"Integrating Behavioral Therapies and Hypnotic Medications in Insomnia Management" Suzanne M. Bertisch (01/05/2022)

January 16, 2022

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00:00Those people from other institutions as well.
00:03It's almost everybody sleep.
00:05Occasionally we'll have somebody come
00:06in who's interested from psychology or
00:08from neurology or from other disciplines,
00:10so it's pretty diverse group.
00:15Alright, so we're just letting people
00:17in so good afternoon everyone and
00:20welcome back to our spring semester
00:22for Yale Sleep Seminar and I will start
00:25with just a couple of announcements.
00:27First, just to remember that these
00:29seminar lectures are available for CME
00:31credit and that to receive credit,
00:33you just need to text the ID for the lecture
00:36to Yale clouds the money by 3:15 PM today.
00:38So information I had to do that
00:40will show up in the chat as well
00:42as the code will show up later.
00:44Recordings of the lectures are
00:46available in approximately 2 weeks
00:48at the site noted in the chat.
00:50CME credit isn't available for
00:51later viewings and then finally,
00:53if you have questions during the talk,
00:55please use the chat.
00:56We will address these at the end and
00:59I'll moderate so now it is my pleasure
01:01to introduce today's lead seminar.
01:03Speaker, Doctor Suzanne, British doctor.
01:06British is an assistant professor
01:07of medicine and Sleep Medicine
01:09at Harvard Medical School and is
01:11clinical director of Behavioral Sleep
01:12Medicine at Brigham and Women's.
01:14Hospital she received her MD from
01:17State University of New York at
01:19Stony Brook and her MPH from Harvard
01:21School of Public Health.
01:22She subsequently completed her
01:24internship and residency in internal
01:26medicine at Beth Israel.
01:28She went on to do a clinical research
01:30fellowship in the Division for
01:31Research and Education in Complementary
01:33and Integrative Medical Therapies
01:35at Harvard Medical School,
01:36and this was followed by a Sleep
01:38Fellowship at Sleep Health Centers
01:40in Brighton,
01:40followed by a clinical Sleep Medicine
01:42Fellowship in the division of
01:44Pulmonary Critical Care and Sleep
01:46Medicine at Beth Israel.
01:47Doctor Burtis has been on the faculty
01:49at Harvard Medical School since
01:512008 and is currently assistant
01:53professor of Medicine.
01:54She now serves as clinical director of
01:57the Behavioral Sleep Medicine Program
01:58at Brigham and Women's Hospital,
02:00so she has been an active member of
02:02the American Academy of Sleep Medicine,
02:04importantly serving as a committee
02:06member on the behavioral Insomnia
02:08Guideline Task Force,
02:09and she's currently chair of the
02:11Young Investigators Research Forum.
02:13She is an active member of the society.
02:15Behavioral Sleep Medicine has served
02:16as chair of the Education Committee.
02:18And is currently on the Board of Directors.
02:21She also serves on the Sleep and
02:23Respiratory Neurobiology web committee
02:25patient education subgroup for the
02:27ATS and is on the membership committee
02:29of the Sleep Research Society.
02:31She's principal investigator or Co.
02:33Investigator on many active and
02:35diverse projects.
02:3622 numerous really to name for this,
02:38but I'll include some mechanisms
02:40underlying the blood pressure
02:42lowering effect of sleep extension,
02:44inflammation and sleep restriction
02:46and recovery.
02:46The development of a sleep health
02:49intervention for football players.
02:50Sleep disruption and neuronal
02:51dysfunction in early Alzheimer's
02:53disease and evidence based peer
02:55support interventions to promote
02:57PAP use among others.
02:58So we are really fortunate to have
03:00Doctor Burtis join us today to
03:02discuss an important and clinically
03:04relevant topic integrating behavioral
03:06therapies and hypnotic medications.
03:08Insomnia management so
03:10welcome doctor. British.
03:12Thanks so much for that warm introduction
03:15Janet and thanks so much for everybody
03:17for taking time out of your busy day.
03:19I know it's a tough time for all of us.
03:21I appreciate you coming along
03:23and hearing me speak today,
03:25and hopefully this talk will
03:28not just be interesting.
03:30Beauty soporific though actually my
03:32goal is to give you actually real tools
03:34that you can bring to your bedside,
03:35and this topic is very close to both
03:37my research and clinical passions.
03:41So I'm just gonna go ahead and get started
03:44and hopefully everybody can can hear me.
03:47Here I do have some conflicts of
03:49interest through some consultants
03:51that have been mitigated,
03:52and when I referred to any
03:54of the medications by name,
03:56I will note any evidence that it
03:58turns to it or off label indications.
04:01So the learning objectives today.
04:03At first we're going to start
04:05by summarizing the guidelines,
04:06supporting the use and timing of
04:08both behavioral and pharmacological
04:09treatments for insomnia,
04:10so this is really sort of like
04:12the level up part of the talk,
04:13so everybody is on the same page and we
04:15know what I'm referring to buy medications.
04:17Which medications where they fall in as
04:20well as behavioral therapies as well?
04:22And then we're going to get into
04:24a discussion of talking about what
04:26is the literature in terms of using
04:29these strategies in terms of choosing
04:30one strategy over the other and
04:32in terms of timing and sequencing,
04:35that will allow you then to develop
04:37and implement, you know,
04:38evidence based treatment plans for
04:40your patients, but also importantly,
04:42trying to connect both what we
04:44know from the evidence based and
04:47into implementation.
04:47As far as how to bring this information
04:50to the bedside and actually implement
04:52real plans of care for your patients in
04:54the clinic in order to really optimize
04:57their insomnia treatment as best as
04:59possible on mitigating side side effects.
