Insomnia is the most common type of sleep disorder in the clinic.Long-term insomnia seriously affects people's work and life, and the incidence of insomnia is increasing year by year.In order to provide reference for the clinic, this paper summarizes the current advances in the treatment of insomnia, including pharmacotherapy and non-pharmacotherapy.Non-pharmacotherapy includes cognitive behavioral therapy and physical therapy.Pharmacotherapy includes benzodiazepine receptor agonists, including benzodiazepine and non-benzodiazepine hypnotics, melatonin and melatonin receptor agonists, antidepressant drugs with sedative effects, antipsychotic drugs, antihistamines that have central inhibitory effects, Chinese medicine.
失眠的诊断可依据世界卫生组织(WHO)制定的《疾病和有关健康问题的国际统计分类》(International Classification of Diseases,ICD)第10版[6],或美国精神病学会(American Psychological Association,APA)在2013年制定的美国《精神疾病的诊断和统计手册》(Diagnostic and Statistical Manual of Mental Disorders,DSM)第5版[7],以及在2014年由美国睡眠学会(American Academy of Sleep Medicine,AASM)发布的睡眠障碍国际分类(International Classification of Sleep Disorders,ICSD)第3版[5]。根据最新发布的ICSD-3失眠诊断标准,短期失眠障碍和慢性失眠障碍都需满足以下条件,①有以下一种或多种症状:入睡困难;难以维持睡眠;早醒;不在规定时间入睡;在父母或照料者督促下才能入睡;②疲劳或不适感;注意力或记忆受损表现;社会行为受损;情绪障碍,易怒;白天嗜睡;行为问题(易激惹,冲动,多动);职业困倦或精力减退;容易犯错或发生事故;过度关注睡眠满意度;③不是因缺乏睡眠时间和环境原因所致的失眠。其中短期失眠障碍另须满足:持续少于3个月;不能被其他睡眠障碍疾病解释。慢性失眠障碍另须满足:1周至少出现3次;至少持续3个月;不能被其他睡眠障碍疾病解释[5]。
WALSH JK,COULOUVRATC,HAJAKG,et al.Nighttime insomnia symptoms and perceived health in the America Insomnia Survey (AIS)[J].Sleep,2011,34(8):997-1011.
To explore the distribution of the 4 cardinal nighttime symptoms of insomnia-difficulty initiating sleep (DIS), difficulty maintaining sleep (DMS), early morning awakening (EMA), and nonrestorative sleep (NRS)-in a national sample of health plan members and the associations of these nighttime symptoms with sociodemographics, comorbidity, and perceived health. Cross-sectional telephone survey of 6,791 adult respondents. None. Current insomnia was assessed using the Brief Insomnia Questionnaire (BIQ)-a fully structured validated scale generating diagnoses of insomnia using DSM-IV-TR, ICD-10, and RDC/ICSD-2 inclusion criteria. DMS (61.0%) and EMA (52.2%) were more prevalent than DIS (37.7%) and NRS (25.2%) among respondents with insomnia. Sociodemographic correlates varied significantly across the 4 symptoms. All 4 nighttime symptoms were significantly related to a wide range of comorbid physical and mental conditions. All 4 also significantly predicted decrements in perceived health both in the total sample and among respondents with insomnia after adjusting for comorbid physical and mental conditions. Joint associations of the 4 symptoms predicting perceived health were additive and related to daytime distress/impairment. Individual-level associations were strongest for NRS. At the societal level, though, where both prevalence and strength of individual-level associations were taken into consideration, DMS had the strongest associations. The extent to which nighttime insomnia symptoms are stable over time requires future long-term longitudinal study. Within the context of this limitation, the results suggest that core nighttime symptoms are associated with different patterns of risk and perceived health and that symptom-based subtyping might have value.
SOLDATOS CR,ALLAERT FA,OHTAT,et al.How do individuals sleep around the world? Results from a single-day survey in ten countries[J].Sleep Med,2005,6(1):5-13.
