can I take Wakix if I have a liver or kidney condition?

It depends on how severe your condition is. If you have a severe liver condition (one that has a Child-Pugh score of “class C”), you shouldn’t take Wakix. This is because Wakix hasn’t been studied in people with severe liver conditions.

Your liver is essential for breaking down Wakix and removing it from your body. Therefore, if your liver isn’t working properly, your levels of Wakix may get too high. This can raise your risk for side effects.

You also shouldn’t use Wakix if you have end stage renal disease. It’s not known if people with this condition can properly break down Wakix.

If you have a mild to moderate kidney or liver condition, you may be able to safely use Wakix. Your doctor will review your health history and determine if Wakix is safe for you to use. They’ll also determine what dose may be safe for you to take.

Can I take birth control pills during my Wakix treatment?

No, Wakix shouldn’t be taken with birth control pills. Wakix may speed up how quickly your body breaks down birth control pills, which can make them less effective.

If you take birth control pills, you’ll need to use a different form of birth control while taking Wakix. You’ll also need to use a different form of birth control for at least 21 days after your last dose of Wakix.

See the “Wakix and birth control” section for more information. And if you have other questions about using birth control during your Wakix treatment, talk with your doctor.

There isn’t a known interaction between Wakix and consuming alcohol.

However, alcohol can affect your sleep. Research has shown that even one drink can lower your sleep quality. If you have narcolepsy, consuming alcohol may make your symptoms worse.

If you drink alcohol, talk with your doctor if you have questions about whether it’s safe to drink with your condition.

Wakix can interact with several other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Wakix and other medications

Below is a list of medications that can interact with Wakix. This list does not contain all drugs that may interact with Wakix.

Before taking Wakix, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Wakix and certain medications that increase Wakix levels

Taking Wakix with certain medications may increase the levels of Wakix in your body. This happens because these medications slow your body’s ability to break down Wakix. If Wakix levels build up in your body, it could raise your risk for side effects.

These drugs may increase Wakix levels because they block an enzyme called CYP2D6. Enzymes are proteins that help speed up processes in the body, such as breaking down drugs. CYP2D6 is an enzyme that helps your body break down Wakix.

Examples of medications that may block CYP2D6 and increase your levels of Wakix include:

If you take a medication that can increase Wakix levels in your body, your doctor will likely cut your Wakix dose in half. Or they may have you try a different medication to treat your narcolepsy.

Wakix and certain medications that decrease Wakix levels

Some medications can decrease the levels of Wakix in your body. That’s because these medications speed up your body’s ability to break down Wakix. Taking these medications with Wakix may result in Wakix being less effective.

These drugs may decrease Wakix levels because they increase the activity of an enzyme called CYP3A4. Enzymes are proteins that help speed up processes in the body, such as breaking down drugs. CYP3A4 is an enzyme that helps your body break down Wakix.

Examples of medications that can increase levels of Wakix in your body include:

  • rifampin (Rifadin)
  • carbamazepine (Tegretol)
  • phenytoin (Dilantin)

If you’re taking a medication that can decrease Wakix levels, your doctor may adjust your Wakix dose. Or they may have you try another medication to treat your condition.

Wakix and certain medications that can affect your heart rhythm

Wakix is known to prolong (lengthen) a part of your heart rhythm known as the QT interval. Wakix shouldn’t be used with other drugs that can prolong the QT interval.

When the QT interval is prolonged, it disrupts your heart rhythm. This can prevent your blood from carrying oxygen to your brain and other parts of your body.

Taking Wakix with other drugs that prolong the QT interval can raise your risk for prolonging your QT interval. This may raise your risk for problems with your heart rhythm.

Examples of other medications that can prolong the QT interval include:

  • amiodarone (Pacerone)
  • chlorpromazine
  • disopyramide (Norpace)
  • moxifloxacin (Avelox)
  • procainamide
  • quinidine
  • sotalol (Betapace)
  • ziprasidone (Geodon)
  • thioridazine

These drugs shouldn’t be taken with Wakix. Be sure to tell your doctor about all the medications you take before starting Wakix.