05:02So it's mostly you probably already
05:03know in 2016 was really sort of a a
05:06change in the OR the thought process,
05:08and the way we think about treating
05:09insomnia and the American College
05:11of Physicians again,
05:12which I think all of you know,
05:14is a very large,
05:16prominent Society of internal.
05:17Medicine, which again is my background.
05:20I thought they came out with a a
05:22strong recommendation that all adult
05:24patients received cognitive behavioral
05:26therapy for insomnia as the initial
05:28treatment of chronic insomnia,
05:29and this was very different CBT I
05:32as it's referred to as was around
05:35for several decades.
05:36But this was the first guideline to
05:38really make it prominent and put it
05:40to the top and it and really was a
05:43change in the way we conceptualized
05:45treatments,
05:45and we'll talk about the limitations
05:47of the guidelines.
05:48Later in the talk and and then,
05:50this was followed by a recommendation
05:52that patient clinicians use a
05:54shared decision making approach,
05:56and we'll talk more about what
05:58that actually means,
05:59including a discussion that benefits,
06:01harms and costs for medication.
06:03So really demoting medications
06:04to to second line. You know.
06:07Obviously when these treatments,
06:08these treatments are available,
06:09so this was a a guideline that came
06:12out in 2016 as many do also know,
06:14there are several international
06:16guidelines and other guidelines in the.
06:18American Academy of Risk of Sleep
06:21Medicine in the recent years
06:23also recently updated the there,
06:25the the guideline for behavioral
06:28psychological treatments for
06:29insomnia and then a few years ago,
06:31I believe it's 2017 that the
06:34pharmacological treatment for
06:35insomnia guideline came out.
06:37So this is great in that we have a lot
06:40of evidence supporting both cognitive
06:42behavioral therapy for insomnia in
06:45pharmacological therapy for insomnia.
06:47But the way the but these guidelines
06:49don't address and what we face is
06:50clinicians every day in clinic when
06:52we're treating patient is how do we
06:54actually choose which treatment to use,
06:56right?
06:56We have like these these a lot of
06:59tools in our in our that we can use,
07:01but how do we use those and something
07:03I actually don't like about the the
07:05structure to it and something I think
07:07unfortunately we hear a lot about.
07:09Our field is that it's a lot
07:10of one or the other.
07:11You know we're gonna use from the therapies
07:13or you gonna use behavioral strategies.
07:16And really,
07:17every pharmacol therapy that you
07:18give actually has a behavioral
07:20component that will get into in.
07:22It creates this false dichotomy that I think
07:26actually undermines the knowledge base.
07:28The skill of clinicians,
07:29and does it disservice to the patients.
07:32So hopefully we'll sort of learn more
07:34about the more Gray and white of medicine.
07:37And though you know,
07:38unfortunately,
07:39we don't have.
07:40Large comparative effectiveness data,
07:42which is really what we need.
07:43We have some data and then you know,
07:46there's also just clinical
07:47knowledge and skill and sense that
07:50we can actually implement plans
07:52that we've both of these roles.
07:54Unruly.
07:55Try to tailor the care for the
07:57patients as best as possible,
07:58so to start up again.
07:59What do we actually mean by
08:01behavioral therapies and,
08:02and this is actually important,
08:03so there's several different steps
08:06that comprise behavioral and cognitive
08:08behavioral treatments for insomnia,
08:10so.
08:11Again,
08:11since you I think most of your
08:13actually sleep providers,
08:14you already know this,
08:15so I won't spend too much time on it.
08:17But when we think of,
08:18you know psychological behavioral treatments,
08:21know when we sort of came up that guideline,
08:23these are.
08:23These were really the large
08:25groups of categories,
08:26and there's there's many other types of
08:28behavioral therapies we won't get into,
08:30but these are the ones that are
08:31sort of been around the longest
08:33and have the most evidence.
08:34Think the one,
08:35the one that's probably not mine, not.
08:37Here is some of the mindfulness
08:40mindfulness work as well.
08:41But essentially they're sleep hygiene,
08:43which is a cornerstone button.
08:45Own our guideline.
08:46We actually came out and recommend
08:48using sleep hygiene as a monotherapy
08:51and to clarify the use of sleep.
08:52Hygiene is really a focus on sleep practices.
08:54Healthy sleep practices that serve
08:56as like the the barebone minimum
08:58of what people need to do in
09:00order not to perpetuate insomnia,
09:02but it's probably not effective
09:04enough for most pages.
09:05Patient as a mono treatment.
09:07So the real need of the behavioral therapy,
09:09which we'll talk about,
09:11is really sleep restriction.
09:12Therapy where we reduce the time
09:14people spend in bed to increase sleep,
09:16drive into sort of,
09:17we align that with the circadian
09:19timing as best as we can tell.
09:21Clinically,
09:21stimulus control to reduce the arousal,
09:24the environment,
09:25and then aspects of cognitive therapies,
09:27or restructuring maladaptive
09:30beliefs in their impact on insomnia
09:32and then relaxation training,
09:34which I won't talk much about in this talk.
09:36'cause this hasn't actually been studied,
09:37usually as part of the sequential
09:40studies that we'll talk about, but.
09:42But to note that when I refer to
09:45CBT in this talk CBT I is you know
09:48best studies as a multi component
09:50strategy that actually combines
09:52usually these five components
09:54to in packages together in a
09:56comprehensive standardized program.
09:58So when I refer to CBT it'll be the
10:00package of it and I'll just sort of
10:02denote therapies that may be pulled apart.
10:04Some of the monotherapy.
10:05So again this is CBT,
10:07I is the gold standard and these
10:10are the components of it and
10:12and this is what it says in.
10:13In the guidelines,
10:14right?
10:14This is what we're all supposed to be using,
10:16but as you also allowed know that CBT it
10:19knows is really a supply and demand issue.
