This article was last updated/ edited on November 21, 2022.
Viloxazine extended-release (Qelbree™) is a selective norepinephrine reuptake inhibitor. Here is basic information about this medication.
While the drug was being developed, it was referred to as SPN-812.
Viloxazine is similar to atomoxetine (brand name Strattera®), which has been available for a long time as a treatment for ADHD.
Treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years or older.
The approval was based on phase III, placebo-controlled clinical trials, at least two of which have been published at the time of FDA approval (Nasser et al., 2021; Nasser et al., 2020).
Viloxazine binds to the norepinephrine transporter and inhibits the reuptake of norepinephrine
“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.” (emphasis added by us)
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 started viloxazine, after increasing the dose, and then periodically.
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, theophylline.
Viloxazine is a strong CYP1A2 inhibitor. Avoid using CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range with viloxazine.
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
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: Renal impairment
Starting dose: 100 mg once daily
Titration: Increase 50-100 mg weekly
Maximum: 200 mg once daily
Dosage forms and strengths
Extended-release capsules: containing 100 mg, 150 mg, and 200 mg of viloxazine.
Important! Please refer to Prescribing Information (see link below) for a complete discussion of dosage, administration, warnings and precautions, contraindications, etc.
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.
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.
Nasser A, Liranso T, Adewole T, Fry N, Hull JT, Chowdhry F, Busse GD, Cutler AJ, Jones NJ, Findling RL, Schwabe S. A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children. Clin Ther. 2020 Aug;42(8):1452-1466. doi: 10.1016/j.clinthera.2020.05.021. Epub 2020 Jul 25. PMID: 32723670.
Nasser A, Liranso T, Adewole T, Fry N, Hull JT, Chowdhry F, Busse GD, Melyan Z, Cutler AJ, Findling RL, Schwabe S. Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial. Clin Ther. 2021 Mar 6:S0149-2918(21)00054-0. doi: 10.1016/j.clinthera.2021.01.027. Epub ahead of print. PMID: 33750646.
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.
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