Qelbree® (viloxazine) is the first non‑stimulant drug approved by the FDA specifically for attention‑deficit/hyperactivity disorder (ADHD). Here’s what you need to know about its adult approval:
| Item | Details |
|------|---------|
| FDA approval date for adults | December 15, 2021 (the same approval that covers all patients 6 years and older, so adults ≥ 18 years are included) |
| Indication | Treatment of ADHD in adults (and adolescents, but you’re asking about adults). |
| Dosage for adults | • 50 mg once daily for 30 days
• If tolerated, increase to 100 mg once daily (may raise to 200 mg if needed; maximum 200 mg/d) |
| Form | Oral tablets (50 mg, 100 mg, 150 mg, 200 mg) |
| Mechanism | Selective norepinephrine reuptake inhibitor (NERI). No dopamine reuptake inhibition – different from many stimulants. |
| Key safety points | • Common side effects: insomnia, headache, decreased appetite, dry mouth, fatigue, increased heart rate, and anxiety.
• Serious risks: increased blood pressure/heart rate, mood changes, suicidal thoughts in young adults.
• Avoid in patients with uncontrolled hypertension or tachyarrhythmias. |
| Drug interactions | • CYP2D6 inhibitors (e.g., fluoxetine) can increase viloxazine levels.
• MAOIs, other sympathomimetic drugs, or substances that affect blood pressure may increase cardiovascular effects. |
| Special populations | • Not recommended in pregnancy (Category C).
• Limited data in elderly, but no specific contraindications. |
| Insurance & Cost | Many insurers now cover Qelbree for ADHD. Check your plan; cost can vary from $350–$450/month depending on coverage. |
Quick FAQ
| Question | Answer |
|----------|--------|
| Is Qelbree a stimulant? | No, it’s a non‑stimulant, which can be useful for people who don’t tolerate stimulants or have a history of substance abuse. |
| Can adults take Qelbree if they’re already on stimulants? | Switching from a stimulant or adding Qelbree can be done, but your clinician will monitor blood pressure and heart rate closely. |
| What if I miss a dose? | Take it as soon as you remember, unless it’s almost time for the next dose. Skip the missed dose; don’t double‑take. |
| Will it help with comorbid depression? | Viloxazine is an antidepressant (SSRIs are more common, but it has some antidepressant activity), so it may offer some benefit, but that’s not its primary label indication. |
Bottom line: Qelbree is FDA‑approved for adults with ADHD, approved in late 2021, and is taken once daily with a starting dose that can be titrated up. If you’re considering it, discuss with your prescribing provider to see if it fits your medical profile and treatment plan.