Medications Directory

Approved indications: Qelbree (viloxazine extended-release) is FDA-approved as a once-daily non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD) in adults and in pediatric patients 6 years and older.

Off-label uses: In the United States, there are no widely accepted, well-studied off-label indications for Qelbree beyond ADHD; clinicians mainly use it within its approved indication, for example when stimulants are not tolerated, are ineffective, or are not appropriate because of tics, substance-use risk, or other concerns.

Efficacy expectations and onset: Many people begin to notice some improvement in attention, impulsivity, and hyperactivity within 1–2 weeks of starting or increasing the dose, with full benefit often seen after 4–6 weeks on a stable dose; clinical trials show statistically significant but moderate improvements in ADHD rating-scale scores compared with placebo.

Typical clinical outcomes: Qelbree can reduce core ADHD symptoms throughout the day and improve functioning at school, work, and home; some patients experience substantial benefit, while others see only partial improvement or require dose adjustments or combination with other treatments.

Comparison to other ADHD medications: As a non-stimulant and non-controlled substance, Qelbree tends to have a slower onset and somewhat smaller average effect size than stimulant medications, but its efficacy is comparable to other non-stimulants such as atomoxetine, and it offers an option for patients who prefer or require a non-stimulant approach.

Typical dosing by age: For children 6–11 years, the usual starting dose is 100 mg by mouth once daily, which may be increased by 100 mg each week up to a maximum of 400 mg once daily; for adolescents 12–17 years, the usual starting dose is 200 mg once daily, which may be increased after 1 week to 400 mg once daily if needed; for adults, the starting dose is 200 mg once daily, which may be increased in 200 mg weekly steps up to a maximum of 600 mg once daily, depending on response and tolerability.

Kidney and liver considerations: In people with severe renal (kidney) impairment, treatment generally starts at 100 mg once daily and can be titrated in 50–100 mg weekly increments up to a maximum of 200 mg once daily; use is not recommended in significant hepatic (liver) impairment, and clinicians may use extra caution and monitoring if liver disease is present.

How and when to take it: Qelbree is taken once daily at about the same time each day, either in the morning or evening, depending on whether it tends to cause sleepiness or insomnia for the individual; it can be taken with or without food.

Capsule handling and sprinkling: Capsules should not be cut, crushed, or chewed; they may be swallowed whole, or opened and the entire contents sprinkled onto a spoonful of applesauce or pudding, swallowed without chewing.

Sprinkled-dose instructions: When sprinkled, the mixture must be taken completely and promptly (within about 2 hours for applesauce or 15 minutes for pudding), and should not be stored for later use.

Special dosing instructions: Dose adjustments are typically made no more often than once per week to allow time to assess benefit and side effects; clinicians may continue Qelbree long term if it remains effective and well tolerated, with periodic re-evaluation of the ongoing need for medication.

Missed-dose guidance: If a dose is missed, it should be taken as soon as remembered unless it is close to the time of the next scheduled dose, in which case the missed dose should be skipped and the regular schedule resumed; two doses should not be taken on the same day to make up for a missed one.

Overdose: Taking more than prescribed can cause pronounced drowsiness, slowed reflexes, and a fast heart rate, among other symptoms; emergency medical help, 911, or a poison control center (1-800-222-1222 in the U.S.) should be contacted immediately if an overdose is suspected.

Common side effects: The most frequently reported side effects include sleepiness or fatigue, decreased appetite, nausea or vomiting, stomach discomfort, trouble sleeping (insomnia), headache, irritability, dry mouth, and constipation; these occur in roughly 5–20% of patients, often within the first days to weeks, and are usually mild to moderate.

Course and management of common effects: Sleepiness and fatigue may improve by adjusting the time of day the dose is taken; decreased appetite can lead to small weight loss, so children’s weight and growth should be monitored; nausea often improves if the medicine is taken with food or after the stomach has settled, and persistent insomnia or headaches should be discussed with the prescriber for possible dose or timing changes.

Serious or rare adverse effects requiring immediate medical attention: New or worsening suicidal thoughts or behaviors, severe mood or behavior changes (such as agitation, aggression, or sudden mania), chest pain, a fast or pounding heartbeat, markedly increased blood pressure, signs of an allergic reaction (such as rash, swelling of face or throat, or trouble breathing), or signs of liver problems (such as dark urine, persistent nausea, severe fatigue, or yellowing of skin or eyes) need urgent medical evaluation.

Warnings and precautions: Qelbree carries a boxed warning for increased risk of suicidal thoughts and behaviors in children and adults, especially during the first few months of treatment or after dose changes; it can raise heart rate and blood pressure, so these should be checked before starting, after dose increases, and periodically thereafter.

Special populations: Use is not established in children under 6 years; lower maximum doses are required in people with severe kidney impairment, and use is generally not recommended in significant liver disease; in pregnancy, data are limited and many experts advise avoiding or discontinuing Qelbree unless benefits clearly outweigh risks, and breastfeeding decisions should weigh low but present drug transfer into milk against the benefits of treatment, with infant monitoring for excessive sleepiness or feeding problems.