Wakix and medications that block histamine

Wakix increases the amount of histamine in your brain. Histamine is a chemical made by your body to help with several functions. In the brain, histamine helps send messages to the rest of your body.

Certain medications can block the actions of histamine. Taking these medications with Wakix could cause Wakix to be less effective.

Examples of medications that block histamine include:

  • diphenhydramine (Benadryl)
  • imipramine (Tofranil)
  • mirtazapine (Remeron)
  • pheniramine
  • promethazine
  • clomipramine (Anafranil)

You should avoid taking medications that block histamine while using Wakix. If you’re currently taking one of these drugs, tell your doctor before you begin taking Wakix.

Wakix and birth control pills

Wakix shouldn’t be taken with birth control pills. Wakix may speed up how quickly your body breaks down birth control pills, which can cause them to be less effective.

Examples of birth control pills include:

  • ethinyl estradiol/drospirenone/levomefolate calcium (Beyaz)
  • ethinyl estradiol/norethindrone acetate (Loestrin)
  • ethinyl estradiol/drospirenone (Yasmin, Yaz)

If you take birth control pills, you’ll need to use a different form of birth control while taking Wakix. You’ll also need to use a different form of birth control for at least 21 days after your last dose of Wakix.

If you have questions about using birth control during your Wakix treatment, talk with your doctor.

Wakix and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Wakix. However, you should still check with your doctor or pharmacist before using any of these products while taking Wakix.

Wakix and foods

There aren’t any foods that have been specifically reported to interact with Wakix. If you have any questions about eating certain foods with Wakix, talk with your doctor.

You should take Wakix according to your doctor or healthcare provider’s instructions.

Wakix comes as a tablet that you take by mouth.

When to take

You should take your Wakix dose every morning, right after waking up. Taking it too late in the day may make it hard for you to fall or stay asleep that night. That’s why it’s important you remember to take your dose at the right time.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Wakix with food

Wakix can be taken with or without food.

Can Wakix be crushed, split, or chewed?

You shouldn’t crush, split, or chew Wakix. If you’re having trouble swallowing Wakix tablets, talk with your doctor or pharmacist.

Wakix is approved to treat excessive daytime sleepiness (EDS) and cataplexy in adults who have narcolepsy. For information about these conditions, see the “Wakix for narcolepsy” section above.

What Wakix does

Wakix belongs to a group of medications known as histamine-3 blockers. It isn’t known exactly how Wakix works to treat narcolepsy.

Pitolisant, the active drug in Wakix, is the first medication to work on histamine-3 receptors and increase histamine levels in the brain. However, it isn’t known for sure if this is how Wakix works to treat narcolepsy.

How long does it take to work?

Wakix begins working as soon as you take your dose. However, it may take some time before you notice it relieving your EDS. In clinical trials, some people saw improvements in their cataplexy after just 4 weeks of treatment. But for other people, it took up to 8 weeks to see any improvement in their narcolepsy symptoms.

It isn’t known if Wakix is safe to use during pregnancy. A small number of reports on pregnant women who used the drug didn’t show an increased risk for major birth defects or miscarriage. However, without large clinical trials, these reports aren’t enough to be sure the drug is safe to use while pregnant.

In animal studies, pregnant rats given Wakix had decreased appetite and weight loss. The offspring of these rats had lower birth weights, decreased appetite, and convulsions.

At high doses, researched noted that the drug could cause deaths in the mother and stillbirth. These doses were much higher than the equivalent doses used in people. It’s also important to note that animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning a pregnancy, talk with your doctor about the risks and benefits of using Wakix.

Pregnancy registry

The manufacturer of Wakix has created a pregnancy registry to collect information on whether Wakix affects pregnancy. If you become pregnant while taking Wakix, you or your doctor can sign you up for the registry by calling 800-833-7460.

It’s not known if Wakix is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Wakix.

Wakix may make birth control pills less effective. Examples of birth control pills include:

  • ethinyl estradiol/drospirenone/levomefolate calcium (Beyaz)
  • ethinyl estradiol/norethindrone acetate (Loestrin)
  • ethinyl estradiol/drospirenone (Yasmin, Yaz)

If you or your partner use birth control pills, you’ll need to use a different form of birth control while taking the drug. You’ll also need to use a different form of birth control for at least 21 days after your last dose of Wakix.

