Qelbree (viloxazine)

Qelbree generic

Qelbree 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. Typically, a medication’s generic name is the same as its active drug name. Generics typically cost less than brand-name drugs.

Qelbree side effects

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

Note that Qelbree’s side effects may vary depending on the age of the person taking it.

For more information about the possible side effects of Qelbree for ADHD, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome. In addition to the information below, you can refer to this article for details about Qelbree’s side effects.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Qelbree, you can do so through MedWatch.

Mild side effects

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

Mild side effects of Qelbree reported in adults include:

• insomnia
• headache
• mild drowsiness
• mild fatigue
• decreased appetite
• dry mouth
• constipation
• dizziness
• mild allergic reaction*

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

* For more information about allergic reaction and Qelbree, see “Allergic reaction” below.

Serious side effects

Serious side effects from Qelbree aren’t common. However, 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 and their symptoms can include:

• Increased heart rate. Symptoms can include:
  • heart palpitations
  • nausea
  • feeling lightheaded
  • fainting
• High blood pressure, which typically doesn’t cause symptoms. However, symptoms of very high blood pressure may include:
  • intense headache
  • chest pain
  • blurred vision
  • confusion
• Severe drowsiness.
• Severe fatigue.
• Suicidal thoughts and behaviors.*
• Severe allergic reaction.†

* Qelbree has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Qelbree precautions” section below.
† For details about allergic reaction and Qelbree, see “Allergic reaction” below.

Side effects in children

Side effects of Qelbree in children ages 6 to 17 years may include:

• drowsiness
• decreased appetite
• fatigue
• nausea
• vomiting
• insomnia
• irritability

Several of these side effects may also occur in adults. However, there were differences in how commonly these side effects occurred in separate clinical trials of Qelbree in adults compared with children. For example, in clinical trials in adults, Qelbree’s most common side effect was insomnia. And in the drug’s clinical trials in children, the most common side effect was drowsiness.

Your child’s doctor will monitor your child’s weight regularly during Qelbree treatment. This is because children taking Qelbree may experience weight changes. In a short-term clinical trial comparing Qelbree to a placebo,* the following occurred:

• Children ages 6 to 11 years who took Qelbree had an average weight gain of 0.2 kilograms (kg). This is about 0.4 pounds (lb). In comparison, children ages 6 to 11 years who took a placebo in this trial had an average weight gain of 1 kg (about 2.2 lb).
• Children ages 12 to 17 years who took Qelbree had an average weight loss of 0.2 kg (about 0.4 lb). In comparison, children who took a placebo in this trial had an average weight gain of 1.5 kg (about 3.3 lb).

In children, certain side effects of Qelbree, such as decreased appetite and vomiting, may contribute to weight loss. Talk with your child’s doctor if your child has weight changes during treatment with Qelbree.

To learn about other possible side effects and how to manage them, talk with your child’s doctor or read Qelbree’s prescribing information.

* A placebo is a treatment that contains no active drug.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Qelbree. This side effect wasn’t reported in clinical trials of this drug. However, it can still occur.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare. However, it is 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 an allergic reaction to Qelbree, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Qelbree for ADHD

The Food and Drug Administration (FDA) approves prescription drugs such as Qelbree to treat certain conditions. Qelbree may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Qelbree for ADHD in adults

Qelbree is FDA-approved to treat attention deficit hyperactivity disorder (ADHD) in adults. It’s also approved to treat ADHD in children ages 6 years and older.

ADHD explained

ADHD is a common condition that typically starts in childhood. However, it can continue into adult life.

Symptoms of ADHD may include:

• trouble concentrating
• fidgeting or moving around
• difficulty getting organized or completing tasks
• getting easily distracted
• acting without thinking of the consequences
• trouble with time management

With ADHD, symptoms often cause problems at work or school and in relationships.

ADHD treatment approaches may include cognitive behavioral therapy and medication. One such medication is Qelbree. Talk with your doctor if you have questions about your condition or treatment options.

Effectiveness for ADHD

In clinical trials, Qelbree has been shown to be an effective treatment for ADHD in adults and children ages 6 years and older.

For details on how Qelbree performed in clinical trials, see the drug’s prescribing information.

Qelbree and children

In clinical trials, Qelbree has been shown to be an effective treatment for ADHD in children ages 6 to 17 years.

For details on how Qelbree performed in clinical trials, see the drug’s prescribing information.

Common questions about Qelbree

Here are answers to some frequently asked questions about Qelbree.

How does Qelbree compare with other ADHD medications, such as Strattera and Adderall?