Safety compared with other ADHD drugs: Qelbree is not a controlled substance and has shown no evidence of abuse or withdrawal in clinical trials, which can be an advantage over stimulant medications, but it still has important psychiatric and cardiovascular warnings and can cause bothersome sedation or insomnia in some patients.

How to report side effects: Side effects can be reported to the FDA MedWatch program (online or by calling 1-800-FDA-1088) or to the manufacturer, and patients should also tell their prescriber about any concerning or persistent adverse effects.

Major prescription-drug interactions: Qelbree must not be used with monoamine oxidase inhibitors (MAOIs) or within 14 days of taking an MAOI because of the risk of dangerous blood pressure increases; it is also contraindicated with sensitive CYP1A2 substrates or those with a narrow therapeutic range, such as theophylline, tizanidine, duloxetine, alosetron, ramelteon, and tasimelteon, because Qelbree can markedly raise their blood levels.

Other prescription interactions to consider: Caution is needed when combining Qelbree with stimulants, SNRIs, some antidepressants, or other medicines that raise heart rate or blood pressure, as well as with sedating drugs (such as benzodiazepines, opioids, or certain sleep medicines), because of additive cardiovascular or central nervous system effects; the prescriber may adjust doses, increase monitoring, or avoid certain combinations.

OTC medicines, supplements, and foods: Decongestants that contain pseudoephedrine or phenylephrine, large amounts of caffeine (including energy drinks), and herbal products that affect mood or drug metabolism (such as St. John’s wort) may increase side effects like elevated blood pressure, heart rate, anxiety, or insomnia, so they should be used cautiously and only after checking with a clinician; there are no specific food restrictions, and Qelbree can be taken with or without meals.

Alcohol and recreational substances: Alcohol and other sedating or mood-altering substances can increase dizziness, sleepiness, impaired judgment, and mood changes while taking Qelbree, and may worsen side effects or reduce treatment benefit, so limiting or avoiding them is recommended.

Diagnostic and imaging procedures: Qelbree has no known direct interactions with imaging contrast agents or routine diagnostic tests, but all current medications should be disclosed to healthcare professionals before procedures, especially if sedation, anesthesia, or agents that affect heart rate or blood pressure will be used.

Key precautions and populations requiring extra care: Qelbree should be used cautiously and with close monitoring in people with a history of suicidal thoughts or behaviors, depression, bipolar disorder or mania, significant cardiovascular disease, uncontrolled hypertension, serious kidney impairment, or liver disease, and in pregnant or breastfeeding individuals; it is not established or recommended for children under 6 years of age.

Monitoring needs: Before starting Qelbree, clinicians typically review personal and family psychiatric history and measure blood pressure and heart rate, then recheck these after dose increases and periodically during treatment; children and adolescents should also have weight (and often height) monitored, and all patients should be observed for changes in mood, behavior, sleep, or signs of suicidal thinking, with kidney and liver tests considered when underlying disease or concerning symptoms are present.

Q: How long does Qelbree take to start working?
A: Some people notice improvements in focus or impulsivity within 1–2 weeks, but it can take 4–6 weeks at a stable dose to see full benefit, so ongoing follow-up with the prescriber is important.

Q: Is Qelbree a stimulant or a controlled substance?
A: Qelbree is a non-stimulant selective norepinephrine reuptake inhibitor and is not a controlled substance, and it has shown no evidence of abuse or dependence in clinical studies.

Q: What time of day should I take Qelbree?
A: It can be taken once daily in the morning or evening, at the same time each day; if it causes daytime sleepiness, some people do better taking it at night, while if it causes trouble sleeping, morning dosing may work better.

Q: Can Qelbree be taken with stimulant ADHD medications?
A: Qelbree is sometimes combined with stimulant medicines when a single medication does not provide enough symptom control, but this should only be done under a prescriber’s supervision because of additive effects on heart rate, blood pressure, and sleep.

Q: What should I do if I miss a dose of Qelbree?
A: If you miss a dose, take it as soon as you remember unless it is close to the next scheduled dose; if it is close, skip the missed dose and take the next one at the regular time, and do not take two doses in one day.

Q: Will Qelbree affect my weight or appetite?
A: Qelbree can decrease appetite and lead to small weight loss in some people, especially children, so appetite, weight, and growth should be monitored and any significant changes discussed with the prescriber.

Storage: Store Qelbree capsules at room temperature (about 68–77°F / 20–25°C), protected from moisture and heat, in the original container with the lid tightly closed, and keep out of reach of children and pets.

Disposal: When capsules are expired or no longer needed, use a drug take-back program if available (often through pharmacies or local law enforcement), or follow local guidance for home disposal.

Home disposal steps (if take-back is not available):

• Remove the capsules from their bottle and mix them with something undesirable such as used coffee grounds, dirt, or cat litter.
• Place the mixture in a sealed bag or container and throw it in the household trash; remove or black out personal information on the prescription label before discarding the empty container.
• Do not flush Qelbree down the toilet unless specifically instructed by local authorities.