BACKGROUND AND PURPOSE: To describe between-country differences in both the prevalence and type of sleep disorders seen across the globe, and to provide information on how impaired sleep impacts daytime functioning. PATIENTS AND METHODS: The study is a large-scale, global cross-sectional survey conducted on International Sleep Well Day (March 21), 2002. A standardized questionnaire was used in 10 countries under the guidance of local survey managers. In addition, the Athens Insomnia Scale (AIS) and the Epworth Sleepiness Scale (ESS) were completed. Subjects included in the study were adults from 10 countries representing different continents with clear variations in lifestyle. RESULTS: The total number of questionnaires collected was 35,327. Overall, 24% of subjects reported that they did not sleep well. According to self-assessments using the AIS, 31.6% of subjects had 'insomnia', while another 17.5% could be considered as having 'sub-threshold insomnia'. According to ESS scores, 11.6% of subjects were found to be 'very sleepy' or 'dangerously sleepy' during the day. CONCLUSIONS: Although there seem to be important global variations in the prevalence of insomnia, its symptoms and their management, about one in four individuals do not think they sleep well. Moreover, self-reported sleep problems could be underestimated in the general population. Overall, there is a need for increased awareness of the importance of disturbed sleep and the improved detection and management of sleep disorders.
American Academy of Sleep Medicine.International Classi-fication of Sleep Disorders[M].3rd edition. Darien,IL:American Academy of Sleep Medicine,2014.
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American Psychiatric Association.Sleep-WakeDisorders.Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition (DSM-5)[M].Arlington,VA:American Psychiatric Association,2013.
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QASEEMA,KANSAGARAD,FORCIEA MA,et al.Clini-cal guidelines committee of the american college of physicians. Management of chronic insomnia disorder in adults:a clinical practice guideline from the american college of physicians[J].Ann Intern Med,2016,165(2):125-133
Abstract Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the management of chronic insomnia disorder in adults. Methods: This guideline is based on a systematic review of randomized, controlled trials published in English from 2004 through September 2015. Evaluated outcomes included global outcomes assessed by questionnaires, patient-reported sleep outcomes, and harms. The target audience for this guideline includes all clinicians, and the target patient population includes adults with chronic insomnia disorder. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Recommendation 1: ACP recommends that all adult patients receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia disorder. (Grade: strong recommendation, moderate-quality evidence). Recommendation 2: ACP recommends that clinicians use a shared decision-making approach, including a discussion of the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia disorder in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (Grade: weak recommendation, low-quality evidence).
TRAUER JM,QIAN MY,DOYLE JS,et al.Cognitive be-havioral therapy for chronic insomnia:a systematic review and meta-analysis[J].Ann Intern Med,2015,163(3):191-204.
Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.To determine the efficacy of CBT-i on diary measures of overnight sleep in adults with chronic insomnia.Searches of MEDLINE, EMBASE, PsycINFO, CINAHL, the Cochrane Library, and PubMed Clinical Queries from inception to 31 March 2015, supplemented with manual screening.Randomized, controlled trials assessing the efficacy of face-to-face, multimodal CBT-i compared with inactive comparators on overnight sleep in adults with chronic insomnia. Studies of insomnia comorbid with medical, sleep, or psychiatric disorders were excluded.Study characteristics, quality, and data were assessed independently by 2 reviewers. Main outcome measures were sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE%).Among 292 citations and 91 full-text articles reviewed, 20 studies (1162 participants [64% female; mean age, 56 years]) were included. Approaches to CBT-i incorporated at least 3 of the following: cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation. At the posttreatment time point, SOL improved by 19.03 (95% CI, 14.12 to 23.93) minutes, WASO improved by 26.00 (CI, 15.48 to 36.52) minutes, TST improved by 7.61 (CI, -0.51 to 15.74) minutes, and SE% improved by 9.91% (CI, 8.09% to 11.73%). Changes seemed to be sustained at later time points. No adverse outcomes were reported.Narrow inclusion criteria limited applicability to patients with comorbid insomnia and other sleep problems, and accuracy of estimates at later time points was less clear.CBT-i is an effective treatment for adults with chronic insomnia, with clinically meaningful effect sizes.None. (PROSPERO registration number: CRD42012002863).
MORIN CM,BOOTZIN RR,BUYSSE DJ,et al.Psycholo-gical and behavioral treatment of insomnia:update of the recent evidence (1998-2004)[J].Sleep,2006,29(11):1398-1414.
