Debra Davis, CRNP

Wendy L. Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP:

 We’re going to wrap this up. If you could leave 1 parting bit of advice for our colleagues, our APRNs [advanced practice registered nurses], our physician assistants, the nursing staff that are listening, what advice do you have about managing sleep disorders?

 I loved the part where we talked about the chicken or the egg. When someone comes to you and can’t control their blood pressure, or they’re talking to you about the stress in their life, I think if you always have that tickler in the back of your brain that says, "Are they sleeping? Should I ask if they are sleeping?” I think that that would just go a long way to helping the population to be healthier and having a good night of restorative rest.

Wendy L. Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP: 

And my parting advice to all of our colleagues is don’t be afraid to open Pandora’s box and ask about sleep because you’re going to struggle in getting their pain under control, in treating their depression and anxiety, if we’re not addressing part of the underlying issue, which is not being able to sleep and not getting that restorative sleep. Remember, oftentimes, these people have suffered from sleep issues for years, and you can really make a difference, not just in the short term, but in their long-term health outcomes.

Debbie, it’s truly been my pleasure to sit here and have a dialogue with you about insomnia. It’s been really fun, and I want to thank you on behalf of myself and our colleagues for joining me.

Thank you, Wendy. I have really enjoyed it, and I have learned a lot in preparing for this talk. I just want to move forward in treating our patients as best we can. I’ve learned a lot from you as well. Thank you for your time.

Right back at you. Thank you so much. And to those of you who are joining us, goodbye for now.

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Advanced practice practitioners share final pearls with their colleagues for the management of sleep disorders.

Advice for Advanced Practice Providers in Managing Sleep Disorders

We’ve just got a couple of questions left that I want to ask you. What do you think are the remaining unmet needs out there for people with insomnia?

That they’re not bringing it up when they come in. I think that so many times they think it’s just not important or, often, especially in my world of hormones, patients want a more natural option, and so they think if they mention it, I’m just going to give them a drug for that. And I think that they don’t want that; they just want to try to work through it themselves. I think that that’s a problem.

Other times maybe you’ve got a list of 4 other things that you want to talk about that you think are more pressing, and maybe you think that I won’t think it’s very important, but I do. I think that a lot of times the problem is today’s rushed visit, even though I always try to sit down and really answer your questions. Often it gets put on the back burner, and patients just think it’s not as important.

I think for years there have been medicines out there that will put people to sleep or help them stay asleep, but the risks of those medicines, oftentimes, in my opinion, outweigh the benefits.

So, moving forward, I think that continuing to see that medication development for these people who are suffering is key. We’re not asking people who don’t sleep 1 night in their lives to take medicine; we’re talking about people who for 10 years have suffered with 3 nights or longer of insomnia, whether it’s difficulty falling or staying asleep. And we now have medicines that are safer and that can be used long term, and I think that we need to just continue to move forward as a country in trying to develop those products, to give options to people who truly suffer from chronic insomnia.

I agree 100 percent. I think that if they only knew that this was safe and a very good option, they would be willing to try it. And I think that our colleagues would be willing to prescribe it if they only knew that the DORAs [dual orexin receptor antagonists] really are just orexin inhibitors—they’re not hypnotics, they’re not sedatives, they’re not going to do harm to your patient. But because they’re in this “controlled” box, a lot of times prescribers are like, "Well, no, I’d rather give them something that is not a controlled substance," when in this case, the controlled substance is much safer.

Dr Wendy Wright and Debra Davis comment on unmet needs in insomnia and other sleep disorders.

Unmet Needs in Management of Sleep Disorders

We’ve talked, and we’ve given our colleagues a lot of different options for medicines. We’ve talked about the benefits of all the different medicines and some of the adverse effects, etc. But here’s my question to you as we’re wrapping up our discussion today, how do you determine efficacy in insomnia? What do you use to determine efficacy, if anything?

What a good question, and the honest truth is, and I probably should be a little embarrassed about this, is the patient report. I don’t have an IDSIQ [Insomnia Daytime Symptoms and Impacts Questionnaire]; I don’t have a scoring system. Now, I do that on hormones, because so many times when you bring someone to normalcy, they say, “I’m no better.” I say, “Oh really, you’re still having hot flashes and night sweats?” “No, I haven’t had that since you put me on medicine.” “Really, you’re not sleeping at night?” “No, I sleep just fine.” When somebody feels normal, they’re like, “I’m no better,” and so in my world a lot of times I really do rely on that, “How are you feeling? Are you feeling better? Are you sleeping better?” When really, it probably should be a bit more of a scoring system, of pointing out to them, “Remember, you were only sleeping 4 to 6 hours, and now you’re sleeping 7 to 8 hours.” Because so many times when people feel normal, they’re like, “Well, I don’t know. I don’t think I’m better,” when really, you’re a lot better.

