2023+欧洲失眠指南：失眠的诊断和治疗（英文更新版）.pdf

R E V I E W A R T I C L EThe European Insomnia Guideline:An update on the diagnosisand treatment of insomnia 2023Dieter Riemann1,2|Colin A.Espie3|Ellemarije Altena4|Erna Sif Arnardottir5,6|Chiara Baglioni7|Claudio L.A.Bassetti8|Celyne Bastien9|Natalija Berzina10|Bjrn Bjorvatn11|Dimitris Dikeos12|Leja Dolenc Groselj13|Jason G.Ellis14|Diego Garcia-Borreguero15|Pierre A.Geoffroy16|Michaela Gjerstad17|Marta Gonalves18|Elisabeth Hertenstein19|Kerstin Hoedlmoser20|Tuuliki Hion21|Brigitte Holzinger22|Karolina Janku23|Markus Jansson-Frjmark24,25|Heli Jrnefelt26|Susanna Jernelv24,25|Poul Jrgen Jennum27Samson Khachatryan28|Lukas Krone3,8,19|Simon D.Kyle3|Jaap Lancee29|Damien Leger30|Adrian Lupusor31|Daniel Ruivo Marques32,33|Christoph Nissen34|Laura Palagini35|Tiina Paunio36|Lampros Perogamvros34|Dirk Pevernagie37|Manuel Schabus20|Tamar Shochat38|Andras Szentkiralyi39|Eus Van Someren40,41|Annemieke van Straten42|Adam Wichniak43|Johan Verbraecken44|Kai Spiegelhalder1CorrespondenceDieter Riemann,Department of ClinicalPsychology and Psychophysiology,Centre forMental Disorders,Medical Centre Universityof Freiburg,Faculty of Medicine,University ofFreiburg,Germany;Hauptstr.5,D-79104Freiburg,Germany.Email:dieter.riemannuniklinik-freiburg.deSummaryProgress in the field of insomnia since 2017 necessitated this update of theEuropean Insomnia Guideline.Recommendations for the diagnostic procedure forinsomnia and its comorbidities are:clinical interview(encompassing sleep and medi-cal history);the use of sleep questionnaires and diaries(and physical examination andadditional measures where indicated)(A).Actigraphy is not recommended for theroutine evaluation of insomnia(C),but may be useful for differential-diagnostic pur-poses(A).Polysomnography should be used to evaluate other sleep disorders if sus-pected(i.e.periodic limb movement disorder,sleep-related breathing disorders,etc.),treatment-resistant insomnia(A)and for other indications(B).Cognitive-behaviouraltherapy for insomnia is recommended as the first-line treatment for chronic insomniain adults of any age(including patients with comorbidities),either applied in-personor digitally(A).When cognitive-behavioural therapy for insomnia is not sufficientlyFor affiliations refer to page 26Received:16 August 2023Accepted:21 August 2023DOI:10.1111/jsr.14035This is an open access article under the terms of the Creative Commons Attribution License,which permits use,distribution and reproduction in any medium,provided the original work is properly cited.2023 The Authors.Journal of Sleep Research published by John Wiley&Sons Ltd on behalf of European Sleep Research Society.J Sleep Res.2023;32: of 36https:/doi.org/10.1111/jsr.14035effective,a pharmacological intervention can be offered(A).Benzodiazepines(A),benzodiazepine receptor agonists(A),daridorexant(A)and low-dose sedating antide-pressants(B)can be used for the short-term treatment of insomnia(4 weeks).Longer-term treatment with these substances may be initiated in some cases,consid-ering advantages and disadvantages(B).Orexin receptor antagonists can be used forperiods of up to 3 months or longer in some cases(A).Prolonged-release melatonincan be used for up to 3 months in patients 55 years(B).Antihistaminergic drugs,antipsychotics,fast-release melatonin,ramelteon and phytotherapeutics are notrecommended for insomnia treatment(A).Light therapy and exercise interventionsmay be useful as adjunct therapies to cognitive-behavioural therapy for insomnia(B).KE YWOR DSdiagnosis,evidence-based medicine,guideline,insomnia,treatment1|SUMMARY FOR PATIENTS1.1|What is insomnia?Insomnia is a sleep disorder where people struggle to get off to sleepor to stay asleep.Some individuals have both issues,and others mayalso have early-morning awakenings,where they are unable to getback to sleep after awakening earlier than desired.Importantly,thesenight-time sleep difficulties are coupled with significant daytime prob-lems that affect the persons ability to function at their best.Daytimefatigue,low mood or irritability,and problems with attention or con-centration are usually experienced.To be diagnosed with an“insom-nia disorder”,these difficulties have to occur at least several times aweek over a period of 3 months.Insomnia is a very common disorder(up to 10%of the adult population in Europe)and,in addition to agreat deal of personal suffering,it also results in increased costs tohealthcare services and to society at large(e.g.reduced productivityat work)1.2|How can insomnia be treated?Currently,there are two ways to treat insomnia.According to scien-tific evidence the first,and the most effective,approach is cognitive-behavioural therapy for insomnia(CBT-I).As the name suggests,CBT-I addresses the mental or cognitive aspects of insomnia(e.g.theracing mind),and the behavioural aspect reestablishes a healthy sleeppattern.CBT-I can be offered as single or group therapy(face-to-faceF2F)or as a digital therapy,where it is