10:21So this is a slide that I I I got
10:24from Dan Buysse and and this is
10:26actually from several years ago.
10:28But he actually plotted and estimated
10:30how many people had insomnia disorder,
10:32which was a low estimate of
10:34over 12 million people.
10:35And at the time there are 213
10:37registered CBT I providers.
10:40They were certified of BSM which
10:43left about 60,000 patients.
10:44Per provider per year,
10:46so obviously supply far outstripping
10:49demand and then even on a log scale
10:51you can see how severe you know
10:54the the the supply of providers
10:58is so because of that there's been
11:00a real movement in our field to
11:02develop more accessible options,
11:03so something that we we use in
11:05our clinic here at the Brigham
11:07and Faulkner and that we've done
11:09studies on is looking at brief
11:11behavioral treatment of insomnia.
11:12There's several research studies
11:14looking at single component treatments
11:16and then mobile based apps and
11:19online treatments and and some risk,
11:22which is the first digital FDA
11:24approved treatment for insomnia
11:26that is available digitally.
11:27So we're making a lot of progress
11:29in the field.
11:30Again,
11:31there's always implementation barriers,
11:33but CBT is becoming more readily
11:35available for people so that
11:38that's sort of the land.
11:39The important thing to note is that despite.
11:43You know that CBT is a very
11:45effective strategy.
11:46We do know that you know it doesn't work
11:48for every patient it has access issues.
11:51Just as we talked about,
11:53and even the digital strategies.
11:55You know it's not going to be
11:57appropriate for some patients.
11:58There's still a lot of language,
11:59cultural barriers, cost issues.
12:02That's preventing,
12:03you know, broad spread,
12:05use of digital therapies,
12:06and actually data from one of the
12:09large pivotal trials of shut eye,
12:12which is actually the.
12:13The research version of of some risk which
12:16is actually at FDA approved version.
12:18If you look on this side,
12:19this was a this is one of the larger
12:22trials and they followed patients that
12:24went through that eight to nine week.
12:27Should I program which delivers CBT.
12:29I did therapy so actually delivers
12:31almost all of the components.
12:33For those of you who are not familiar to it,
12:35it showed you know this was the
12:37proportion of non responders.
12:39So people who who did not achieve
12:42a certain level of improvement,
12:44that was.
12:44Predefined usually for insomnia we
12:47identify non responders with people
12:49who don't drop at least seven points
12:51on the ISI scale which is a 28
12:53point scale that's commonly used in.
12:56And an outcome trials of both
12:58behavioral and some pharmacological
13:00therapies for insomnia.
13:01So post treatment in the shadow arm,
13:04which you see in in orange or red about.
13:07You know about half of the
13:09half of the patients.
13:11Responded so about half didn't
13:13respond and obviously many were
13:14nonresponders in the control group,
13:17but as they follow people overtime
13:19at six months and one year you
13:21could still see that about 1/3 of
13:24patients to who were in the CBT I arm.
13:27Like still still did not respond
13:29so so despite even if it was
13:32available for everybody,
13:33you know it's not going to be perfect
13:34and every and it was sort of just don't
13:36know this from you know any medicine?
13:38There's always individual
13:39response and variation.
13:40That's that's just how.
13:41It works,
13:42so this is sort of amplifies,
13:43you know, sort of the need that,
13:44despite CBT being effective,
13:47safer than medications.
13:49You know,
13:49we still need other types of therapies
13:52to tackle the problem of insomnia,
13:54so the good the good news is we have
13:56a lot of different medications to try,
13:58and again,
13:58this is not going to be a talk focusing
14:00on on all the different medications
14:02we have 'cause most of the most of
14:04the research looking at you know,
14:06behavioral versus pharmacological
14:07therapy versus combined that
14:08you'll see is really focused on
14:11this first category which is
14:12the benzodiazepine receptor.
14:14Agonist,
14:14so this is actually here.
14:15I'm sort of lumping together the
14:18traditional benzodiazepine's as
14:20well as the non benzodiazepine
14:22benzodiazepine receptor agonist
14:24like zolpidem zopiclone most of
14:26those are FDA approved.
14:27Not all of them,
14:28and then we also have several
14:29other medications like therapy.
14:31I mean that includes several other
14:34FDA approved medications for insomnia
14:36so melatonin agonist FDA one being
14:39rozerem the the newer do lyrics and
14:42receptor antagonist, so this is there.
14:45Super excellent and recently
14:46approved Lemon Brexit fund have fall
14:49under a sedating antidepressants
14:51with Doxepin at low dose Doxepin.
14:55Having FDA approval for insomnia
14:56and then commonly off label use for
14:59Trazodone and then several other
15:01lesser studies or lesser effective
15:03treatments including antipsychotics,
15:05anti convulsants and over the counter
15:08medications which is predominantly non
15:10selective antihistamines so this is sort
15:12of the smattering of of things we can treat.
15:15Patients with insomnia.
15:16So the point being is that we have
15:19a lot of options and I know what
15:21our fellow struggle struggle with.
15:23Swipe at the Brigham we created
15:25actually insomnia clinic to try to
15:27concentrate some treatment of insomnia
15:29in terms of pharmacological therapy,
15:31but also teaching them how to deliver
15:34behavioral treatments of insomnia.
15:35And you know, like many clinicians,
15:37our fellow sometimes struggle like.
15:39How do I?
15:39How do I think about all these choices?
15:41I have both behaviorally,
15:43but also for medications.
15:45And again,
15:46because we lack data, you know,
15:48unlike the JNC 8 guidelines,
15:50where if you have a
15:51patient with hypertension,
15:51you actually kind of have a sense of
15:53how to treat them and what works best.
15:54We really don't have Rd maps
15:56like that in in slave,
15:57so it's important to really have a solid
16:00foundation of how these medications differ,
16:02how they would work once you,
16:03how to select medications.