Abstract BACKGROUND: Recognition that psychological and behavioral factors play an important role in insomnia has led to increased interest in therapies targeting these factors. A review paper published in 1999 summarized the evidence regarding the efficacy of psychological and behavioral treatments for persistent insomnia. The present review provides an update of the evidence published since the original paper. As with the original paper, this review was conducted by a task force commissioned by the American Academy of Sleep Medicine in order to update its practice parameters on psychological and behavioral therapies for insomnia. METHODS: A systematic review was conducted on 37 treatment studies (N = 2246 subjects/patients) published between 1998 and 2004 inclusively and identified through Psyclnfo and Medline searches. Each study was systematically reviewed with a standard coding sheet and the following information was extracted: Study design, sample (number of participants, age, gender), diagnosis, type of treatments and controls, primary and secondary outcome measures, and main findings. Criteria for inclusion of a study were as follows: (a) the main sleep diagnosis was insomnia (primary or comorbid), (b) at least 1 treatment condition was psychological or behavioral in content, (c) the study design was a randomized controlled trial, a nonrandomized group design, a clinical case series or a single subject experimental design with a minimum of 10 subjects, and (d) the study included at least 1 of the following as dependent variables: sleep onset latency, number and/or duration of awakenings, total sleep time, sleep efficiency, or sleep quality. RESULTS: Psychological and behavioral therapies produced reliable changes in several sleep parameters of individuals with either primary insomnia or insomnia associated with medical and psychiatric disorders. Nine studies documented the benefits of insomnia treatment in older adults or for facilitating discontinuation of medication among chronic hypnotic users. Sleep improvements achieved with treatment were well sustained over time; however, with the exception of reduced psychological symptoms/ distress, there was limited evidence that improved sleep led to clinically meaningful changes in other indices of morbidity (e.g., daytime fatigue). Five treatments met criteria for empirically-supported psychological treatments for insomnia: Stimulus control therapy, relaxation, paradoxical intention, sleep restriction, and cognitive-behavior therapy. DISCUSSION: These updated findings provide additional evidence in support of the original review's conclusions as to the efficacy and generalizability of psychological and behavioral therapies for persistent insomnia. Nonetheless, further research is needed to develop therapies that would optimize outcomes and reduce morbidity, as would studies of treatment mechanisms, mediators, and moderators of outcomes. Effectiveness studies are also needed to validate those therapies when implemented in clinical settings (primary care), by non-sleep specialists. There is also a need to disseminate more effectively the available evidence in support of psychological and behavioral interventions to health-care practitioners working on the front line.
ZACHARIAER,LYBY MS,RITTERBAND LM,et al.Efficacy of internet-delivered cognitive-behavioral therapy for insomnia-a systematic review and meta-analysis of randomized controlled trials[J].Sleep Med Rev,2016,30:1-10.
Cognitive-behavioral therapy for insomnia (CBT-I) has been shown efficacious, but the challenge remains to make it available and accessible in order to meet population needs. Delivering CBT-I over the internet (eCBT-I) may be one method to overcome this challenge. The objective of this meta-analysis was to evaluate the efficacy of eCBT-I and the moderating influence of various study characteristics. Two researchers independently searched key electronic databases (1991 to June 2015), selected eligible publications, extracted data, and evaluated methodological quality. Eleven randomized controlled trials examining a total of 1460 participants were included. Results showed that eCBT-I improved insomnia severity, sleep efficiency, subjective sleep quality, wake after sleep onset, sleep onset latency, total sleep time, and number of nocturnal awakenings at post-treatment, with effect sizes (Hedges's g ) ranging from 0.21 to 1.09. The effects were comparable to those found for face-to-face CBT-I, and were generally maintained at 4鈥48 wk follow-up. Moderator analyses showed that longer treatment duration and higher degree of personal clinical support were associated with larger effect sizes, and that larger study dropout in the intervention group was associated with smaller effect sizes. In conclusion, internet-delivered CBT-I appears efficacious and can be considered a viable option in the treatment of insomnia.
DE BRUIN EJ,BÖGELS SM,OORT FJ,et al.Efficacy of cognitive behavioral therapy for insomnia in adolescents:a randomized controlled trial with internet therapy,group therapy and a waiting list Condition[J].Sleep,2015,38(12):1913-1926.
To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant improvement after treatment and at follow-up compared to WL. This study is the first RCT that provides evidence that CBTI is effective for the treatment of adolescents with insomnia, with medium to large effect sizes. There were small differences between internet- and group therapy, but both treatments reached comparable endpoints. This study was part of the clinical trial: Effectiveness of Cognitive Behavioral Therapy for sleeplessness in adolescents URL: DOI:10.1186/ISRCTN33922163 Registration: ISRCTN33922163.
