Qelbree (viloxazine) for adults with ADHD

Viloxazine, sold as Qelbree, is the newer of the two non-stimulants whose FDA labels cover ADHD in adults. It was first approved for children in 2021, and the adult indication followed in April 2022. Its most important practical feature for adults is a strong effect on a liver enzyme, CYP1A2, which rules out several common medicines. This page summarizes the current FDA label (published on DailyMed in October 2026) in plain language. It is not advice to start, stop or change any medication.

What viloxazine is and how it works

The label describes Qelbree as a selective norepinephrine reuptake inhibitor indicated for ADHD "in adults and pediatric patients 6 years and older." Adult use is on-label.

In plain terms, it slows the clearing of norepinephrine, a brain messenger involved in attention, by blocking its transporter. The label says the mechanism in ADHD "is unclear" but thought to work this way, and adds that viloxazine also acts on a serotonin receptor (5-HT2C) as a partial agonist. It is not a stimulant, and the label lists no controlled substance schedule for it.

The adult approval

The FDA approved the adult indication on April 29, 2022 (supplement S-003 to NDA 211964). The approval letter states that Qelbree "is now indicated for the treatment of ADHD in adults and pediatric patients 6 years and older."

The evidence for adults rests on one trial described in the label: a six-week, randomized, double-blind, placebo-controlled, flexible-dose study of 374 adults aged 18 to 65. Symptom scores fell more with viloxazine than with placebo on the investigator-rated scale, and overall severity ratings improved more as well. A single short trial is a thinner evidence base than exists for atomoxetine or the stimulants, which is worth knowing when you weigh options.

At a glance

Drugs@FDA lists Qelbree as the only marketed viloxazine product. A generic viloxazine application from another company is listed with "tentative approval," which means it cannot be sold yet. Cost questions are covered in ADHD medication cost in New York.

The boxed warning

Unlike atomoxetine, whose boxed warning is written about children, Qelbree's boxed warning covers all patients: "higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo." In the adult trial, 3 of 189 adults on viloxazine (1.6%) reported suicidal ideation on a standard rating scale, compared with none of 183 on placebo. No adults in either group reported suicidal behavior, and no suicide attempts occurred.

The label also says to screen for a personal or family history of suicide, bipolar disorder and depression before starting, and notes that insomnia and irritability were more common on the drug. If thoughts of self-harm appear, contact the prescriber the same day. In a crisis, call or text 988.

The CYP1A2 interaction, explained

The label calls viloxazine "a strong CYP1A2 inhibitor." CYP1A2 is a liver enzyme that breaks down certain drugs. When it is blocked, those drugs build up. For that reason, Qelbree is contraindicated with sensitive CYP1A2 substrates or those with a narrow therapeutic range. The patient Medication Guide names:

• alosetron
• duloxetine
• ramelteon
• tasimelteon
• tizanidine
• theophylline

The label adds that moderate sensitive CYP1A2 substrates are not recommended alongside it, and that viloxazine weakly inhibits CYP2D6 and CYP3A4, so levels of drugs cleared by those enzymes may rise. Bring a complete medication list, including sleep aids and muscle relaxants, to the visit. A broader list is in ADHD medication drug interactions.

Who should not take it

• Anyone taking an MAOI or within 14 days of stopping one, because of the risk of a hypertensive crisis
• Anyone taking a sensitive or narrow-therapeutic-range CYP1A2 substrate, such as those listed above

Other warnings

• Heart rate and blood pressure. Viloxazine can raise heart rate and diastolic blood pressure. The label asks for both to be checked before starting, after dose increases and periodically.
• Mania or hypomania. Patients should be screened for bipolar disorder first.
• Sleepiness and fatigue. In adults, somnolence was reported in 6% on viloxazine versus 2% on placebo, and fatigue in 12% versus 3%. The label advises against driving or operating hazardous machinery until you know how it affects you.

Common side effects in adults

In the adult trial, the most common reactions (at least 5% and at least twice the placebo rate) were insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth and constipation. About 9% of adults on viloxazine stopped because of side effects, most often fatigue, insomnia, constipation or headache.

Pregnancy and breastfeeding

The pregnancy section is stricter than for many ADHD medicines. Based on animal studies, the label says viloxazine may cause maternal harm and advises stopping it when pregnancy is recognized unless the benefits outweigh the risk. A pregnancy registry exists. For breastfeeding, a lactation study in 15 women found viloxazine in breast milk at low levels, with no data on effects in the infant. The NIH LactMed database has an entry for viloxazine. Planning around pregnancy is covered in ADHD medication, pregnancy and the postpartum period.

Where it fits

A 2024 review in American Family Physician lists viloxazine, atomoxetine and bupropion as options for adults who are unable to take stimulants or who have concurrent anxiety or depression. How it compares with atomoxetine specifically is in Strattera vs Qelbree, and the broader trade-offs are in stimulant vs nonstimulant ADHD medication.

New York and New Jersey rules

Because viloxazine is not a controlled substance, the Schedule II rules that apply to stimulants do not apply to it: New York's supply and refill limits under 10 NYCRR 80.67, New Jersey's in-person visit requirements for Schedule II stimulants started by telehealth (P.L.2026, c.40) and the DEA telemedicine rules for controlled medications. Those rules are explained in New York's rules for ADHD stimulant prescriptions and New Jersey's rules.

Questions to ask your prescriber

• Do I take anything that interacts through CYP1A2, CYP2D6 or CYP3A4?
• Why viloxazine rather than atomoxetine or a stimulant for me?
• How will we track blood pressure, heart rate, mood and sleep?
• What should I do if I plan to become pregnant?
• What will it cost on my plan, and is prior authorization needed?

Dr. Shershow evaluates adults for ADHD and, when medication is appropriate, discusses stimulant and non-stimulant options as part of a treatment plan. See adult ADHD treatment for how care works.