Peter L. Salgo, MD: I heard a number—there is a 29 minute improvement in sleep time with suvorexant—but the numbers I heard from you guys earlier were much smaller than that. Twenty-nine minutes sounds big to me, yes?
Sanford H. Auerbach, MD: I would have given it 20 minutes.
Karl Doghramji, MD: Yes, 20 minutes.
Sanford H. Auerbach, MD: I think you said a little less.
Karl Doghramji, MD: Twenty minutes, yeah.
Sanford H. Auerbach, MD: So 29 minutes is not that far off. It depends on where the patients start out. How little are they sleeping at night? How severe is the sleep problem? I think Nicole’s point is very good that so far, it’s a poster, and maybe it is something that’s going to turn out to be a wonderful option for these patients. In theory, it doesn’t have the gait disorder. In theory, we wouldn’t necessarily see as much of the cognitive impact. But it remains to be seen in these larger scale studies.
Peter L. Salgo, MD: Are there other studies out there working on this right now?
Sanford H. Auerbach, MD: For this particular agent?
Peter L. Salgo, MD: For any agent. Suvorexant in specific, do you know of any more?
Nicole Brandt, PharmD, MBA, BCPP, CGP, FASCP: I think this is the newest agent on the market. There are other things in different clinical trial stages. But I think for something that’s on the market looking at certain patient populations, I’m not aware of any.
Peter L. Salgo, MD: Are there other drugs as well? This is a group of people in whom better sleep would be really nice. Are there any out there?
Sanford H. Auerbach, MD: Usually my sense is that most of the studies wind up having negative results: why the drugs should not be used in the elderly, particularly the elderly demented patient population. There are lots of data about the negatives of these drugs, but it’s not like there’s much showing that the drugs that can be beneficial without having adverse effects.
Nicole Brandt, PharmD, MBA, BCPP, CGP, FASCP: I want to follow up on that because I think what we stated at the beginning that this treatment improves the quality and function of care, and burden on the caregiver. I think these are things that we need to look at in studies, especially when we’re caring for older adults that might be different than the measurements that we’re typically using in these studies. My hope for the future as we design more clinical trials, is to look at meaningful measurements. I think what matters to older adults isn’t necessarily these minutes, but it’s that next day and the quality of life. I think that would be an impactful study to look at as well.
Peter L. Salgo, MD: The minutes are a metric, right?
Nicole Brandt, PharmD, MBA, BCPP, CGP, FASCP: Yes.
Peter L. Salgo, MD: Which is getting at what you were referring to: that you feel better or don’t feel better; the next day is good or the next day is not so good. Maybe the minutes are simply an avatar for that, no?
Sanford H. Auerbach, MD: An avatar in the sense of being away to measure it?
Peter L. Salgo, MD: Yes.
Sanford H. Auerbach, MD: If you have 29 minutes, that’s good in terms of quality of life during the day and impact on the caregiver? Maybe that might turn out to be the case. But that hasn’t been demonstrated. I think that we’re still stuck—the newer the medication, the less evidence gets to stack up against it. So the case of the suvorexant: it’s the new guy on the block and there are fewer treatments going against it now. I think Karl brought up the point that these “Z-drugs” were thought to be wonderful drugs—safe, for many years. And now these are cautions. Every year it seems like the FDA comes out with greater and greater cautions for us.
Gary L. Johnson, MD, MS, MBA: I think this is one area where the quality of life is very important. You hear a lot of times people saying, “We don’t really care about quality of life. Just show us the hard, clinical endpoints.” But I think this is really the opposite of what we’re looking for because I can foresee situations where somebody may have 29 more minutes of sleep objectively, but they still feel crappy, and vice versa. They may not change at all in the number of extra minutes they get of sleep, but they feel better. Which is more important? I would argue that it’s the quality of life.
Peter L. Salgo, MD: This goes back to what I was asking. Maybe minutes aren’t a bad avatar.
Sanford H. Auerbach, MD: You mentioned trazodone as a very commonly used medication. It’s very common I’ll see somebody who’s been started on the trazodone for their sleep problem by their primary care doctor, and they were so obsessed about their sleep and how bad it was for them and so forth. So they come in and I ask, “Well, you’re on this trazodone, how’s it working for you?” And they say, “Oh, it’s great, I sleep through the night.” And I said, “Well, before you started taking the trazodone, how’d you feel the next morning?” And they said, “Terrible.” Well, now you’re taking the trazodone, you’re sleeping, how do you feel the next morning? They said, “Ugh, terrible.” Because now they were probably dealing with the hangover effect from the medication. But because they were so focused with the minutes of sleep they were getting, it got them off track. I try to point out to them: why take the medicine if there’s no benefit the next day.
