Qelbree (Viloxazine): Uses, Dosage, Side Effects, & More

What Is Qelbree?

Qelbree (viloxazine) is a non-stimulant ADHD medication approved to treat attention-deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. There is no generic for Qelbree. It works by adjusting certain brain chemicals to help manage symptoms of ADHD, such as inattention, hyperactivity, and impulsivity. Qelbree offers an alternative treatment option to traditional stimulant medications (such as Adderall) and may be suitable for individuals who prefer or require a non-stimulant approach to managing ADHD.¹

How Does Qelbree Work?

Low levels of certain key chemicals in the brain (like norepinephrine) are thought to contribute to ADHD symptoms like inattention and poor impulse control. Qelbree is a medication designed to help improve these symptoms by helping boost chemical levels, especially norepinephrine (NE). Although the specifics are unknown, they appear to be most similar to medications like Strattera. Qelbree dosage must be adjusted when starting or stopping (slowly increasing the dose when starting or slowly decreasing the dose when stopping), so it is important to follow your doctor’s instructions and not stop taking Qelbree suddenly.^{1, 3}

How Is Qelbree Different from Adderall?

Qelbree and Adderall are both medications to treat ADHD symptoms. While Adderall is classified as a stimulant and works with both dopamine and norepinephrine, Qelbree is not a stimulant and only works with norepinephrine. Adderall is a controlled substance due to the possibility of abuse, dependence, and overdose. Qelbree is not a controlled substance and has no reports of abuse or overdose. Qelbree dosage must be adjusted when starting or stopping, which is different from the severe psychological dependence that may be seen with Adderall. Qelbree and Adderall interact with some of the same medications but also have different interactions.^{1, 2}

Are Qelbree & Strattera the Same?

Qelbree and Strattera are both non-stimulant, non-controlled medications used to treat ADHD. They work with the same chemicals in the brain and have similar side effects. Qelbree is newer, only comes in Brand name (no generic), and is only dosed once daily. Strattera has a generic and can be dosed up to twice daily. Both Qelbree and Strattera have Boxed Warnings (the FDA’s most prominent warning) for an increased risk of suicidal thoughts and actions in children and adolescents with ADHD. Qelbree and Strattera have major drug interactions with monoamine oxidase inhibitor (MAOI) antidepressants. Qelbree also interacts with CYP1A2 metabolized medications in the liver (e.g. clozapine), while Strattera interacts with CYP2D6 (e.g. amitriptyline).^{1, 3}

What Is Qelbree Used to Treat?

Qelbree is FDA-approved to treat ADHD. FDA approval is granted when a medication has been studied in large research trials against a placebo and proven a clinical benefit. A placebo is a substance that has no therapeutic effect, used as a control in testing new drugs. Qelbree is dosed at a maximum of 400 mg daily for children and 600 mg daily for adults. Since Qelbree has only been approved for a few years, there are no current reports of off-label or other uses for Qelbree. Off-label use describes the acceptable medical practice of using a medication for a purpose that has not been studied in research trials.¹

Is Qelbree Used for Weight Loss?

Qelbree has not been studied for weight loss, nor is it prescribed off-label for that purpose. While other drugs that work with norepinephrine, such as Contrave and Qsymia, have been FDA-approved for treating obesity, Qelbree has not been grouped into that category. A small number of children and adults who take Qelbree can expect to experience a decreased appetite. This accounts for small decreases in weight observed in Qelbree patients during research trials. Regardless, Qelbree should not be considered a weight loss drug.^{1, 4, 5}

Side Effects of Qelbree

Qelbree may cause two different types of side effects: those that exist as long as the use of the medication continues and those that are related to the body’s adjustment when starting or stopping the medication and may be temporary.