Qelbree, Strattera, and Adderall are similar because they are all approved to treat attention deficit hyperactivity disorder (ADHD).

Several ADHD medications, such as Adderall, belong to a drug class called stimulants. Qelbree and Strattera are not stimulants.

Talk with your doctor if you have questions about the best treatment option for your ADHD.

Is there a coupon for Qelbree?

There is a Qelbree savings card available to eligible adults and children. Details about the savings card can be found on the manufacturer’s website. It works differently than a coupon because you’ll need to sign up for it. And people with certain insurance plans may not qualify.

If you have questions about saving money on prescription drugs, including Qelbree, talk with your pharmacist.

Is Qelbree a controlled substance?

No, Qelbree is not a controlled substance.

Controlled substances are drugs that have a risk of dependence or misuse. (With dependence, your body gets used to a drug and needs the drug to function as it typically would. With misuse, you take a drug for a different purpose that it wasn’t prescribed for or in a way that’s not approved.) They’re called “controlled” substances because the United States government regulates how these drugs are made, prescribed, and dispensed.

Qelbree isn’t known to carry risks of dependence or misuse.

If you have concerns about your risk of dependence or misuse with Qelbree, talk with your doctor or pharmacist.

Alternatives to Qelbree

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Qelbree, 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 drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for ADHD

Examples of other drugs that may be used to treat attention deficit hyperactivity disorder (ADHD) include:

• amphetamine (Evekeo, Dyanavel XR)
• amphetamine/dextroamphetamine (Adderall, Adderall XR, Mydayis)
• atomoxetine (Strattera)
• bupropion (Wellbutrin XL)
• clonidine (Kapvay)
• dexmethylphenidate (Focalin, Focalin XR)
• dextroamphetamine (Dexedrine)
• lisdexamfetamine (Vyvanse)
• methylphenidate (Concerta, Daytrana, Quillivant XR, Ritalin, others)
• serdexmethylphenidate/dexmethylphenidate (Azstarys)

Qelbree dosage

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

• the severity of the condition you’re taking Qelbree to treat
• your age
• other medical conditions you may have

Typically, your doctor will start you taking a low dose. 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.

Note: In addition to the information below, you can also refer to this article for details about Qelbree’s dosage.

Drug form

Qelbree comes as an extended-release oral capsule. Extended release means the active drug is released into your body over a period of time.

Drug strengths (100 mg, 150 mg, and 200 mg)

Qelbree comes in three strengths:

• 100 milligrams (mg)
• 150 mg
• 200 mg

Dosage for ADHD

Qelbree is approved to treat attention deficit hyperactivity disorder (ADHD) in adults and children ages 6 years and older.

The recommended starting dose of Qelbree in adults is 200 mg. The dosing schedule for Qelbree is once per day. Depending on your body’s response to Qelbree, your doctor may adjust your dose over time to reach the amount that’s right for you. The dose shouldn’t be increased more often than once per week.

The maximum dose of Qelbree for adults is 600 mg.

Children’s dosage

Qelbree is also approved to treat ADHD in children ages 6 to 17 years. The table below shows the typical dosages of Qelbree in children.

Depending on your child’s response to Qelbree, their doctor may adjust the dose over time to reach the amount that’s right for your child. The dose shouldn’t be increased more often than once per week.

What if I miss a dose?

If you miss your dose of Qelbree, contact your doctor. They can recommend the best time for you to take your next dose. Their advice will likely depend on how soon your next scheduled dose is.

Your doctor may recommend taking the missed dose as soon as possible. However, if it’s almost time for your next dose, they may recommend skipping the missed dose. Then, you’ll take your next dose at your regular time.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to take this drug long term?

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

How Qelbree works

Qelbree is approved to treat attention deficit hyperactivity disorder (ADHD) in adults and children ages 6 years and older.

Qelbree comes as an extended-release capsule. It releases the active drug into your body over a period of time.

The half-life of Qelbree is approximately 7 hours. (A drug’s half-life is the time it takes for your body to clear half of one dose.)

What is Qelbree’s mechanism of action?

Experts don’t fully understand how Qelbree works to treat ADHD. Qelbree belongs to an antidepressant drug class called selective norepinephrine reuptake inhibitors. (Even though it’s considered an antidepressant, Qelbree isn’t approved by the Food and Drug Administration [FDA] to treat depression. Instead, it’s FDA-approved to treat ADHD in adults and children ages 6 years and older.)

Qelbree is thought to work by making more norepinephrine and other neurotransmitters available in the brain. (Neurotransmitters are chemicals that send messages from one brain cell to another.) It’s thought that increased amounts of norepinephrine and other neurotransmitters in the brain can improve your ability to focus.