16:05Again,
16:05I'm not going to go into that in that talk,
16:07that's a separate carmickle therapy tough.
16:10Or you can read our chapter and
16:12Doctor Krieger's new principles
16:13of practice where we discuss that.
16:17But this is just a little land
16:18for the following discussion
16:19about how to think of it.
16:21So again in the guideline I mentioned before,
16:23this may probably won't come as most
16:25of surprised you being asleep audience.
16:27But you know the the ASM task force for
16:30Franco therapy for insomnia came out
16:32in support of a lot of the business
16:35days that can receptor agonist,
16:37Doxepin,
16:38ramelteon suvorexant and then
16:40we get evidence against.
16:42Again,
16:42not surprising,
16:43but I think many people do
16:45get surprised that.
16:46But Trazadone was actually recommended
16:49against by the in this guideline,
16:52and notably because of the really
16:54the limited evidence on efficacy and
16:56the suggestion from the one actually
16:59primary study that was reviewed
17:01that suggested potential harm.
17:03I mean there there are some other studies
17:05on transitone that weren't included,
17:06but really across the board that the
17:08data supporting that transition alone
17:10is efficacious for the treatment
17:12of insomnia is pretty nonexistent,
17:14so just something to keep in mind when
17:16thinking about developing evidence.
17:18Based practices for patients,
17:20we published a study.
17:21It's it's sort of old data now from 2010,
17:24just showing that.
17:25You know,
17:26among prescription medications
17:27used for insomnia,
17:29that the benzodiazepine receptor agonists
17:32are are still the most commonly used,
17:35but Trazodone is that the second
17:37one was commonly used as well,
17:39and when we swim when participants
17:41were specifically asked about,
17:43did you use a sleep medication?
17:45You know, almost 20% of adults?
17:47the United States said that yes,
17:49and this actually included
17:50over the counter medications,
17:51so meaning that you know a lot of
17:54patients are still turning to pharmacol.
17:56Logical strategies for insomnia 2,
17:59so again, it's important to sort of review.
18:02You know some basic points.
18:04About choosing those medications,
18:06having discussions about over
18:08the medication use, you know,
18:10and getting a full assessment
18:11from the patient.
18:12We also noted that over half
18:13of patients using a hypnotic,
18:15we're taking at least one other
18:17sedative medications such as an opioid
18:20or other type of benzodiazepine,
18:21and about 10% of the sample took three
18:25or more commonly sedating medications,
18:28and you'll see this will come up later
18:30in the talk when we talk about Safety
18:32Council regarding safety for medications.
18:34For insomnia,
18:35and this is more recent data that we we
18:38did here that use a different data set,
18:40but showed that you know
18:42over about the past decade,
18:43this is all pre pandemic.
18:46That president prescriptions have been
18:48increasing and this actually held true
18:50across different doses of of trust that
18:52we looked at lower lower dose trazadone.
18:54Very low dose.
18:55Lower dose in this actually was similar
18:58across age groups and also also noted that.
19:02That over the same period of time that
19:04zoptic prescriptions were actually happened.
19:06Deep decreasing.
19:06So if you see on the
19:08bottom since 2011 to 2018,
19:11the ambient stories open
19:13prescriptions have been decreasing,
19:16while trazadone slightly increasing as well.
19:19So again,
19:19there's sort of been a shift.
19:22That have been occurring because of several
19:24risks that we know about benzodiazepine use,
19:26and I'm focusing mostly on these
19:29because there's a lot of evidence this
19:30sort of been in use for the longest.
19:32These are the medications you'll see
19:33pop up and in the trials that I'll
19:35I'll talk about in a few minutes.
19:37But as we all know,
19:39you know it's important benzodiazepine's
19:42are effective for treating insomnia.
19:45But as we also know, the big carry risk too.
19:47So again, this is sort of,
19:49you know, one or the other.
19:50We know the behavioral treatments
19:51aren't perfect for treating insomnia.
19:53But we know medications also have.
19:56They may be efficacious,
19:57but also care risk factors for again,
19:59it just makes our job a little bit harder.
20:02Thinking about what medication we may choose,
20:05what,
20:05what treatment strategy we should
20:07choose for a patient on what
20:09medication strategy is best,
20:10knowing that we may be able
20:11to treat their insomnia.
20:12But we have to be very aware of the
20:14potential risks that we're introducing.
20:16So for benzodiazapines know
20:17there's several studies that show
20:19that it increased risk of motor
20:21vehicle accidents in the elderly.
20:23It's been associated with hip fractures.
20:26It's it causes anterograde amnesia.
20:30There's some suggestion.
20:31There's limited suggestions that
20:32people build a tolerance from it,
20:34but I sort of have found,
20:35at least in my clinic,
20:36that I I often see a tolerance
20:38for patients which
20:39is different from what's in this study.
20:41And as we all know,
20:42there's been recent black box warning for
20:44the use of these medications as well,
20:46so these are these are real issues to
20:49think about when prescribing hypnotic
20:52medication medications. In detail,
20:54so that's really the first part of the talk.
20:56Pushes to kind of get everyone up to speed
20:58on like what is what is the data show?
21:00What is the guidelines say we should use,
21:03but how do we actually think about using
21:05all of these strategies and therapies?
21:09You know to our advantage?
21:10You know when we're actually
21:11at the bedside with patients,
21:13this is really where the rubber
21:14meets the road.
21:15And how do we think through this?
21:18I've been thinking about, you know,
21:19treatment strategies to providing
21:21really standard of care or evidence
21:24based medicine for insomnia treatment.
21:26You know,
21:27the actual evidence is is one part of it,
21:29and this is something that will
21:30come up again later.
21:31In the talk.
21:32You know there's there's what
21:33the science says to do from,
21:35you know clinical trial data.
