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Qelbree 200mg (highest single-capsule strength; also supplied as 100mg and 150mg - no 400mg capsule exists) Capsule
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Indications & Clinical Uses
- Qelbree (viloxazine extended-release capsules), a non-stimulant selective norepinephrine reuptake inhibitor, is FDA-approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and in children and adolescents aged 6 to 17 years.
- It is taken once daily by mouth, with or without food, and is not a controlled substance, unlike many stimulant ADHD medicines.
- Qelbree is manufactured as 100 mg, 150 mg and 200 mg extended-release capsules - there is no single 400 mg capsule; the maximum recommended daily dose is built from these capsule strengths (up to 400 mg/day in children aged 6-17, and up to 600 mg/day in adults).
- Capsules can be swallowed whole or opened and sprinkled on soft food for people who have difficulty swallowing.
Side Effects
- In children, the most common reactions (at least 5% of patients, roughly twice the placebo rate) are sleepiness, decreased appetite, fatigue, nausea, vomiting, insomnia and irritability; in adults, insomnia, headache, sleepiness, fatigue, nausea, decreased appetite, dry mouth and constipation are most common.
- QELBREE CARRIES A BOXED WARNING: clinical studies found higher rates of suicidal thoughts and behaviour in people with ADHD treated with Qelbree than with placebo, so close monitoring for worsening mood or new suicidal thoughts is required, especially in the first few months of treatment or after a dose change.
- Increases in blood pressure and heart rate can also occur - report chest pain, palpitations, or any new or worsening low mood, agitation or suicidal thoughts to a healthcare provider promptly.
Precautions & Warnings
- Qelbree is contraindicated with current or recent use of a monoamine oxidase inhibitor (MAOI), including within 14 days of stopping one, because of the risk of a hypertensive crisis, and should not be combined with sensitive or narrow-therapeutic-range CYP1A2 substrate medicines.
- Blood pressure and heart rate should be measured before starting and periodically during treatment, since both can rise.
- All patients should be screened for bipolar disorder before starting, as Qelbree can trigger manic or hypomanic episodes in susceptible people.
- Because it can cause sleepiness and fatigue, caution is advised when driving or operating machinery until the individual effect is known.
- Safety in pregnancy and breastfeeding has not been fully established; discuss with your healthcare provider before starting or continuing treatment.
Avoid Interactions
- Qelbree must never be combined with a monoamine oxidase inhibitor (MAOI), either during use or within 14 days of stopping either medicine, because of the risk of a serious hypertensive reaction.
- It should not be used with sensitive CYP1A2 substrate drugs, and combining it with moderate CYP1A2 substrates is not recommended, as dose reduction of the other medicine may otherwise be needed - examples include certain antipsychotics and theophylline, so check with a pharmacist.
- Qelbree is also partly broken down by CYP2D6 and CYP3A4 pathways, so medicines that strongly affect these enzymes may need monitoring for increased side effects.
- Tell your healthcare provider about all prescription and over-the-counter medicines, herbal products and supplements you take, including other ADHD or mood medicines, before starting treatment.
References
Frequently Asked Questions
Qelbree (viloxazine) treats attention-deficit/hyperactivity disorder (ADHD) in adults and in children and teens aged 6 to 17. It's a non-stimulant, taken once daily, and isn't a controlled substance like many other ADHD medicines. It acts on norepinephrine pathways in the brain to improve attention and reduce hyperactivity.
Qelbree extended-release capsules are taken once daily by mouth, with or without food. Swallow whole, or open the capsule and sprinkle the contents on soft food if swallowing is difficult. Capsules come in 100 mg, 150 mg and 200 mg strengths - there's no single 400 mg capsule.
Common effects include sleepiness, tiredness, decreased appetite, nausea and insomnia. Qelbree carries a boxed warning for higher rates of suicidal thoughts and behaviour in people with ADHD compared with placebo. Seek urgent help for any new or worsening low mood, agitation or suicidal thoughts, especially early in treatment.
Never combine Qelbree with an MAOI antidepressant, or start one within 14 days of stopping Qelbree - this combination can cause a dangerous rise in blood pressure. Tell your prescriber about all other medicines, since Qelbree can raise levels of some CYP1A2-processed drugs like theophylline.
Take the missed Qelbree dose as soon as you remember that day; if it's close to your next dose, skip the missed one and continue your normal once-daily schedule. Don't take two doses at once. Store capsules at room temperature, 20°C to 25°C (68-77°F).
Yes, Qelbree is approved for children and adolescents aged 6 to 17, as well as adults, for ADHD. The maximum dose is 400 mg once daily in children and 600 mg once daily in adults, built from the 100 mg, 150 mg and 200 mg capsules.
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