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Dr. Malhotra:
Hello and welcome. My name is Dr. Atul Malhotra. This session is entitled Experts Debate: How Novel Excessive Daytime Sleepiness Treatments Fit Into Clinical Practice for Obstructive Sleep Apnea. I’m the Research Chief for Pulmonary Critical Care, Sleep Medicine, and Physiology at University of California, San Diego, and I'm a Professor of Medicine here doing research on patient care related to sleep disorders and other conditions. I’d like to introduce my friend, Dr. Neomi Shah.
Dr. Shah:
Thanks, Atul. My name is Neomi Shah, and I’m at the Icahn School of Medicine at Mount Sinai in New York City. I'm a Professor of Medicine and Vice Chair of Medicine for Faculty Affairs.
Dr. Malhotra:
Great. Thank you. So Neomi, this question is about patients who are on Modafinil. And can you tell me a little bit about your experience in terms of side effects and tolerance and efficacy and everything on Modafinil?
Dr. Shah:
Yeah, absolutely. And so for obstructive sleep apnea, we've been using Modafinil as sort of as the primary go-to for residual excessive daytime sleepiness. And overall, it's very well tolerated. I think the main sort of side effect that I hear from patients is a headache. That's the most common one. And in that case, we usually sort of come down in the dose a little bit. So instead of the 200, I'll come down 100. And then if they take it first thing in the morning. Other than that, really any other side effect that have been really observed, including insomnia or anxiety, I haven't really seen that. Most patients are able to tolerate it. And you know, it's out of the system, mostly by the time that they're going to bed, as opposed to armodafinil, that has longer half-life, so that one, you sometimes see that. But it's still rare.
Dr. Malhotra:
Yeah. I've had a couple of surprise babies in my practice where patients on birth control pills or taking Modafinil and didn't realize there was a drug interaction, even though I warned them about it. Have you had that experience as well?
Dr. Shah:
Fortunately, no. I would be interested in finding out how you handled those. But yeah, no, I'm fairly - I'm not saying that you're not, but I'm fairly meticulous about that. And so, you know, I’m very, very like – I make it very clear that it will decrease the efficacy of OCPs. And that ideally, I actually have them, you know, get another mode of contraception that is not interacting with. And so usually they will comply but again, of course, we never know, as your cases demonstrate.
Dr. Malhotra:
Yeah, I’ve often called it a double whammy because it interferes with birth control pills and as teratogenics, so I try to avoid in premenopausal women unless they do have a barrier contraceptive.
Dr. Shah:
Yeah, great point.
Dr. Malhotra:
What about the rash that this patient is experiencing? Is that something you've seen very often?
Dr. Shah:
No. Never seen it. Of course, we worry about it, but I've never seen that.
Dr. Malhotra:
Never seen a rash? Or never seen Stevens-Johnson?
Dr. Shah:
Stevens-Johnson, yeah. Rash, I mean, again, actually, yeah, I don't think any patients have really shown up with a rash. So it's been very well tolerated. The main thing with Modafinil sometimes is that it's not fully effective in terms of resolving sleepiness. So despite giving the 200 in the morning, they still have sleepiness, and that's usually the one thing that I'm tackling, this afternoon dose or switching to another drug.
Dr. Malhotra:
I've certainly seen rash, but I don't think I've seen Stevens-Johnson per se, which is obviously what you're worried about in that class. But when I do see rash, I discontinue the medication and start something different. And as far as I can tell, Modafinil and armodafinil are kind of cross tolerance, so I don’t usually switch from one to the other. What about solriamfetol in terms of how well that's tolerated?
Dr. Shah:
Yes, I have a few patients on solriamfetol. It's pretty well tolerated. I think anxiety, it's sort of the one thing that I've seen in patients that take solriamfetol. Other than that, again, it's pretty well tolerated. Because of the fact that it doesn't interact with oral contraceptives, a lot of women, I favor that drug, especially if they're on OCPs.
Dr. Malhotra:
So as you know, I was involved in some of the clinical trials on this, and so we published a few papers, one on the blood pressure effect, there's a tiny increase in blood pressure, you can sometimes save it, it's, you know, tiny. Now you do see some improvements in body weight, though. So overall, cardiometabolic profile looks better, as a modest effect, but many people that’s a welcome benefit as an off-target effect, so.
Dr. Shah:
Yeah, and the Epworth Sleepiness Scale numbers do look more favorable for solriamfetol compared to the other drugs. So if you truly have someone who's excessively sleepy, and you think that they may not do well on Modafinil, I usually reach for solriamfetol for that purpose.
Dr. Malhotra:
And you mentioned to me at some point, a meta-analysis that was in the Annals of Internal Medicine, can you remind me about that?
Dr. Shah:
Yeah. So I just basically came across that paper where they looked at 14 RCTs, comparing either the drugs, mostly the placebo because there are very few that have had head-to-head comparisons, and essentially solriamfetol emerged as the one that had the highest impact on the Epworth Sleepiness Scale. And also the MWT numbers, solriamfetol and Modafinil were the two that really improved that, pitolisant not really much in terms of MWT. Overall, they were all pretty well tolerated. And so yeah, I just sort of use solriamfetol for that purpose in terms of its impact on the Epworth Sleepiness Scale.
Dr. Malhotra:
I think that's consistent with my clinical practice as well. I see a lot of patients who are failing Modafinil, and perhaps referral bias, but you know, I do see a pretty good efficacy with solriamfetol. I think consistent with the literature is my clinical experience, although it's still early days, as you mentioned.
Hey, thanks, everybody, for joining us today. It's been my pleasure. And thank you Neomi for your insights.
Dr. Shah:
Of course. Thank you.
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