How long does it take to work?

It may take several weeks of Qelbree treatment before you notice a reduction in your ADHD symptoms. This is because the drug is typically started at a low dose. Your doctor will adjust your dosage each week until they determine the dosage that’s best for treating your ADHD symptoms.

If you have questions about how Qelbree works or what to expect from treatment, talk with your doctor or pharmacist.

Qelbree cost

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

Keep in mind that you may be able to get a 90-day supply of Qelbree. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

Before approving coverage for Qelbree, 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 whether the drug will be covered.

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

Financial and insurance assistance

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

A program called Supernus Support is available for Qelbree. For more information and to find out whether you’re eligible, call 866-398-0833 or visit the program website for adults or children.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Qelbree may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Qelbree, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Qelbree 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.

Qelbree precautions

This drug comes with several precautions. These are known as drug-condition interactions.

FDA warning: Suicidal thoughts and behaviors

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Suicidal thoughts and behaviors. In clinical trials, higher rates of suicidal thoughts and behaviors were reported in people who took Qelbree compared with people who took a placebo. (A placebo is a treatment that contains no active drug.)

In this trial, Qelbree and a placebo were compared for the treatment of attention deficit hyperactivity disorder (ADHD). No individuals in either group died by suicide. Suicidal thoughts and behaviors may be more likely to occur during the first few months of treatment or after your doctor changes your dosage. However, the overall risk of having suicidal thoughts and behaviors during Qelbree treatment is low.

Because of this risk, your doctor will have you watch for any warning signs. These are symptoms that sometimes occur before someone develops suicidal thoughts or behaviors. These warning signs, which may be severe or start suddenly, can include:

• insomnia
• irritability
• agitation (feeling agitated or restless)
• anxiety
• depression
• mania (episode of increased activity and extremely high energy)
• panic attacks
• engaging in risky behavior
• hostile behavior

Tell your doctor right away if you (or others around you) notice these warning signs while taking Qelbree. Your doctor will talk through your symptoms with you and recommend ways to help. They may also have you stop taking Qelbree or switch you to a different ADHD treatment.

Other precautions

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

• Personal or family history of mental illness. In clinical trials, some people who took Qelbree reported having suicidal thoughts or behaviors. If you or someone in your family has a mental illness, such as bipolar disorder, depression, mania, or hypomania, talk with your doctor. They’ll likely monitor you closely for changes in your thoughts and behavior if they prescribe Qelbree to you. Also, tell your doctor if anyone in your family died by suicide. Your doctor will determine whether or not Qelbree is right for you.
• Blood pressure or heart rate problems. Qelbree may cause increases in blood pressure or heart rate. If you have high blood pressure or a condition that affects your blood pressure or heart rate, taking Qelbree may worsen your condition. Your doctor will check your blood pressure and heart rate during Qelbree treatment. They may also have you monitor your blood pressure and heart rate at home.
• Severe kidney problems. People with severe kidney problems may have trouble removing Qelbree from the body. If the drug stays in your body longer than is typical, your risk of side effects increases. So it’s important to tell your doctor if you’ve had kidney problems. They’ll check the health of your kidneys and, if necessary, they’ll likely prescribe a low dosage of Qelbree.
• Allergic reaction. If you’ve had an allergic reaction to Qelbree or any of its ingredients, your doctor will likely not prescribe Qelbree. Ask your doctor what other medications may be better options for you.
• Pregnancy. It’s not known whether Qelbree is safe to take during pregnancy. For more information, see the “Qelbree and pregnancy” section below.
• Breastfeeding. It’s not known whether Qelbree is safe to take while breastfeeding. For more information, see the “Qelbree and breastfeeding” section below.

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

Qelbree withdrawal and dependence

Qelbree shouldn’t cause drug dependence. With drug dependence, your body gets used to a drug and needs it to function as it typically would.

Stopping Qelbree shouldn’t cause withdrawal symptoms. (Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on.) However, you should not stop taking Qelbree without first talking with your doctor. This is because your attention deficit hyperactivity disorder (ADHD) symptoms will likely return. Instead, your doctor may recommend a different treatment option for your ADHD if you’d like to stop taking Qelbree.

How to take Qelbree

You should take Qelbree according to the instructions your doctor gives you.

When to take

Qelbree should be taken by mouth once per day. The drug may be taken during the day or at night. It’s best to take Qelbree around the same time each day. This helps keep a steady level of the drug in your body, which helps it to work effectively.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

If you have trouble opening medication bottles, ask your pharmacist whether they can put Qelbree in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.

Taking Qelbree with food

Qelbree may be taken with or without food.