delivered as a web-basedintervention or on a treatment-based app.The second approach totreat insomnia is pharmacological(i.e.pill-based).There is a variety ofsleep medications available,but it is recommended that these are onlytaken for a short period(no longer than 4 weeks)to avoid the bodygetting used to them or becoming dependent upon them.In somecases,after weighing the advantages and disadvantages,some medi-cations may be given for longer periods of time.1.3|Who developed this guideline?This European Insomnia Guideline 2023 was developed by a group ofresearchers and clinicians in the European Sleep Research Society(ESRS),and the European Insomnia Network(EIN).1.4|Which treatment is recommended by thisguideline?It is recommended that all patients with insomnia,whether they haveother medical conditions or mental health problems,or not,are offeredCBT-I as their initial treatment.CBT-I may be delivered by a clinician ortherapist(F2F),or(preferably guided)digitally using a scientifically dem-onstrated web or mobile treatment platform.If this approach is not suf-ficiently effective,it is recommended that patients and their treatingphysicians should come to a shared decision about whether or not med-ication might be initiated.At present,the evidence suggests that drugtreatments in general should be limited to,at most,4 weeks in duration,and even then with care:tolerance develops within days to weeks.Doseincreases are not advised,and may accelerate the development ofdependence.In some cases,longer treatment periods may be indicated,carefully weighing the advantages and disadvantages.2|GUIDELINE REPORTThis guideline is an update of the European Insomnia Guideline thatwas published in 2017(Riemann,Baum,et al.,2017),and developedby a task force of the ESRS and the EIN.The European InsomniaGuideline was based on the German Insomnia Guideline(Riemann,Baglioni,et al.,2017)and was endorsed by the World Sleep Society(Morin et al.,2021).A revision of the German Insomnia Guideline isunderway(Spiegelhalder et al.,2023).This first update of theEuropean Insomnia Guideline is inspired by and draws upon this revi-sion of the German Insomnia Guideline.2 of 36RIEMANNET AL.This guideline focuses on the target population of adult patientssuffering from chronic insomnia as defined by the International Classi-fication of Diseases(ICD-10/ICD-11).This includes all subtypes ofinsomnia,for example,non-organic insomnia/chronic insomnia andinsomnia comorbid with somatic(formerly named“organic”insomnia)or mental disorders.The guideline addresses adult patients over theage of 18 years.The literature on insomnia in children and adoles-cents was not reviewed.The guideline is based on a review of all relevant international lit-erature and has a particular salience to the provision of clinical ser-vices across Europe.It will be of interest to health professionals whoare involved in the diagnosis and treatment of insomnia on either anout-or in-patient basis.Most insomnia is managed by general practi-tioners in primary care settings,and by clinicians who are not special-ists in sleep medicine.The guideline should also be helpful to suchindividuals(i.e.who treat insomnia in routine clinical care withoutaccess to advanced expertise or facilities).The guideline should alsobe useful to specialists in psychiatry,clinical psychology/psychother-apy,psychosomatic medicine,neurology,occupational medicine,phar-macy/pharmacology and other medical specialties who commonly seepatients with insomnia in the context of other comorbid physical andmental health conditions.Finally,the guideline will be especially rele-vant to professionals trained in sleep medicine and who are membersof,or are credentialled by,the ESRS.The revised guideline highlights aspects of clinical managementthat reflect advances in knowledge and practice that can be delin-eated from the updated evidence.Accordingly,less emphasis is placedupon detailed reproduction of extant information that is already out-lined in the 2017 version(Riemann,Baglioni,et al.,2017).2.1|Literature searchThe 2023 update was designed to build upon scientific knowledgeand clinical recommendations from the first guideline,which coveredevidence up to June 2016(Riemann,Baglioni,et al.,2017;Riemann,Baum,et al.,2017).This strategy therefore aimed to both complementand extend previous literature searches,while applying a consistentmethodology.Therefore,to identify relevant studies on the topic of insomnia,asystematic literature search(English language articles only)was con-ducted using the databases Pubmed and Cochrane Library()for the period from June 2016 until October2022(with a further update till May 2023 added).For this update,pri-marily meta-analyses were identified as the basis for grading recom-mendations.If there were several meta-analyses on a given topic,themost recent and qualitatively better meta-analyses were chosen to bepresented in the first instance.The quality of meta-analyses wasjudged by methodological rigour,like