Overview

• Qelbree (viloxazine ER) and Strattera (atomoxetine) are nonstimulant oral medications approved by the FDA to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older.
• They are both classified as selective norepinephrine reuptake inhibitors. They increase levels of norepinephrine (a chemical messenger in the brain) to improve focus, attention and impulsivity in patients with ADHD. Neither drug is classified as a stimulant and they are not federally controlled substances.
• Qelbree is given once per day and Strattera can be given either once or twice daily. Both products come as oral capsules. Strattera is available as generic option, which may help to save you money.
• Common side effects they share include drowsiness, nausea and decreased appetite.

In this article, we'll review Qelbree and Strattera and the differences that might matter to you when deciding on an ADHD treatment.

Attention deficit hyperactivity disorder (ADHD) is a common condition marked by ongoing issues related to attention, hyperactivity, and impulsiveness that can interfere with learning, development and daily functioning. It can occur in school aged children and adolescents and often persists into adulthood. In the U.S., about 9.4% of children and 1% to 5% of adults are estimated to have ADHD.

Table 1: Selective Norepinephrine Reuptake Inhibitors (Nonstimulants for ADHD)

Learn more: Dosing for Qelbree and Dosing for Strattera

How do side effects compare between Qelbree and Strattera?

• Most people tolerate these medicines well. But there are side effects and warnings you should be aware of and discuss with your healthcare provider if you have concerns.
• These medicines work similarly and share the same drug class, but warnings and side effects can be similar or different.
• Always review the Patient Medication Guide for any new information each time you get a prescription filled. Your pharmacist can give you a Medication Guide if you do not have one.

Both Qelbree and Strattera have Boxed Warnings (FDA’s most prominent warning) for an increased risk of suicidal thoughts and actions in children and adolescents with ADHD, especially within the first few months of treatment or when the dose is changed.

• The risk of suicide thoughts is low (less than 1%) and no completed suicides were reported in approval studies.
• However, patients should be carefully monitored, and any new or sudden changes in mood or behavior should be reported right away to your healthcare provider.
• Monitoring should include daily observation by families and caregivers.

There is a very important drug interaction with both of these medicines. You should NOT use either of these medicines if you are taking or have taken within the past 14 days an antidepressant medicine called a monoamine oxidase inhibitor (MAOI). The combination can lead to a variety of serious side effects, including dangerously high blood pressure and even death. If you are not sure if you take an MAOI, ask your pharmacist. MAOIs are not prescribed very often today.

If you or your child have high blood pressure, a heart rate disorder or other heart problems, be sure to tell your doctor before you are treated with either of these medicines.

Let your doctor know if you have a history of bipolar disorder, depression, mania or hypomania before you start treatment with Qelbree or Strattera. In people with untreated bipolar disorder, use of these medicines can lead to mania (an extreme increase in activity, talking, lack of sleep and risk for dangerous behaviors).

Both drugs can also cause drowsiness or fatigue and these are common side effects. Do not drive or operate heavy machinery until you know how the medicine will affect you.

Do not use Strattera if you:

• have an eye problem known as narrow angle glaucoma
• have now, or have had in the past, a rare tumor called pheochromocytoma.

Do not use Qelbree if you:

• take any of these drugs: alosetron (Lotronex), duloxetine (Cymbalta), ramelteon (Rozerem), tasimelteon (Hetlioz), tizanidine (Zanaflex), or theophylline (Theo-24, Elixophyllin).

Warnings and Side Effects

Qelbree warnings include: Suicidal thoughts and behaviors, increases in blood pressure and heart rate, worsening of mania or hypomania (a type of mental health disorder), somnolence and fatigue (drowsiness, tiredness). Patients should be monitored for changes in weight.

In studies, most patients continued Qelbree treatment. About 3% of patients stopped treatment due to a side effect, with somnolence (drowsiness) being the main reason patients stopped therapy.

In clinical trials for Qelbree, the most common side effects included:

• Children / Adolescents: Somnolence (drowsiness), decreased appetite, fatigue, nausea, vomiting, insomnia (trouble sleeping), and irritability.
• Adults: insomnia (trouble sleeping), headache, somnolence, (drowsiness), fatigue, nausea, decreased appetite, dry mouth and constipation.

Strattera

Strattera warnings include: suicidal thoughts and behaviors, severe liver injury, serious cardiovascular events (sudden death, stroke and heart attack), increase in blood pressure and heart rate, allergic reactions, changes in urination, priapism. May cause or worsen aggressive, hostile behavior or certain mental health disorders like mania, bipolar disorder or psychosis. Children should be monitored for changes in weight / height.

Avoid touching a broken or open Strattera capsule. Wash your hands and any surfaces that may have touched an open capsule. If any of the powder gets in your eyes or your child’s eyes, rinse them with water right away and call your doctor.

Serious side effects include: serious allergic reactions (call your doctor if you have trouble breathing, see swelling or hives, or experience other allergic reactions), slowing of growth (height and weight) in children, problems passing urine including, trouble starting or keeping a urine stream, cannot fully empty the bladder.

Priapism (erections that won’t go away) have occurred rarely during treatment with Strattera. If you have an erection lasting longer than 4 hours, seek medical help / call 911 right away.

In studies, 3% of patients stopped Strattera treatment due to side effects. The top reasons treatment was stopped was due to irritability or somnolence (drowsiness) in children and insomnia, nausea, and chest pain in adults.