21:36But then there's also,
21:37you know,
21:38you know what we're learning is
21:40equally as important or really the
21:42behavioral science aspects of it.
21:44What's acceptable to patients,
21:46what's appropriate for patients?
21:48Will the patients actually?
21:49Use it,
21:49is it something that's feasible
21:51for them and will they?
21:52Will they stick with the work?
21:55So in thinking about choosing,
21:57you know medic roughly like
21:59medications or behave cognitive
22:01behavioral therapy for insomnia.
22:02Unfortunately, there's there's not a
22:04lot of studies that I've compared them,
22:06and I'm going to sort of go through.
22:09You know what we do know from from the
22:11evidence based and then tide in together to,
22:13you know, apply that to patients.
22:15So really, you know, Charles Marin really
22:18is spearheaded a like much of this work.
22:22And there's, you know,
22:23some early studies that are helpful in
22:25thinking about you know which do we choose?
22:28Is this CBT?
22:29I better to get all of these looked at CBT
22:31on this slide versus medications and all of
22:34these studies looked at have benzodiazepines.
22:36Something that works in the
22:37benzo benzodiazepine receptor.
22:41And I think and and so the first
22:43study was by, you know,
22:45led by Charles and in 1999.
22:49And these four studies that I present here,
22:51as you can see here, all small.
22:52So the first is the marine
22:54study and you know,
22:56there are 18 patients with CBT,
22:58I-20 with temazepam and then they
23:00also looked at combined placebo and
23:03then in 2006 there was actually
23:05similar studies that compared.
23:07You know CBT I versus either singular
23:11Med options combine and versus placebo.
23:13And once you can see what they all have
23:16in common is they're not very big.
23:19They're pretty small studies.
23:21And what they also had in common is
23:23that they they all showed a similar
23:26benefit short term between CBT I and
23:28ZOPICLONE and I think this is these
23:30are really important studies for for
23:33behavioral Sleep Medicine people to
23:35show you know that these techniques
23:37work as well as they seem to work as
23:39well as these medications which is important.
23:42But you know these are these
23:44are pretty small studies,
23:45a couple of other things that the
23:48studies observed is that CBT I seemed.
23:50Got to have a longer benefit long
23:52term from 6 to 24 months I will
23:55have to say you know,
23:56someone who's actually reviewed
23:57these studies and they're in there
23:59are a lot of dropouts in studies,
24:01and I don't and I don't.
24:02I don't think this is conclusive,
24:04and the reason why I bring it
24:05up is because this is, I think,
24:06one of the myths that sort of gets
24:08perpetuated and you'll see in later
24:10later studies you know may not provide
24:12the same evidence of support of this.
24:15So I think it's just like it's important to
24:17dispel these messages as our data evolves.
24:20And actually these studies.
24:21Also showed that combining CV2
24:23with medications may have a slight
24:25advantage over single therapy.
24:27Short term, and again,
24:28this is also usually different
24:30from what people say, right?
24:31We usually hear about that
24:33false dichotomy of meds or CBT,
24:35and I've had patients turned down to CBT.
24:37I because they were on the medication,
24:39so I think it's important to to know
24:41these studies and actually know
24:42what they they show in terms of
24:44the benefits and seemingly
24:46equal benefits short term,
24:47but also know what they didn't show
24:49and that you you know you can.
24:50You can still use these medications.
24:52Together and you know,
24:52and then we think about
24:53how to use them together,
24:55so these so these were important
24:56early studies to really put,
24:58I think CBT in the map show that they you
25:01know whereas effective medication short term.
25:04And then, and you know what the
25:07take home message being that either
25:09CBT or one of the benzodiazepine
25:12receptor medications are are actually
25:14reasonable first line approaches.
25:17You know from what we can
25:18tell from this evidence,
25:20then Doctor Marin actually
25:22had a another sort of.
25:25Practice informing studied in
25:272009 and this was a little bit
25:30of a more complicated trial.
25:32Was a smart design which means
25:34that they actually randomize people
25:35multiple times in this study.
25:37So in this study and I'll go through
25:38it in more detail the next side.
25:40But essentially they initially randomized
25:42people and they had about 160 people total,
25:45so half of the people were randomized to CBT.
25:48I and the other half were randomized
25:50to combine treatment, so CBT,
25:52I plus soulpad M and then after six.
25:56Freaks people were re randomized again to
25:59either the treat to either to either though,
26:03and I'll actually go through it on
26:05the next side, 'cause it's easier,
26:07but this this was the study.
26:09So whoops, yes. So here's 160 people.
26:13So 80 were randomized to CBT I
26:16and then they underwent a a second
26:19randomization where they were
26:21re randomized to extended CBT.
26:24I so the CBT I then extended CPT I.
26:27Or CBT are no treatment and those
26:31who received CBT I, plus zolpidem.
26:34Were re randomized to extended CBT.
26:37I so combined followed by CBT I.
26:41Or extending or extending the
26:43combination so those were the
26:45four possibilities and these are.
26:47As you can imagine, are complex trials,
26:49and you can note that you know
26:51towards the end there's there's
26:52fewer people in each subset,
26:53but regardless,
26:54this is really an important larger
26:56study that actually I think has
26:58some important gives us a lot
27:00of information about this common
27:02clinical problem that we see.
27:04So this this is a this figure is
27:06actually showing the proportion
27:08of treatment responders,
27:09so again these are people who achieved.
27:11At least a seven or eight point
27:13reduction of the Insomnia Severity
27:15Index is their outcome,
27:16and these are presented proportion of
27:19patients by the filing initial randomization.
27:23I'm sorry about that.
