Birgit H. Amann, MD, and Greg Mattingly, MD, share strategies for mitigating adverse events with viloxazine in ADHD and its effect on metabolism of drugs.
Theresa R. Cerulli, MD: Are there some strategies you are using in dosing and titration with regard to adverse events perhaps when you have used viloxazine [Qelbree] in kids and adolescents?
Birgit H. Amann, MD: Absolutely. I tell the patients it’s approved to take once a day, so as long as you’re taking it once a day. I tend to have them start it in the evening but if they prefer to start it in the morning, that’s fine. I just let them know that if they do struggle with fatigue or somnolence, tiredness, I don’t want them to not be able to function obviously during the day, but they can modify that timing. So, once a day, anytime a day, I tell them, and I ask them to start with 1 of the bookends more commonly for me in the evening and then adjust accordingly if they need to.
Theresa R. Cerulli, MD: And is somnolence 1 of the more common adverse events you are seeing, and if so, what else might you know from both the data and your clinical practice to warn clinicians to watch for?
Birgit H. Amann, MD: Somnolence, fatigue, decreased appetite—those are the top 3, I believe. But the discontinuation rates in the studies were low, quite low. I believe it was 3% on the Qelbree treated patients as compared to 1% on those on placebo. I have to say in my office utilizing Qelbree it’s not often I have had to stop due to fatigue, and what I have done if they, for example, let’s say an adolescent did 200 mg for a week and then went to 400 mg and then he had difficulty with somnolence, then I have reverted them back to 300 mg. I don’t have samples for that but thankfully at the pharmacy I can get them the 2 150 mg [doses]. So we have been able to do those half stuffs to help them. Very commonly if they do have difficulty with somnolence or fatigue, it does resolve after a short time, 7 to 10 days. So if they are able to work through that we don’t need to make any adjustments.
Greg Mattingly, MD: If I could offer some guidance for maybe some of the clinicians that haven’t got the chance to use viloxazine. There are a couple of unique things about it that you want to keep in mind when you’re using this product. First of all, it’s the first non-stimulant that can be sprinkled. None of our other non-stimulants have that as an availability, so you have patients that don’t like swallowing capsules, that you want to titrate the dose by being able to sprinkle the dose, you can sprinkle it, you take it once daily, any time of day, as Dr Amann had just said. Viloxazine itself is metabolized through [CYP]2D6 [cytochrome P450 CYP2D6] in the liver, so it’s metabolized through 2D6. So, if you have people on 2D6 medicine, remember that’s going to raise your viloxazine dose somewhat. And then viloxazine itself speeds up the metabolism, changes the metabolism of 1A2. So 1A2 you are going to slow medicines that go through 1A2 and 2 common medicines that go through CYP1A2 [cytochrome P450 1A2] that viloxazine will slow their metabolism is both melatonin and caffeine. Those are things you may want to think about. When you’re using viloxazine tell your patients, “Hey, you may not need as much melatonin. You may try to want to go to sleep without melatonin tonight and see how you do. If you are big caffeine drinker, why don’t you cut back on your caffeine a little bit when we first start the viloxazine because it’s going to raise your caffeine levels a little bit if you’re using it along with caffeine.”
So, once daily, you can sprinkle it. It’s metabolized through the liver, and then once again many of you guys have seen a video of 1 of my patients who is in the long-term pediatric trial. It’s a medicine that in this young man’s experience, he came in and he told us at the end of the study, I said, “Tell me what you have seen with this.” And he said, “Dr Mattingly, I used to be the kid in the family that nobody wanted to be around because I would agitate and frustrate everybody, and I was always all over the place and scattered.” And then he gave me a big smile and he goes, “I think what I am proud of stuff now is I think I am a good big brother.” You could see the self-confidence has changed, you can see the self-image changed, and that’s because his ADHD [attention deficit hyperactivity disorder] was getting good and adequately controlled.
Theresa R. Cerulli, MD: You can’t think of a better outcome, Greg, than having someone’s self-esteem improving with a medication, not that we can attribute it to any 1 medication, but in general it’s been what’s so rewarding and working in the field of ADHD that my experience is that it’s a very treatable condition both with pharmacologic and non-pharmacologic interventions and to see lives change with our assistance and all of the folks listening on the line today has just been so rewarding.
Transcript Edited for Clarity