low risk of bias,number ofincluded studies or sample sizes.For topics without publishedmeta-analyses,systematic reviews or qualitatively adequate random-ised controlled studies were used.The following keywords were used for literature search:For the area of non-pharmacological treatments,thekeyword“insomnia”was searched in connection withother keywords:“sleep hygiene”,“relaxation”,“mind-fulness”,“behavior therapy”,“cognitive therapy”,“cog-nitive behavioral therapy”,“stimulus control”,“sleeprestriction”,“psychotherapy”,“light therapy”,“exer-cise”,“music”,“non-invasive brain stimulation”.For the area of pharmacological treatments,the key-word“insomnia”was searched in connection withother keywords:“benzodiazepine”,“benzodiazepinereceptor agonist”,“sedating antidepressant”,“antipsy-chotic”,“neuroleptic”,orexin”,“antihistaminic”,“herbal”,“phytotherapy”,“melatonin”.Furthermore,the journal Sleep Medicine Reviews was handsearched for meta-analyses on the diagnosis and treatment of insom-nia.All issues of this journal until October 2022 were incorporated,furthermore articles were incorporated that werein press”.2.2|Writing and consensusThe first draft of this update was formulated and written by DieterRiemann and Kai Spiegelhalder,following partly,and where adequate,theupdateoftheGermaninsomniaguideline(Spiegelhalderet al.,2023).In the next step,all involved authors received the firstdraft of the guideline(15 April 2023)and were asked to provide feed-back within a period of 4 weeks(15 May 2023).After receivingfeedback and incorporating suggested changes/improvements in thesecond draft of the guideline,two online meetings were held on21 July and 1 August 2023 to discuss this version of the guideline andto reach consensus.A third draft of the guideline was then sent outasking for final consent from all authors by 7 August 2023.Finally,theguideline was approved by the guideline committee of the ESRS andbytheESRSboard,beforesubmissiontoJournalofSleepResearch(JSR).2.3|Grading of the evidence/recommendationsIn order to grade the evidence of included studies/meta-analyses toupdate the recommendations in the guideline,a procedure similarto that already outlined in 2017(Lorenz et al.,2001;Riemann,Baglioni,et al.,2017;Riemann,Baum,et al.,2017)was followed(Table 1).The transformation of grades of evidence into grades of recom-mendations was performed according to this scheme and throughconsensus decision between all involved authors.For more details,see supplemental material in Riemann,Baum,et al.(2017).Instead ofonly using two types of recommendations(strong versus weak;Rie-mann,Baum,et al.,2017),we used four steps of recommendations forthis update,ranging from A(very strong recommendation),B(strong),RIEMANNET AL.3 of 36C(weak)to D(very weak recommendation).Please note;levels of evi-dence do not always directly translate into grades of recommendation,as suggested in Table 1;in some cases,a consensus decision becamethe decisive factor for the grading of the recommendation.Reported effect sizes from the meta-analyses were graded as fol-lows:effect sizes(Cohens D)0.2 0.5:small effect;effect sizes 0.5 85%or 90%),the goal isto extend time in bed,often on a weekly basis,to arrive at a sleepopportunity that delivers nightly sleep need,improved sleep continu-ity,and optimised daytime functioning.There is,however,variation inthe configuration of SRT in relation to defining the initial time in bedprescription,minimum time in bed(e.g.4.5,5 or 6 hr),position of thesleep window,and weekly titration parameters(Kyle et al.,2015).SRTis hypothesised to work through restricting,regularising and recondi-tioning sleep opportunity,which drives a cascade in cognitive,beha-vioural and physiological pathways to improve sleep and daytimefunctioning(Maurer et al.,2018;Spielman et al.1987).Evidence fromrandomisedcontrolled trials(RCTs)shows that acute implementationof SRT increases sleepiness proximal to bedtime,decreases pre-sleep8 of 36RIEMANNET AL.TABLE 6Meta-analyses on the efficacy of CBT-I in chronic insomnia/insomnia disorder without comorbiditiesAuthor(year)PopulationNostudies/patientsInterventionStudy endpointsEffects on studyendpointsMorin et al.(1994)Insomnia59/2102CBT-I and singlecomponentsSOL,WASO,NOA,TST(a)Good effects of CBT-Ion all parameters(b)Good follow-up resultsMurtagh andGreenwood(1995)Insomnia66/2007CBT-I and singlecomponentsSOL,NOA,TST,SQ(a)Good effects of CBT-Ion all parameters(b)Good follow-up resultsPallesen et al.(1998)Insomnia,age 50 years13/388CBT-I and singlecomponentsSOL,NOA,WASO,TST(a)Good effects of CBT-Ion all parameters(b)Good follow-up resultsMontgomery andDennis(2004)Primary insomnia,age 60 years7/322CBT-I,bright lightand physicalexerciseSOL,TST,SE,WASO(a)Good effects of CBT-Ion sleep maintenance(b)Almost no effects ofbright light and physicalexerciseIrwin et al.(2006)Insomnia,age 55 yearsversus youngerpatients23/NACBT-I and singlecomponentsSQ,SOL,TST,SE,WASOMedium to strong effectsin older patientsOkajima et al.(2011)Pri