Peter L. Salgo, MD: And what do they say when you say that?
Sanford H. Auerbach, MD: “Oh?” But you know, patients, they get in certain grooves. Part of being the clinician is to try to educate them about that, point it out to them. I think they oftentimes take the lead of the physician in terms of citing, “Yes, you’re right, it is the number of minutes that’s the key.”
Peter L. Salgo, MD: Well, what I’m hearing again is that this is a field that, I don’t mean this word as a pejorative, it’s really fuzzy. Because if you look for an objective number like minutes, you’re telling me maybe the minutes aren’t so important, maybe it’s whether you’re feeling better or not in the morning, and maybe that’s not your sleep at all. And maybe we’re treating the wrong thing if we’re going after minutes. And we want to make you feel better for some other reason. What is a clinician to do with all of this? How do you manage your day?
Sanford H. Auerbach, MD: They should do a fellowship in sleep medicine. We’re recruiting right now.
Peter L. Salgo, MD: Wait a minute, you are the dons of sleep medicine, and you’re fuzzy. If I did my fellowship with you, would I come out clearer than you guys?
Sanford H. Auerbach, MD: Well, I think it sounds clearer, and the problem is that not all insomniacs are the same.
Peter L. Salgo, MD: OK.
Sanford H. Auerbach, MD: And I think that you want a clear-cut paradigm for this, you’re a surgeon.
Peter L. Salgo, MD: I’m a physicist.
Sanford H. Auerbach, MD: You just want to see where the lines are. For most patients, there are many things going on at the same time and you have to factor all of those in, and that’s why it’s so complicated. That’s why it’s so hard to study this, because you can look at one piece of it, you could look at the degree of anxiety, you look at the degree of pain—but in fact, in the end patients have a couple of those factors, maybe 2 or 3 or 4 of those.
Peter L. Salgo, MD: My respect for you is mounting by the moment because you’re dealing with a difficult problem with multiple causes in older individuals who have multiple comorbidities. And you’re managing to make them feel better. That’s tough, guys, nice job.
Sanford H. Auerbach, MD: Well said.
Peter L. Salgo, MD: I can’t do that. I want something simple. You’ve got a bug, I’m going to give you an antibiotic, see you tomorrow. In the meantime, you’re paying for all of this.
Karl Doghramji, MD: You know, Peter, could I say something?
Peter L. Salgo, MD: Yes, please.
Karl Doghramji, MD: We started the program by saying that insomnia is a subjective dissatisfaction with sleep. And you asked me if it is subjective and I said, “Yes, it’s all a subjective disorder, defined subjectively.” It’s not the sleep quantity that defines insomnia, it’s the dissatisfaction with sleep. And if you can improve the patient’s level of satisfaction with their sleep, I think you’ve done a lot to help them with insomnia.
Gary L. Johnson, MD, MS, MBA: And the buzz word for that is patient reported outcomes, PRO.
Peter L. Salgo, MD: But you know, what I’ve also heard is that you’ve got to recognize that sometimes it’s not the sleep. Sometimes they come to you complaining that they can’t sleep, and they want to feel better by making their sleep better. And you’ve got to parse out whether it’s the sleep or something else, and that’s tough.
Karl Doghramji, MD: Such as their sense of well-being during the day.
Peter L. Salgo, MD: Right. And then you’ve got to have him pay for everything. They come to you and they say, “Please pay, we want to do this.” Do you go and say, “You’ve got to do step therapy,” or not? It depends on the plan, right?
Gary L. Johnson, MD, MS, MBA: It depends on the plan, it depends on the cost of the drugs if we’re talking about drugs. Yes, it depends on a lot of things.
Peter L. Salgo, MD: Now, there’s something I heard called a niche contract. What the heck is that?
Gary L. Johnson, MD, MS, MBA: I saw that in the outline, and I don’t know what that means. I don’t do contracting.
Peter L. Salgo, MD: I’m so glad somebody else is ignorant.
Gary L. Johnson, MD, MS, MBA: I don’t know what that means either—niche contracting. Do you know?
Peter L. Salgo, MD: Do you know anything about this?
Nicole Brandt, PharmD, MBA, BCPP, CGP, FASCP: No.
Peter L. Salgo, MD: Or is it simply that you’re going to pick specific groups, and those are the groups that you think will do better with specific therapies? Maybe that’s what it is.
Gary L. Johnson, MD, MS, MBA: I don’t know.
Peter L. Salgo, MD: Do you have silos of people that look like they’re going to do better on drug A or drug B or drug C?
Gary L. Johnson, MD, MS, MBA: Well, that’s the nirvana, that’s what we wish we always had is segregating groups of patients, whether it’s treating cancer or treating insomnia. We want to know which patients respond to which drugs. But we usually don’t get that.