27:26So over here,
27:27for those two are randomized first
27:29to CBT I so with the first six weeks
27:32of treatment about 60% of patients
27:35responded and this is actually
27:37similar to those that had CBT or
27:39so put them so that the combination
27:42therapy these looked about the
27:44same so you know so see so the the
27:47medication didn't make CBT any worse,
27:48which is sort of the myth that we hear about.
27:51And then when we looked at extended
27:53treatment for the CBT group.
27:54So those in the darker Gray had.
27:57See an extra extended to CBT for
28:00six months versus those with none.
28:03You know it looks like
28:04those with CBT extended.
28:05Did a little bit better but there
28:08were not substantial differences in
28:10long term and those that perceive the
28:13combined treatment initially those
28:15that continue to receive the the
28:18combination there be again seem to
28:20to do to do better and but those who
28:23seem to do the best for those who got
28:25the extend who started the combination.
28:27Therapy was continued for CBT.
28:29I over a period of time again these
28:32start getting out to to smaller
28:34groups and this is similar results
28:36we're seeing with Remitters.
28:37So this is actually the proportion
28:39of patients who by definition
28:41no longer had insomnia.
28:42So there ISI total scores are under 7,
28:45so you can see you know both groups in
28:48the short term did fairly fairly well.
28:50Not much change in the extended CBT group.
28:54Whether they got treatment or no treatment,
28:56but those who received the
28:57initial combination.
28:58Therapy actually seem to do better in
29:01the long term with either extending
29:04this cognitive behavioral therapy.
29:06Or the the medication component so you know,
29:10sort of the take home message that
29:11I see from from these cities?
29:13Is that CBT alone has durable effects.
29:16Though combining and then tapering with
29:18medication seems to have the greatest impact.
29:20So that's sort of getting out here.
29:23Again,
29:23these get it to the smaller groups so
29:26it's again hard to be more conclusive
29:28than all that what that shows.
29:30But this was really one of the first
29:31cities to actually look at this.
29:32The combination of medications
29:35versus CBT CBT.
29:36I alone another interpretation,
29:39you know,
29:40sort of making it as a clinically as
29:42simple as a morsel is that despite
29:44again the myth that you can't
29:45do CBT with medications,
29:47it actually clearly shows that zolpidem
29:49does not impair the response to CBT.
29:51I and actually may.
29:53Augment augment the long term
29:55effects of the medication,
29:56and so again you know there.
29:58There's always a time and
29:59a place for medications,
30:00but this doesn't provide evidence
30:02that the the medication doesn't make
30:04make the response to CBT any worse,
30:06and actually may make it better.
30:08So again,
30:09this was followed up by Charleston,
30:10another study where he has to a
30:13related but different questions.
30:15So the first day was looking at
30:17CBTI versus CBT with medications
30:19as the primary comparison,
30:21and in the more recent study
30:23that was published,
30:24I forget which gym and
30:26network Jim Psychiatry.
30:27In 2020 he actually had the question
30:29of not just one versus the other,
30:32but actually what is.
30:33What do we know about the sequencing
30:35of of medications and CBT?
30:38I so this is another you know for this field,
30:40larger study of over 200 people
30:44and this was you know,
30:45middle aged adults and have
30:46no you know more than
30:47a third had a comorbid psychiatric disorder.
30:50So so very clinically relevant
30:52in terms of the population that
30:54we commonly see with insomnia.
30:56So this again is another complicated smart
30:59design study with a 2 step randomization so.
31:02As the main comparison, they randomized
31:05people to either behavioral therapy.
31:07So this is not CBT.
31:08I this is just behavioral therapy,
31:10mostly stimulus control and sleep
31:12restriction, versus azole epidemic.
31:14Again, I think was like 5 to 1010 milligrams
31:17at the time and then as a second step.
31:20If you receive behavioral therapy
31:23as your first line and continue to
31:25have symptoms so those that were
31:27remission were not re randomized
31:29'cause they no longer had symptoms,
31:31you were re randomized to
31:33medication or cognitive therapy.
31:35So those that had behavioral therapies
31:38were were bumped and didn't respond,
31:40were bumped up to either medication
31:42or cognitive therapy to figure out,
31:44you know,
31:44if you don't respond to behavioral therapy,
31:46what is what's best next?
31:49And similarly,
31:50if you started with the medication
31:52and didn't respond,
31:53your re randomized to behavioral therapy
31:55as a second line or switching from
31:58Zoll Paden to Trazodone medication.
32:01So a complex study will go through the
32:04results and you can see once you start
32:06getting to these these groups down here,
32:08the numbers do get do,
32:09get smaller,
32:10and when they actually power the studies
32:12they actually powered up the order
32:13up here just to keep that in mind.
32:15So this is still the primary
32:17compare comparison up here and
32:18this starts giving us some.
32:20Information about the ordering,
32:21which are really, you know,
32:23they're designed to really answer,
32:24like clinically important,
32:26important questions that we have.
32:29So what did they find in this figure
32:32shows the response and remission rates,
32:34so those are the two different blue
32:36colors for the Firstline strategy.
32:37So again,
32:38this is after the first randomization
32:40of looking at behavioral therapy.
32:42Insulted and and you could see that
32:45the the impact was actually similar in
32:47terms of response rate across groups.
32:49The behavioral therapy.
32:51Had you know, higher remission rate.
32:53But again,
32:55patients did well essentially
32:57have about the same.
32:59The proportion of patients with
33:01improvement were similar across groups.
33:03In the second line of treatment again.
33:08Looking broadly, you could see,
33:10so this is these are these two groups here?
33:12Those who were first randomized
33:15to behavioral treatment and these
33:17who received zolpidem first,
33:19so you could see that those overall those
33:22who receive behavioral therapy first,
33:24no matter what their second line is.
33:27I'm actually continue actually
33:29improves more than those who had
33:32zolpidem as first line response.
33:35So when when patients?