Absolutely. I don’t use a real scoring tool either, I just ask, “Do you feel like it’s helped you? In what way? How long is it taking you to fall asleep? How much longer are you asleep in the middle of the night?” But what I also have asked people to do is, I’ll say to them, “If 10 was the worst you’ve ever thought your sleep was, and you had to rate your sleep today, where are you? With 0 being the best sleep you envision.” And that gives me a sense of, if they say, “I was a 10, and I’m a 5 now,” I say to them, “That sounds like a 50% improvement. Let’s see what we can do tweak that.” Which brings us to our next question, when would you change treatments? What would provoke you? What would be the instigator for you to change a treatment?

Often with the DORAs [dual orexin receptor antagonists] especially, they are supposed to take them every night. If someone says, like when the suvorexant first came out and people were like, “This did not work for me at all.” Then, I’m going to have to make some changes. But if they’re 50% better, I often will pull up a scale and show them that this really improves over time, to stay with it, keep doing the same things. And we always do talk about, “What are you doing before you go to bed at night? Are you watching TV? Are you looking at your phone?” Because remember, the light shuts off melatonin, you need to have a time before bed where you’re not engaging in being on your phone, having that light in your eyes, you really do need a dark room. “What are you doing to prepare for sleep?”

I agree with you, and I would add that for me, what would cause me to change my treatment would be some of those complex sleep behaviors, right? Or if they were reporting sleep paralysis, where they feel like they can’t move when they wake up, or hypnopompic, hypnagogic hallucinations, if they’re seeing things as they’re falling asleep or as they’re waking. Some adverse event, or if they say to me, “I slept through my baby crying.” Those are all reasons that I would switch, and obviously, if they’re not working, then I would move to a different agent.

I want to talk for a moment about adherence to our treatment regimen, and you just mentioned something, Debbie, where you said we really want people taking the DORAs every night. Now, you said that, but historically, we’ve said, “Oh, we don’t want people on sleep medications every night.” So, I think as we’re getting newer options that are safer, our philosophy on how we treat sleep is evolving. Would you agree?

I would agree completely because you would never take your antihypertensive medication every 3 days, or just when you felt like you needed it. You need to take this drug as it’s prescribed, and it’s prescribed for nightly use, because it shows that it really does get better over time. And if you stick with it, and you want to take it properly, take it every night, and I think you’ll find that it gets better and better. You were saying that sometimes people have really adverse events. At what moment, or time, do you say, “Hey, it’s time for you to see a sleep specialist,” and how does that happen?

Certainly, once we’ve diagnosed them with sleep apnea, we will get them in to see a nurse practitioner specializing in sleep so she can titrate up their CPAP [continuous positive airway pressure] machine. If I’m concerned regarding narcolepsy, if I’ve tried the standard of care and these folks are not getting better. If the sleep study was inconclusive, and maybe they need an in-house sleep study. Those are some of the reasons that I send people over for sleep medicine. Does that seem similar to what you’re doing for sleep medicine?

Yes, it is, especially I like what you said about the inconclusive studies, because sometimes it’s, is this mild, or is this moderate, or was it done properly because it was done in the home? Then referring them out I think is a much better idea at that juncture.

As we talk about adherence to the regimen, and you talked about the fact that it’s important people take this once a night, there are different kinds of tools out there. I wanted to share with you a couple of tools we have in our clinic. We now have a bidirectional interface with a patient’s pharmacy. So I click on this cute little button, it’s called “fill history” in our EHR [electronic health record], and I can see any drug the patient has filled at a pharmacy. And if it hasn’t been prescribed by my clinic, it’s in a bold category, so I know someone else is prescribing it. What that helps me to do is drug-to-drug interactions checks, but I can also say, “Look, I’m seeing here that you last filled this drug 6 months ago. Are you still taking it? What’s going on?” Are there other tools that you have for tracking adherence?

We have the same option in our EMR [electronic medical record] system, which is great, because you can, like you said, see drug-to-drug interactions and find out what else they’re taking. Because so many times, patients will say, “No, I haven’t had it filled, but I have plenty.” I can say, “You should not have plenty; how is that you have plenty?” And so, that is a way to bring up the conversation of, “You really should.” I hate to

people, but “I would really like it if you tried taking this every night because it would work better, you would sleep better, and you would feel better.”

Advanced practice practitioners discuss how they assess treatment response and patient adherence in insomnia, and considerations for changing treatment.