Patients of all ages may experience things like nausea, sleepiness and headache, abdominal pain, increased heart rate and blood pressure, and insomnia or irritability. Almost all side effects were more frequent in adult patients (max daily dose of 600mg) than in pediatric patients (max daily dose of 400mg). Side effects that are likely to be temporary as the body gets used to the medication include nausea, headaches, and abdominal pain. Side effects like sleepiness, irritability, increased heart rate and blood pressure, or insomnia are more likely to be sustained side effects while taking Qelbree.¹

Common Side Effects of Qelbree

The most common side effects of Qelbree experienced in children were sleepiness, headache, reduced appetite, and nausea/vomiting. The most common side effects experienced by adults were fatigue, insomnia, headache, nausea, and dry mouth. In research trials, the most common reason patients stopped Qelbree was sleepiness or fatigue.

About one-third of all patients taking Qelbree experienced a larger-than-normal increase in their heart rate at some time during their treatment. None of the patients experiencing any of the common side effects required medical attention. Patients should exercise caution when starting or stopping Qelbree and not drive or operate heavy machinery until the drug’s effects have been realized. Use your best judgment and contact a healthcare provider immediately if you believe your side effects are too severe.¹

Common side effects of Qelbree include:*¹

• Increased heart rate or blood pressure
• Decreased appetite
• Insomnia OR fatigue/sleepiness
• Nausea/vomiting
• Headache
• Dry mouth
• Constipation

*All medications, including Qelbree, can cause side effects that can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your provider or pharmacist about any questions you have and understand the potential side effects and benefits of any medication.

Serious Side Effects of Qelbree

Qelbree may cause serious side effects requiring immediate medical attention. In a very small number of patients, Qelbree increased suicidal thoughts and behaviors. This is a serious side effect associated with many drugs that work in the same way that Qelbree does and warrants immediate medical attention. This side effect more commonly occurs in children and adolescents than adults.

Qelbree may potentially cause or worsen manic and hypomanic episodes in individuals with bipolar disorder. Qelbree causes an increase in heart rate and blood pressure in many patients and should be used with caution in patients who have serious pre-existing cardiovascular conditions. Lastly, when combined with MAOIs or other serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), Qelbree may produce a condition called serotonin syndrome, which can be life-threatening. ¹

Serious side effects of Qelbree may* include:¹

• Increased heart rate/blood pressure
• New/worsening suicidal thoughts or behavior
• New/worsening mania/hypomania
• Serotonin syndrome (e.g. abnormal eye movements, fast heartbeat, high blood pressure, hallucinations, increased body temperature, loss of coordination, nausea and vomiting)

*All medications, including Qelbree, can cause side effects that can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your provider or pharmacist about any questions you have and understand the potential side effects and benefits of any medication.

Allergic Reactions to Qelbree

There are no reports of allergic reactions to Qelbree in the research trials used to approve it. Any drug can produce an allergic reaction, which can be serious or life-threatening. Contact a provider or pharmacist immediately if there is a development of rash, hives, itching, or swelling after starting Qelbree. Life-threatening reactions include anaphylaxis, which is a steep drop in blood pressure, and Stevens-Johnson syndrome, which causes the skin to shed. Call 911 immediately if there is swelling of the face, lips, or tongue, or a rash that spreads across the entire body and seems to be peeling.¹

Allergic reactions to Qelbree may include:¹

• Hives
• Rash
• Itching
• Swelling, including of the face, lips, or tongue
• Blistering or skin peeling

If someone experiences allergic reactions to Qelbree, they should immediately seek medical attention. A healthcare professional will assess the severity of the reaction and recommend appropriate treatment. Mild allergies may be treated with antihistamines, such as Benadryl. Severe allergies require hospitalization. It is likely that patients reporting an allergy will be switched to an alternative therapy.