33:38Oh sorry,
33:38this sort of got.
33:43So the the behavioral the the
33:47behavioral therapy nonresponders
33:49did better when when offered you
33:51know another option for second line,
33:53so either medications or cognitive therapy.
33:56Those who receive medication first line.
33:59If the medications didn't work for them,
34:01behavioral therapy was less helpful.
34:03So again, you know this may be similar
34:06to you know you know whether or not
34:09this this is sort of supports the the
34:11ACP guideline of offering cognitive
34:14therapy first is more more helpful,
34:16and I'm not sure really it.
34:17It completely supports that,
34:19but it's it gives you more options if
34:21you have a patient who does a behavioral
34:24therapy first switching them too.
34:26Pharmacological therapy in this case,
34:28so pedem versus adding cognitive therapy.
34:31They seem to improve.
34:32If they didn't respond initially,
34:34whereas if they're on Zhopa damn
34:36initially starting behavioral therapy
34:38or switching them for trazadone didn't
34:40quite have much of an effect as sort
34:43of the the bottom line for this study.
34:45Interestingly, so,
34:46So what I just showed you here is
34:48actually the post assessment period,
34:50and you can see there's you know,
34:51separation of these groups,
34:52so up here is behavioral therapy,
34:54first line,
34:55so this is response rate remission rates.
34:57But then as they followed people
34:59throughout the study.
35:00Again, overtime the groups look the same,
35:03and so you know nihilist would say,
35:04well, it doesn't matter.
35:05You can use any of the combinations,
35:07but I think if someone seeing
35:09patients and thinking about you know
35:11you want your patients to improve
35:12us quickly as possible, you know.
35:15It seems that.
35:17You know the you know the knowing who
35:20actually what your second line options
35:23would be off to get get go may be
35:26helpful but again you know it really.
35:29You could.
35:30People respond equally well
35:31initially to either behavioral
35:33therapy or result the dense.
35:34So again I think it just
35:36it doesn't really steer us,
35:37particularly necessarily One
35:38Direction or the other is sort of,
35:41I think,
35:42supports a diversity of approaches
35:45based on the evidence and and
35:46hopefully we'll have more studies.
35:48But these these head-to-head
35:50comparisons and I think different
35:52combinations of medications and
35:54behavioral strategies as well.
35:56So then moving into sort
35:57of what does this all mean?
35:58So that that's really,
35:59you know, not a lot of evidence,
36:01but that's the data looking at
36:03combinations and and comparing
36:04directly of behavioral medications to
36:07pharmacotherapy medications for insomnia.
36:09And it, you know, it's not.
36:10I think it is clear that comparison
36:13as people sometimes make it out to be.
36:15But you know,
36:16I think what what matters is then when
36:18we bring this information to patients.
36:19And I think this is where you know ACP,
36:21you know,
36:22sort of hit the nail on the
36:23head of like you know,
36:24it really is a shared decision
36:27making process.
36:28And for those of you who are not familiar,
36:29sort of there,
36:30there's a whole field of
36:31shared decision making,
36:32and you know it's defined as
36:34an interactive process between
36:35patient and or their family
36:37members and clinicians.
36:38And the goal is to engage patients
36:41and decision making provide
36:42patients with accurate information
36:44about options and outcomes,
36:46and then tailor the treatment plans
36:48to patients goal and preferences.
36:51So even though I tend to have a bias,
36:53I thought as I you know, I.
36:54I sort of almost tell all my patients,
36:56I want them to do some behavioral therapy.
36:58Just because I think it's effective
37:00and I think it's safer, you know it's.
37:02I know it's not going to work
37:03for all my patients and you know,
37:05every time I see a patient with insomnia,
37:07we the first conversation we have
37:10is the shared decision making
37:11like you know what are,
37:13what are the benefits of
37:15medications or behavioral therapies?
37:17Let's think through the process.
37:20What would work best for you?
37:21What are you interested in and you know
37:22I can guide some of the conversation.
37:24You know 'cause I I bring some
37:25of that to the table, but again,
37:27it's individualized for every patient.
37:30And these are the three components,
37:31so it's shared decision making essentially
37:34combines medical evidence where it's clear,
37:36accurate and unbiased.
37:37Medical evidence about what are
37:39the alternatives to treatment,
37:41including no intervention.
37:42So again,
37:43when treating insomnia,
37:44we can try behavioral strategies.
37:46We can try pharmacological strategies.
37:48We can try new treatment.
37:52And this action and this meets
37:53together with you,
37:54know your your skills and knowledge
37:56and all that training you have
37:58as a clinician in communicating.
37:59You know what the options are to treatment.
38:02What is the evidence?
38:04Taking that information and tailoring
38:06tailoring it to your specific patient,
38:08their beliefs,
38:10attitudes and medical needs,
38:12and engaging with the patients who
38:14and trying to help them think through
38:16what are their personal values and goals,
38:18what are their preferences and
38:20and this is a real skill to to do,
38:22but this is really the crux I think
38:25of how we take this medication,
38:27how how we take this information
38:29actually bring it to to the bedside.
38:31So in summary,
38:31you know these are the the the the
38:34central steppes of shared decision making.
38:36So you have to seek your
38:38patients participation,
38:39help the patients explore their options,
38:41assess their values and preferences,
38:43and sometimes it's clear and
38:44upfront and sometimes it's not.
38:46And then actually you know,
38:47formulate that treatment plan
38:49based on these decisions you have.
38:52Assess how the patient is feeling about
38:54them so you know the you know based,
38:56so your role just to summarize is
38:58providing information on benefits
39:00and risks talking to the patients
39:03about their preferences and then
39:05also not just telling them.
39:07What to do?
39:08But actually how to do it so the
39:11implementation there?
39:12There's some small literature.