Assessing Response to Insomnia Treatment

The newest one on the market is the drug called daridorexant. Because it’s so new, and it was approved in May of 2022 by the FDA, let’s spend a bit of time talking about this trial and the trial to get it approved. I’m going to summarize and then I’m hoping you and I can have a bit of a conversation about it. They did 2 blinded placebo-controlled trials. They were 12-week trials. There was even an extension trial for an additional 40 weeks to assess for safety. But you brought this up, they also assessed for tolerance and withdrawal symptoms, is that correct in that extension trial?

Then they studied 3 different dosages at 10, 25, and 50 mg. The 10 mg was not FDA approved, so what our colleagues have available out on the market today is 25 and 50 mg. Is that correct so far?

That is correct, and what I liked in talking about this drug and looking at this study, is so many times patients will come to us, and they’ll say, “I’m very sensitive, you need to prescribe to me the lowest dose.” Not really. In the study, a lot of times 25 mg did not meet the goal of staying asleep longer. It did well, it did better than the placebo, but not as good as the 50-mg dose did. The company will tell you there is no starting dose, you can start at 25 mg or you can start at 50 mg. But if you want your patient to be successful, you want to start at the 50-mg dose. Of course, there’s always the problem if someone has liver disease or is on one of the other medications that are contraindicated, then you’ll start at the 25-mg dose, but 50 mg should be the dose. It is the dose in the study that showed the most efficacy.

I struggle with that, having prescribed this a fair amount as well, because it goes against the grain of me as an NP [nurse practitioner]. We’ve all been taught to start low, go slow. But when you look at the adverse events in the clinical trials, the 50 mg really wasn’t any higher than the 25 mg yet the 50 mg showed statistical significance in all 3 of the metrics, which was time to fall asleep, as well as the time awake after sleep onset. We call that WASO [wakefulness after sleep onset]. Then it also looked at total sleep time. What I loved about this was it wasn’t polysomnography; it was patient reported. So not only did we see the objective data that you talked about and how important that is, but we also saw that patients felt like they slept an additional almost 1 hour in the middle of the night, and that was their perception.

I thought that was so important that the patients were happy with the drug, and they were happy that they got that extra hour of sleep because in the study when you look at it, these people were sleeping less than 5 hours. For somebody to get to that 6-to-7-hour mark and never having been there in 10 years, they feel like they have a new lease on life, and they should.

Absolutely, and we started this tonight by saying we focus so much on nighttime sleep. But I think what we also need to focus on is the daytime metrics. For the first time ever, correct me if I’m wrong, but I haven’t seen this before, in addition to looking at nighttime outcomes, they also looked at daytime. And what they found was that the 50 mg produced a reduction in what’s called the IDSIQ [Insomnia Daytime Symptoms and Impacts Questionnaire] in the sleepiness domain, where they looked at mental energy and physical energy. Essentially, they had a clinically meaningful reduction in their sleepiness score the next day.

What I found so impressive was they made them fill this out every night, so it wasn’t, “How did you sleep last night,” but, “How did you feel today? Were you mentally tired, were you physically tired, were you sleepy?” If you look at me and say, “Are you mentally tired, are you physically tired?” I would say, “Yes, I am. It’s 9 or 10 o’clock at night.” For them to have improved that IDSIQ score, they were looking at a reduction of 4, and for them to have met that mark and have that reduction of 4 points, just by patients telling you what they felt the night after they were judging their day, to me is very impressive.

Absolutely, and the last thing I think we should chat about is that in that 40-week trial, they continued to improve. We didn’t see tolerance here; we saw that their IDSIQ scores held at least, if not improved. So, one could argue, and this is where there’s some discussion in the world of insomnia, when you start helping people to sleep, and they’re filling that sleep bank up because they’re having a successful night every night they go to bed, will that continue to improve their overall mood, their sleepiness moving forward over time? I think we need more studies to show that, but I think this was the first pharmaceutical agent we’ve seen come to market with not only nighttime data but also daytime performance data as well.

It was the first one, and this company came up with the IDSIQ score. I think we should talk a bit about exactly what that was if you want to.

It’s a word that no one knows what it is.

I think it was developed along with some FDA guidance, and it’s been deemed reliable and valid. It was developed with the FDA as a metric to be used to test insomnia medicines in terms of 4 different types of domains.

The word IDSIQ stands for Insomnia Daytime Symptoms and Impacts Questionnaire. It’s a daytime sleepiness score, correct?

It was, “How you are feeling the next day,” and this company developed it, took it to the FDA, and got almost unheard-of FDA approval for this scoring mechanism to rate their own drug, not knowing how it would rate. I’m sure they felt excited about it and thought that it would rate well, but it worked out well for them that they came up with their own scoring system, and then it was found to be very advantageous.

Drs Wendy Wright and Debra Davis provide an overview of phase 3 trial data for the most recently FDA approved DORA, daridorexant, for the treatment of insomnia.

Debra Davis, CRNP

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