In clinical trials for Strattera, common side effects include:

• Children / Adolescents: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence (drowsiness, sleepiness).
• Adults: Constipation, dry mouth, nausea, fatigue, decreased appetite, insomnia (trouble sleeping), erectile dysfunction, urinary hesitation and/or urinary retention and/or dysuria (painful urination), dysmenorrhea (painful periods), and hot flush.

This is not a complete list of possible warnings or side effects. Call your doctor for medical advice about side effects.

Which is more effective, Qelbree or Strattera?

Head-to-head, randomized, controlled studies comparing Qelbree with Strattera are not available, so it is not possible to say which one is more effective. They both have been shown to be effective options for treating ADHD in studies when compared to a placebo (a pill with no active ingredient).

Initially, stimulants like Adderall or Ritalin are considered more effective for treating ADHD symptoms than Qelbree or Strattera. Stimulants are typically used as a first-line treatment when possible; however, effectiveness can vary among individuals. Some individuals may have better results with the nonstimulants or tolerate them better.

In Phase 3, placebo controlled clinical studies, both Qelbree and Strattera have been shown to be effective in the treatment of ADHD in adults and children 6 years of age and older. Selection of one product over the other may depend upon your preference or that of your healthcare provider, considering side effects, dosage and cost.

• For children under 6 years of age, Parent Training in Behavior Management (PTBM) and / or behavioral classroom interventions are the first line of treatment.
• The use of medications, with or without psychosocial interventions like PTMB, are the first-line therapy for school-aged children (6 years and older) and adolescents diagnosed with ADHD.
• Stimulants are typically the first drug-of-choice for treatment of ADHD in children 6 years and older and adults. Stimulants, like methylphenidate (Ritalin) or mixed amphetamine salts (Adderall, Mydayis) are considered more effective for treating ADHD symptoms than the nonstimulants.

However, nonstimulants like Qelbree or Strattera may be preferred agents for treatment of ADHD in patients who have or live in households where substance abuse is a concern. They may also be preferred for children with tics, Tourettes or who have had previous severe side effects with stimulants.

Other nonstimulant medications for ADHD include the alpha²-agonists clonidine extended-release (Kapvay and generics) and guanfacine extended-release (Intuniv and generics), but they are also less effective than stimulants for first-line treatment.

Can I get addicted to Qelbree or Strattera?

These medicine have not been reported to be habit-forming or cause withdrawal symptoms or dependence.

Qelbree or Strattera are not controlled substances. They are nonstimulant medications and are alternatives to immediate-release stimulant medications (for example, Ritalin or Adderall) for people with substance abuse concerns or that cannot tolerate stimulant side effects.

How do drug interactions compare between these agents?

Both Qelbree and Strattera have the potential for significant drug interactions because they affect cytochrome (CYP) P450 enzymes in the liver that may change blood levels of drugs in your body. This could lead to an increased risk of side effects. In some cases, your doctor may need to adjust your doses of medications or select an alternative treatment.

Be sure your doctor or pharmacist screens for drug interactions with any medicines you take, including prescription, over-the-counter, vitamins, and herbal or other dietary supplements. Do not start or stop any new medicine during treatment without first talking to your healthcare provider. Your doctor can decide if it is safe for you to combine medicines.

DO NOT USE Qelbree or Strattera with monoamine oxidase inhibitors (MAOIs), or within 2 weeks after stopping MAOIs. Combined use may lead to side effects that could be deadly.

• MAOIs are an older class of drug used to treat severe depression and other mental health disorders.
• MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Qelbree

Qelbree (viloxazine) is a strong CYP1A2 inhibitor. You should not use this medicine with certain other medicines that are CYP1A2 substrates, because blood levels of those medicines may increase and cause side effects. Tell your doctor if you or your child take: MAOIs, alosetron, duloxetine, ramelteon, tasimelteon, tizanidine or theophylline.

Qelbree is also a weak inhibitor of CYP2D6 and CYP3A4 and may lead to increases in blood levels of drugs that depend upon these enzymes for breakdown and excretion in the body.
Your doctor or pharmacist can screen for these possible drug interactions. Your doctor can monitor you for side effects or adjust doses if needed.

Strattera

Tell your doctor if you are or child take any antidepressants, asthma medication, blood pressure medicine, or cold or allergy medicine that contains a decongestant (such as pseudoephedrine or phenylephrine). or blood pressure.

Dose adjustments may be needed if Strattera (atomoxetine) is used with potent CYP2D6 inhibitors or if used in patients known to be CYP2D6 poor metabolizers.

Use of Strattera with CYP2D6 inhibitors (for example: paroxetine, fluoxetine, and quinidine) may significantly increase atomoxetine blood levels in some patients (extensive metabolizers). Increased Strattera blood levels can occur, and may lead to side effects such as dizziness, dry mouth, loss of appetite, sleep disturbances, and heart palpitations.

Bottom Line

• Qelbree and Strattera are both oral nonstimulant medicines shown in clinical studies to be effective in treating ADHD in children 6 years and older and adults. They are not stimulants (like Ritalin or Adderall) and are not controlled substances.
• Both medicines are given once per day. Alternatively, Strattera may be given as a divided dose twice a day. The Qelbree capsule can be opened and sprinkled on applesauce or pudding and taken immediately for patients who have trouble swallowing the capsule.
• Strattera is available as a generic option, but Qelbree is only available as a brand name product at this time, which makes it more expensive. Insurance is more likely to pay for atomoxetine due to the generic availability.

This is not all the information you need to know about Qelbree (viloxazine) or Strattera (atomoxetine) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.