Qelbree Warnings & Precautions

Qelbree may produce sudden and/or severe reactions that require medical attention. Qelbree is contraindicated in patients on monoamine oxidase inhibitors (MAOIs) or sensitive CYP1A2 substrates (e.g. Ambien). This is due to the risk of a high blood pressure crisis and drug interactions.  A doctor or pharmacist should review patient medications before prescribing Qelbree to screen for these interactions.¹

Suicidal thoughts and behaviors are common in patients taking Qelbree for ADHD, particularly in pediatric patients. Close clinical follow-up is necessary, especially during initial therapy and dosage changes. There may be a consideration for modifying treatment if such symptoms emerge. Qelbree can increase heart rate and/or blood pressure and carries the risk of inducing manic or mixed episodes in patients with bipolar disorder. It may also lead to sleepiness, affecting activities requiring mental alertness.

It is vital for patients to stop using Qelbree if allergic reactions occur and promptly consult a healthcare professional. Alternative treatments and monitoring for precursor symptoms of suicidal ideation should be discussed with a medical provider. Cautious monitoring of heart rate, blood pressure, and mental status during Qelbree therapy is advised, especially in patients with bipolar disorder.¹

Precautions for taking Qelbree address:¹

• Taking Qelbree during pregnancy or breastfeeding: Qelbree has not been studied in pregnant or breastfeeding humans, though in animal studies, it led to fetal harm. Qelbree’s presence in human breast milk is uncertain, and its impact on breastfeeding infants and milk production is unknown. Therefore, the decision to use Qelbree during breastfeeding should consider its potential effects on both the mother and the child. Pregnant mothers should register with the Qelbree pregnancy registry.
• Severe kidney and liver impairment: Qelbree levels in the body increase in patients with kidney issues, and Qelbree will significantly impact the breakdown of certain drugs in the liver. Both of these may lead to toxicity. Consult with a pharmacist or doctor if you have severe kidney or liver problems or take other medications.
• Patients with bipolar disorder: Qelbree may cause or worsen manic/hypomanic episodes in patients with bipolar disorder.
• Suicidal thoughts or behaviors: Qelbree may cause or worsen suicidal thoughts or behaviors. Prescribers will monitor patients for these during therapy.

Interactions With Qelbree

4 groups of substances you should avoid while taking Qelbree include:^{1, 6}

• Mental health medications: SSRIs, tricyclic antidepressants (e.g. amitriptyline), MAOIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), and medications for Parkinson’s disease should be used cautiously with Qelbree or avoided. Qelbree, in combination with other drugs that alter brain chemistry, may lead to serotonin syndrome or high blood pressure crises. Call 911 if there is unexplained confusion, agitation, twitching muscles, rigid muscles, or large pupils.
• Certain herbs and supplements: St. John’s wort, tryptophan, and other natural supplements, may contribute to serotonin syndrome.
• CYP1A2-sensitive medications. Taking Qelbree with caffeine, tizanidine, clozapine, olanzapine, ropinirole, verapamil, and propranolol may create an unsafe interaction. Qelbree will increase a patient’s exposure to these medications significantly, which may lead to toxicity.
• Sedative medications: When used with opioids, benzodiazepines, and alcohol, Qelbree may increase the sedation (sleepiness) seen with these medications. Exercise caution when combining use, and do not operate heavy machinery until the effects are realized.

Discuss with a provider if you take these or any other medications. This is not a complete list of drugs that are significantly affected by Qelbree.

Qelbree Dosages for FDA-Approved Treatment

Qelbree dosage for pediatric patients age 6-11 start at 100mg once daily, adjusting weekly up to 400 mg daily, while those aged 12-17 start at 200mg, adjusting to 400mg. Adults begin with 200mg, adjusting weekly to a maximum of 600mg. Patients may take Qelbree with or without food, but capsules must not be cut, crushed, or chewed.

