This article was last updated/ edited on April 6, 2023.
Viloxazine extended-release (Qelbree®) is a selective norepinephrine reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults.
Viloxazine immediate-release has been used in many European countries since 1974 as an antidepressant but, after having been available for about 30 years, was removed from the market by the manufacturer “for business reasons” (Findling et al., 2021).
Here is basic information about this medication. Links to other articles on this website with more advanced information and tips related to this medication and related topics are provided below—under Related Pages below.
(Optional to read: While the drug was being developed, in published literature it was called SPN-812.)
Viloxazine is generally similar to atomoxetine (brand name Strattera®), which has been available in the United States for a long time as a treatment for ADHD.
FDA-approved indications
Treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 to 17 years of age.
Pharmacodynamics
Viloxazine binds to the norepinephrine transporter and inhibits the reuptake of norepinephrine by the norepinephrine transporter (Findling et al., 2021), which is what atomoxetine (Strattera®) does as well.
The FDA-approved Prescribing Information refers to viloxazine as a “selective norepinephrine reuptake inhibitor”. But, like many other medications, viloxazine seems to have some additional pharmacological effects (Yu et al., 2020), though it is not clear whether and to what extent they are relevant to its clinical benefits.
Optional to read:
In laboratory assays done by the manufacturer, viloxazine was found to have (Yu et al., 2020):
– Antagonistic activity at 5-HT2B receptors
– Agonist activity at 5-HT2C receptors.
It was also found to increase extracellular serotonin levels in the prefrontal cortex (Yu et al., 2020).
Boxed warning
(Emphasis in red, below, was added by us)
“In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo.”
Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.”
Adverse effects
Common adverse effects (defined as occurring in 5% or more of patients AND at least twice as often as on placebo)and two times the rate of placebo): somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.
Serious adverse effects: Suicidal thoughts and behaviors, increase in heart rate and blood pressure, activation of mania or hypomania, and increased somnolence and fatigue.
Assessment of heart rate and blood pressure is recommended by the Prescribing Information—before starting viloxazine, after increasing the dose, and then periodically.
Contraindications
1. With an MAOI or within 14 days after stopping an MAOI.
2. With sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range since viloxazine is a strong CYP1A2 inhibitor. Use of the following medications is contraindicated along with viloxazine: alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline.
Drug interactions
Viloxazine is a strong CYP1A2 inhibitor.
Avoid using CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range with viloxazine.
Dosage
Viloxazine extended-release capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce
a) Age 6 to 11 years
Starting dose: 100 mg once daily
Titration: Increase 100 mg weekly
Maximum: 400 mg once daily
b) Age 12 to 17 years
Starting dose: 200 mg once daily
Titration: Increase 200 mg after 1 week
Maximum: 400 mg once daily
c) Adults
Recommended starting dose: 200 mg/day
Depending on response and tolerability, the dose may be increased in increments of 200 mg per week to the maximum recommended dosage of 600 mg/day.
Special situation: Severe renal impairment
Starting dose: 100 mg once daily (instead of 200 mg/day)
Titration: Increase weekly by 50 to 100 mg/day
Maximum: 200 mg once daily (instead of 600 mg/day)
Dosage forms and strengths
Extended-release capsules: 100 mg, 150 mg, 200 mg
Cost
A one-month supply—30 capsules of viloxazine extended-release (Qelbree®) 200 mg—costs about $330. But the full dose for adults is 600 mg/day and the highest strength in which the medication is available is 200 mg. So, at the full adult dose of 600 mg/day, a one-month supply costs about $980 (source: Goodrx).
In comparison, for atomoxetine (Strattera®), a one-month supply—30 capsules of 100 mg each— costs about $33 (source: Goodrx.com).
Important! Please refer to Prescribing Information (see link below) for a complete discussion of dosage, administration, warnings and precautions, contraindications, etc.
Prescribing information for viloxazine extended-release capsules (Qelbree®)
Related Pages
Atomoxetine (Strattera®): Basic Information
Don’t ignore atomoxetine for ADHD in adults
Order genetic testing for a patient on atomoxetine?
Seizure risk if atomoxetine and bupropion are used together?
Combine a stimulant and atomoxetine?
It makes a big difference—atomoxetine once a day or twice a day?
What can we do for somnolence/ sedation on atomoxetine?
References
Prescribing Information
Prescribing information for viloxazine extended-release capsules (Qelbree®)
Review articles
Cutler AJ, Mattingly GW, Jain R, O’Neal W. Current and future nonstimulants in the treatment of pediatric ADHD: monoamine reuptake inhibitors, receptor modulators, and multimodal agents. CNS Spectr. 2020 Oct 30:1-9. doi: 10.1017/S1092852920001984. Epub ahead of print. PMID: 33121553.
Findling RL, Candler SA, Nasser AF, Schwabe S, Yu C, Garcia-Olivares J, O’Neal W, Newcorn JH. Viloxazine in the Management of CNS Disorders: A Historical Overview and Current Status. CNS Drugs. 2021 Jun;35(6):643-653. doi: 10.1007/s40263-021-00825-w. Epub 2021 May 18. PMID: 34003459; PMCID: PMC8219567.
Goodell K, Erlich D. Viloxazine (Qelbree) for ADHD. Am Fam Physician. 2023 Mar;107(3):309-310. PMID: 36920832.
Other references
Faison SL, Fry N, Adewole T, Odebo O, Schwabe S, Wang Z, Maletic V, Nasser A. Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Methylphenidate in Healthy Adults. Clin Drug Investig. 2021 Feb;41(2):149-159. doi: 10.1007/s40261-020-00992-6. Epub 2020 Dec 23. PMID: 33368026; PMCID: PMC7886742.
Faison SL, Fry N, Adewole T, Odebo O, Wang Z, Maletic V, Nasser A. Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Lisdexamfetamine in Healthy Adults. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):155-162. doi: 10.1097/JCP.0000000000001361. PMID: 33587403; PMCID: PMC7919699.
Nasser A, Faison SL, Liranso T, Adewole T, Busse GD, Fava M, Kleiman RB, Schwabe S. Evaluation of the Effect of SPN-812 (Viloxazine Extended-Release) on QTc Interval in Healthy Adults. J Clin Psychiatry. 2020 Oct 13;81(6):20m13395. doi: 10.4088/JCP.20m13395. PMID: 33049804.
Yu C. Metabolism and in vitro drug-drug interaction assessment of viloxazine. Xenobiotica. 2020 Nov;50(11):1285-1300. doi: 10.1080/00498254.2020.1767319. Epub 2020 Jun 10. PMID: 32394778.
Yu C, Garcia-Olivares J, Candler S, Schwabe S, Maletic V. New Insights into the Mechanism of Action of Viloxazine: Serotonin and Norepinephrine Modulating Properties. J Exp Pharmacol. 2020 Aug 25;12:285-300. doi: 10.2147/JEP.S256586. PMID: 32943948; PMCID: PMC7473988.
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