Can Qelbree be crushed, cut, or chewed?

No, you should not crush, cut, or chew Qelbree. Here are two options for taking Qelbree capsules:

• Swallow the capsule whole.
• Alternatively, open the capsule and sprinkle the contents over a teaspoonful or tablespoonful of pudding or applesauce. Swallow the mixture right away, without chewing. Be sure to swallow the whole mixture within 15 minutes if you use pudding or within 2 hours if you use applesauce.

Qelbree interactions

Qelbree can interact with several other medications. It can also interact with certain supplements as well as certain foods.

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. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Qelbree precautions” section above.

Qelbree and other medications

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

Before taking Qelbree, 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.

Certain drugs are known to cause high blood pressure. Qelbree may also cause increases in heart rate and blood pressure. Due to this risk, doctors typically will not prescribe Qelbree with medications from a drug class called monoamine oxidase inhibitors (MAOIs). Also, doctors will not prescribe Qelbree within 14 days after your last dose of an MAOI. Examples of MAOIs include:

• isocarboxazid (Marplan)
• linezolid (Zyvox)
• phenelzine (Nardil)
• selegiline (Emsam, Zelapar)
• tranylcypromine (Parnate)

Also, Qelbree may interact with drugs that are metabolized (broken down) by an enzyme in the body called CYP1A2. Qelbree may slow or block this enzyme, causing increased exposure to certain other drugs. This could increase the risk of the other drugs’ side effects. This interaction may prevent doctors from prescribing Qelbree with specific drugs due to the risk of harm. Examples of drugs metabolized by CYP1A2 are:

• flecainide
• theophylline (Theo-24)
• warfarin (Jantoven)

Taking Qelbree with certain other drugs could lower the effectiveness of the other drugs. Additionally, Qelbree could increase the risk of side effects of some other drugs. Examples include:

• dextromethorphan (Delsym)
• midazolam

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

Qelbree and herbs and supplements

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

Qelbree and foods

Caffeine may interact with Qelbree and could increase the risk of side effects, such as a fast heart rate. If you have any questions about limiting or avoiding caffeine while taking Qelbree, talk with your doctor.

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

Qelbree and alcohol

If you drink alcohol, your doctor will likely recommend that you limit how much you drink while taking Qelbree.

Based on the findings of a clinical trial, high concentrations of alcohol may interact with Qelbree. So it’s possible that drinking certain types of alcohol may increase the risk of developing side effects of Qelbree.

If you consume alcohol, talk with your doctor about whether it’s safe to drink while you take Qelbree.

Qelbree and pregnancy

It’s not known whether Qelbree is safe to take during pregnancy. The drug’s effects haven’t been clinically trialed in people who are pregnant.

In animal studies, the drug caused harmful effects in pregnant animals and their fetuses. Keep in mind that the results of animal studies don’t always predict what may happen in humans.

However, because of the risk of harm, it’s likely that your doctor will not prescribe Qelbree if you’re pregnant or planning to become pregnant. And they’ll likely have you stop taking Qelbree if you become pregnant during treatment.

If you’re pregnant or planning to become pregnant, talk with your doctor about the risks and benefits of Qelbree.

Pregnancy registry

There is a pregnancy registry that monitors pregnancy outcomes of people who took Qelbree while pregnant. This registry helps doctors and patients learn more about possible drug effects during pregnancy. If you become pregnant while taking the drug, your doctor may encourage you to visit the website or call 866-961-2388 to register.

Qelbree and birth control

It’s not known whether Qelbree 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 taking Qelbree.

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

Qelbree and breastfeeding

It’s not known whether Qelbree is safe to take while breastfeeding. There haven’t been any clinical trials of Qelbree’s effects on breast milk or children who are breastfed.

In clinical trials of lactating rats, the drug seemed to pass into their milk. However, animal studies don’t always predict what may happen in humans.

Before starting Qelbree, talk with your doctor if you’re breastfeeding or planning to breastfeed. They’ll help you determine the best way to feed your child and treat your condition.

Qelbree overdose

Taking more than the recommended dosage of Qelbree can lead to serious side effects. Do not take more Qelbree than your doctor recommends. (For information on the recommended dosages of Qelbree, see the “Qelbree dosage” section above.)

Overdose symptoms

Symptoms of an overdose of viloxazine (the active drug in Qelbree) can include:

• drowsiness
• increased heart rate
• decreased consciousness (reduced awareness of your surroundings)
• weak reflexes (reflexes are automatic body movements in response to a stimulus, such as the “knee-jerk” reaction to a tiny hammer)

What to do in case of overdose

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