Roger S. McIntyre, MD, FRCPC: When we think about treatment, I mean, we always need to, at the same time, be thinking about side effects. And side effects are part of life. And even placebo has a rate of side effects. In fact, the rate of side effects reported with placebo is on the order of 50[%] to 65%. So, everything has side effects. So, the question that emerges [is], what are the side effects of a treatment like zuranolone? And is this treatment scheduled? [Here in the video interview, Kosicek lets Dr McIntyre know that she is not as familiar with the adverse effects and she asks him to weigh in, and this is where the transcript picks up]. So, you know, some side effects could be a bit of sedation or somnolence, a bit of sleepiness, and some people can get a little sort of difficulty with sort of just coordination or, you know, as a consequence, that can be mild and transient, but it can be apparent. As with many things in psychiatry, you could see GI [gastrointestinal], but it's not that common, quite frankly, gastrointestinal. I think right now there's still discussions taking place with authorities like the DEA [Drug Enforcement Administration] and so on as to what the scheduling will be. But it's a question I often receive because zuranolone is called a PAM. It's a positive allosteric modulator. PAM. I usually think about PAM as the stuff that you put on your frying pan. But PAM, in this context, is different. This is modulating the GABA receptor function. So, what happens is, is that when you give a treatment like zuranolone, it's modulating the GABA system. And we know from history that some of these medications, the PAMs, could be scheduled. So that's something I think people should know. I haven't at least so far heard where things have landed on which category it's in yet. But I think we're waiting to hear back about that. So, something that people should be aware of.

Carmen Kosicek, MSN, PMHNP-BC: So, I think, too, Roger, what's really important to note is if it is a scheduled product, what does that mean for prescribing providers in the field? Well, if you're doing tele[health] at all, the DEA has still kicked down the road the Ryan Haight Act [Ryan Haight Online Pharmacy Consumer Protection Act of 2008] of if people do or don't need to be seen in person first or within a year of having a controlled medication prescribed, that has been parlayed to COVID and that is now slated to be re-evaluated as of November 2023. I personally would be quite surprised at that time of the year when most of the country is under snow or ice, [as we] are surely going to have a change. So, [I] wouldn't be like shocked at all if that is again parlayed into next year. So, again, thinking of that when you're prescribing controlled medications is something to be mindful of, [asking if] they need a visit. How soon do they need a visit if they're a new patient or not a new patient? But, again, we use prescribed and controlled medications all the time and don't even think twice about it, whether it's orexin center products to help with sleep, whether it's stimulants, or benzodiazepines. And we don't even think twice. So, to have the focus be a negative focus on the class schedule, to me, that is really a smokescreen then for the prescriber who really needs more education about the opportunity of how this could help their patients with MDD [major depressive disorder] vs only focusing on the class’s potential scheduling.

Transcript is AI-generated and edited for clarity and readability.