39:13Janet Chung actually published a study and
39:16thinking about patient decision making.
39:18You know for insomnia,
39:19I'm not going to go through it here,
39:21but you know,
39:21she sort of lays out a similar
39:23pathway in a recent publication
39:25in Behavioral Sleep Medicine.
39:26For this as well.
39:29And then also just to keep in mind
39:31that you know keep that the patient
39:32in preferences are are not in a
39:34vacuum in the patients much more
39:36than than the person in clinic and
39:38their preferences and their ability
39:40to actually implement their plan
39:41are actually going to be influenced
39:43by not just the knowledge that
39:46you're giving them in clinic,
39:47which is up here and skills, but also.
39:51Their their motivation for treatment
39:54for different treatment options,
39:56their goals for treatment,
39:58their beliefs about the treatments
40:00and consequences of the treatments,
40:02emotions, how they think they're
40:04going to respond to a treatment
40:06as well as opportunity.
40:07So again, you know you could have
40:09a patient who absolutely wants to
40:10do cognitive behavioral therapy,
40:11but if they can't access,
40:13you know someone who provide that
40:16insurance coverage language barriers.
40:18That's just going to, you know,
40:20impeach or implementation of the plan.
40:23Relatedly, it's important to know you
40:25know what's acceptable for the patients too,
40:28and we hear a lot of this in in
40:29in insomnia clinic to, you know,
40:31medications don't work for me.
40:33Behavioral treatments going
40:34to be too difficult.
40:35My my meds are working,
40:37so it's just important to
40:38to emphasize what it what.
40:39Is that patient actually bringing to
40:41the table when you're making these
40:43decisions and party Rule 2 is to
40:45help guide the patients and what is
40:47actually feasible and appropriate for them.
40:49So you know there's some of the obvious
40:51things you know costs language barriers.
40:53Can but things that may not be as obvious
40:55like what are their competing priorities?
40:58Do they actually have time to
40:59like attend 6 to 8 sessions for
41:01cognitive behavioral therapy?
41:03What are their comorbidities?
41:04And you know how is that going
41:05to influence you?
41:06Know, do you choose behavioral therapies?
41:08Do you choose medications?
41:09What medications are you actually going
41:11to choose based on that comorbidity?
41:12'cause it may vary substantially.
41:14Your medication selection based
41:16on those factors,
41:17and then I think it's also important
41:19to keep in mind as a practitioner,
41:21what are your time and costs.
41:23You know, I I do.
41:24Behavioral treatments in my my practice.
41:27I do brief behavioral treatments,
41:28but you know,
41:28I can't do it for all of the
41:30patients 'cause I simply don't have.
41:32You know enough clinic slobs
41:33and enough follow-up slobs and
41:35enough support to be able to do it
41:37all the time for each patient.
41:38So I sort of have to select which
41:40patients I'm actually able to do it
41:42in and then you know refer to CBT.
41:44Those patients that that I don't feel
41:45like I can work with and I think it's
41:48important to have that honest conversation.
41:50So again,
41:50this is just a slide showing
41:52that even in the best laid plans,
41:53you know the actual implementation
41:55of these plans is always gonna
41:58vary and and be more challenging
42:00and unexpected that you think.
42:02One thing we do to sort of,
42:04you know, counteract some of the
42:06the preferences or beliefs and and
42:09and sometimes distorted beliefs
42:11that patients have about any of
42:14these treatments for insomnia.
42:15Is to is to, you know,
42:17change their expectations,
42:18even if it's settled for not and
42:20you know every patient with insomnia
42:22needs to be taught about realistic
42:25expectations and and you know.
42:26And we always discuss no.
42:28Just start with the basic that you know.
42:30Sleep is an involuntary biological process
42:33they can't will themselves to sleep.
42:35The sleep medications don't work by
42:38making sleep a more voluntary process,
42:40you know that they're not that
42:42great for knocking people out that
42:43they're actually good with giving
42:45people a little bit of a push.
42:46So you need to have that.
42:47Homeostatic sleep drive and just
42:49let the medications push them into
42:51sleep and patients also need to have
42:53realistic expectations about how well
42:55the sleep medications are going to work.
42:59But also you know what,
43:00what do we expect from the medications
43:02in terms of their response,
43:04you know,
43:04and and often tell patients you
43:06know they're not.
43:06They're not going to be able to
43:07be on like the Olympic sleep team.
43:09They're not going to be elite sleepers.
43:11Our goal is to getting them.
43:12You know enough sleep so that they're
43:14actually able to function during the
43:16day and feel like they have improved
43:18mood and concentration and memory and
43:20not let their sleep disturbance you
43:21know be be a focus or cause problems
43:24and how they're feeling during the day.
43:27In terms of leaving in so against,
43:29these are even patients were
43:31prescribing medications and we're
43:32weaving in some of these behavioral
43:35principles about expectations,
43:36and it's also equally important when
43:38you're prescribing medications to actually
43:40go through the patient instructions.
43:42'cause taking out a medication
43:45is actually a daily behavior,
43:47and often they they're very
43:49motivated to take the medications.
43:50But what we find in sleep clinic
43:52and what they've actually shown in
43:54studies that people often don't
43:55take the medications the right way.
43:57Either 'cause they have unrealistic
43:59expectations about how the medications
44:02work haven't explained some of
44:03the safety issues we see.
44:05Patients often dose long acting
44:07medications in the middle of the night,
44:09and so you need to be really clear
44:12on what medication they're taking,
44:13what time they're supposed to take,
44:15the medications,
44:16and about you know details of the
44:19medication in terms of you know,
44:21should they take over food or avoid out.
44:24Patient for how long they're gonna
44:26be on the medication on so these
44:28are all really important.
44:29You know,
44:30behavioral principles towards implementing
44:32a pharmacological and insomnia.