For patients with severe kidney problems, the starting dosage is 100mg once daily and may increase to 200mg. No adjustment is needed for mild to moderate renal problems. Dosage will be periodically reevaluated and adjusted by your provider as necessary to balance symptom control and side effects.¹

Qelbree Forms & Strengths

Qelbree is currently available in extended-release (ER) capsules. These capsules come in dosages of 100 milligrams, 150 milligrams, and 200 milligrams. A provider will choose your starting dose and increase your dose based on your medical history, current symptoms, side effects, and other medications you take. There is no specific data on how long Qelbree may take to achieve effects in every individual, but it can generally be assumed that patients may begin to see symptom improvements in a few weeks, with maximum effect taking up to several months to be noticed.¹

Qelbree is available in the following forms and strengths:¹

• 100mg ER capsule
• 150mg ER capsule
• 200mg ER capsule

How Should I Take Qelbree?

Take Qelbree in the morning, with or without food. Do not cut, chew, or crush the capsules. Patients who cannot swallow capsules may open them and sprinkle the contents onto a spoonful of applesauce or pudding, and consume them within 15 minutes of doing so. Always take medications as directed by your providers.¹

What Happens If I Miss a Dose of Qelbree?

Qelbree should not be stopped, and the dosage should not be adjusted without first consulting your provider. There is no specific data on what to do if you miss a dose of Qelbree. In general, if you remember within 8 hours of missing the dose, you may take the missed dose. If more than 8 hours have passed, skip the dose and resume normal dosing the next day.¹

Can You Become Addicted to Qelbree?

In research trials, there were no reports of psychological dependence, addiction, or abuse of Qelbree. There have been no reports of overdose associated with Qelbree. During the course of normal usage, Qelbree may produce mild physical dependence, which is easily overcome with proper tapering (slowly lowering the dose) at discontinuation. Your pharmacist or provider will give you more information regarding how to start and stop Qelbree appropriately.¹

Can You Overdose on Qelbree?

There have been no reports of overdose associated with Qelbree. Qelbree can cause seizures at high doses, as studied in animals. Any medication can be toxic if consumed in high enough doses. Be mindful of general symptoms of medication toxicity that may be observed with Qelbree, such as persistent or severe nausea and vomiting, extremely elevated heart rate or blood pressure, convulsions, fever, or confusion and agitation.¹

What Should You Do If You Take Too Much Qelbree?

If you have any symptoms of Qelbree toxicity are observed, patients should seek immediate medical care or call 911. There is no known antidote or detoxifying agent for Qelbree. Patients will be treated as their individual symptoms require.¹

Questions to Ask Your Healthcare Provider About Qelbree

Before starting, patients should consult their doctor, psychiatrist, therapist, or pharmacist to discuss Qelbree’s suitability based on medical history, any family history of bipolar disorder or depression, and potential risks or benefits. They can inquire about dosing based on age or other medications, monitoring parameters like heart rate and blood pressure, and possible side effects, including suicidal thoughts or actions. If considering a change in prescriber, online psychiatry services can offer a convenient option for patients seeking a provider who can guide them through Qelbree’s use and adjustments.

Questions to ask your care team about Qelbree include:

• How long will it take for me to adjust to taking Qelbree?
• When will I know that Qelbree has achieved maximum benefit for me?
• Am I at risk for more serious symptoms if I am already taking medication treatments for other mental health disorders?
• What is the best dosage to ensure few side effects? And how does it compare to other medications, such as the side effects of Qsymia?
• Is there anything I should tell my therapist about this new medication?
• Are you comfortable prescribing Qelbree to me if I become pregnant?
• Do I take any medications or supplements that need to be adjusted first?
• How should I start taking Qelbree?
• How should I proceed if I want to stop Qelbree?
• Are there discounts or coupons for Qelbree to save money on my prescription?
• How does Qelbree compare to Strattera for treating ADHD?

In My Experience

In my experience, Qelbree is a good option if you are unable to tolerate the side effects of stimulant medications for ADHD. It’s important to talk to your provider and pharmacist about Qelbree if you are interested in trying this medication. One thing to consider is insurance coverage and the cost of this medication. Your insurance may require you to try less expensive medications for ADHD before they decide to pay for Qelbree since it is brand name only at this time. Be sure to follow your pharmacist and prescriber’s instructions on how to carefully start and stop this medication to prevent any unwanted side effects.