For more information about taking Wakix during pregnancy, see the “Wakix and pregnancy” section above.

It isn’t known if Wakix is safe to take while breastfeeding. This is because the drug hasn’t been studied in breastfeeding women.

Animal studies show the drug passes into the milk of lactating rats. However, it isn’t known what, if any, effects this has on the offspring.

It’s important to note that animal studies don’t always predict what will happen in people. If you have questions about breastfeeding while taking Wakix, talk with your doctor.

Before taking Wakix, talk with your doctor about your health history. Wakix may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Abnormal heart rhythm. You shouldn’t take Wakix if you have an abnormal heart rhythm, including QT prolongation. Wakix may make your condition worse. Before taking Wakix, be sure to tell your doctor if you have a history of abnormal heart rhythm.
  • Electrolyte disorders. People with certain electrolyte disorders may have a higher risk for serious heart side effects from Wakix. Examples of these disorders include having low levels of potassium or magnesium. If you have a known electrolyte disorder, tell your doctor before taking Wakix.
  • Kidney or liver disease. Your body depends on your kidneys and liver to break down Wakix and remove it from your body. If you have kidney disease or liver disease, your body may not be able to get rid of Wakix as well. This can raise your risk for side effects. Before taking Wakix, be sure to tell your doctor if you have a history of kidney or liver disease. If you have severe liver disease, you shouldn’t take Wakix.
  • Allergic reaction. If you’ve had an allergic reaction to Wakix or any of its ingredients, you shouldn’t take Wakix. Ask your doctor about other medications that may be better options for you.
  • Pregnancy. It isn’t known if Wakix is safe to take while pregnant. For more information, see the “Wakix and pregnancy” section above.
  • Breastfeeding. It isn’t known if Wakix is safe to use while breastfeeding. For more information, see the “Wakix and breastfeeding” section above.

Note: For more information about the potential negative effects of Wakix, see the “Wakix side effects” section above.

Do not use more Wakix than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Wakix

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Wakix from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Wakix tablets should be stored at a room temperature of 68°F to 77°F (20°C to 25°C) in a tightly sealed container away from light. For short periods of time, such as when traveling, you may store Wakix at a temperate of 59°F to 86°F (15°C to 30°C) before returning the medication to room temperature as soon as possible.

Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Wakix and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Wakix is indicated to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Administration

Wakix tablets are given once daily upon waking up in the morning.

The titration schedule for Wakix is as follows:

  • Week 1: 8.9 mg (two 4.45-mg tablets) once daily in the morning
  • Week 2: Increase dose to 17.8 mg (one 17.8-mg tablet) once daily in the morning
  • Week 3: If necessary, dose may be increased to 35.6 mg (two 17.8-mg tablets) once daily in the morning (this is the maximum recommended dose)

The dose of Wakix should be adjusted based on the person’s response. Depending on the condition being treated, a clinical response may not be seen for up to 4 to 8 weeks after starting the drug.

Mechanism of action

Wakix’s mechanism of action for treating narcolepsy is unknown. The active drug in Wakix, pitolisant, is an antagonist/inverse agonist for histamine-3 receptors.

Pharmacokinetics and metabolism

Wakix’s oral bioavailability is 90%. Maximum plasma concentrations are reached in about 3.5 hours after a dose. Following once daily dosing, Wakix reaches steady-state within 7 days. The median half-life is about 20 hours.

Pitolisant exhibits protein binding at approximately 91% to 96%. It is extensively metabolized in the liver, primarily by CYP2D6, with lesser involvement by CYP3A4.

Contraindications

Wakix is contraindicated in persons with severe hepatic impairment.

Storage

Store Wakix tablets at a room temperature of 68°F to 77°F (20°C to 25°C) in a tightly sealed container away from light. Wakix may be stored at a temperature of 59°F to 86°F (15°C to 30°C) for short periods of time before returning the medication to room temperature as soon as possible.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Wakix Images