SPIELMAN AJ,SASKINP,THORPY MJ.Treatment of chronic insomnia by restriction of time in bed[J].Sleep,1987,10(1) :45-56.
A treatment of chronic insomnia is described that is based on the recognition that excessive time spent in bed is one of the important factors that perpetuates insomnia. Thirty-five patients, with a mean age of 46 years and a mean history of insomnia of 15.4 years, were treated initially by marked restriction of time available for sleep, followed by an extension of time in bed contingent upon improved sleep efficiency. At the end of the 8-week treatment program, patients reported an increase in total sleep time (p less than 0.05) as well as improvement in sleep latency, total wake time, sleep efficiency, and subjective assessment of their insomnia (all p less than 0.0001). Improvement remained significant for all sleep parameters at a mean of 36 weeks after treatment in 23 subjects participating in a follow-up assessment. Although compliance with the restricted schedule is difficult for some patients, sleep restriction therapy is an effective treatment for common forms of chronic insomnia.
KRYSTAL AD,ERMANM,ZAMMIT GK,et al.Long-term efficacy and safety of zolpidem extended-release 12.5 mg,administered 3 to 7 nights per week for 24 weeks,in patients with chronic primary insomnia:a 6-month,randomized,double-blind,placebo-controlled, parallel-group,multicenter study[J].Sleep,2008,31(1) :79-90.
National Institutes ofHational.Institutes of health state of the science conference statement on manifestations and management of chronic insomnia in adults,June 13-15,2005[J].Sleep,2005,28(9) :1049-1057.
GANZONIE,SANTONI JP,CHEVILLARDV,et al.Zolpi-dem in insomnia:a 3-year post-marketing surveillance study in Switzerland[J].J Int Med Res,1995,23(1) :61-73
A multicentre post-marketing surveillance study was conducted in Switzerland in routine practice and involved 1972 insomniac patients treated with zolpidem, an imidazopyridine hypnotic agent. The patients were representative of the general insomniac population (65% women; mean age 55 years; 29% over 65). Of the patients, 87% were treated with a zolpidem dosage of 10 mg/day and the median treatment duration was 30 days. All adverse events were collected through spontaneous reporting. A total of 175 patients (8.9%) reported 343 adverse events, and 102 (5.2%) of them discontinued treatment. CNS (central nervous system)-related adverse events accounted for 66% of the total, the most common events being residual daytime sedation and insufficient efficacy in 3.7% and 1.6%, respectively; confusion, disorientation, nervousness, nightmares, amnesia, impaired concentration and anxiety were observed in a lower proportion. Gastro-intestinal symptoms, headache and skin reactions were the most frequent non-CNS related effects. No serious adverse event was reported and no new risk factors or at-risk populations were identified. The safety profile of zolpidem is thus consistent with its known pharmacological properties, the results of previous clinical trials, and the cumulative international experience gained with this short-acting hypnotic drug.
HAJAKG,BANDELOWB,ZULLEYJ,et al.“As needed”pharmacotherapy combined with stimulus control treatment in chronic insomnia——assessment of a novel intervention strategy in a primary care setting[J].Ann Clin Psychiatry,2002,14(1):1-7.
Discontinuous, nonnightly hypnotic therapy in the treatment of chronic insomnia is likely to offer benefits such as maintained efficacy while preventing unnecessary long-term nightly use associated with the risk of tolerance and dependence. Based on the favorable results seen in four zolpidem studies using increasing degrees of flexibility in drug intake schedule, we developed the concept further and investigated “as needed” zolpidem pharmacotherapy amended by the optional use of stimulus control in conditions close to the “real life” practice. In a prospective, observational open study in 550 primary care settings throughout Germany, 2690 patients with chronic insomnia (mean age 59 years, 66% female, 50% with pharmacotherapy pretreatment) were treated with zolpidem according to an “as-needed” (pro re nata) administration treatment schedule (up to five tablets per week, intake nights chosen by the patient), amended by the optional use of behavioral therapy (stimulus control) during drug-free nights. After the three weeks' treatment period, in two thirds of patients (63%) the weekly number of tablets used was reduced in contrast to baseline. The average zolpidem tablet number taken decreased by 28% (from 3.7 to 2.6 per week; p < 0.00001) without any significant impact on the treatment efficacy assessed through the CGI. The subjective latency to sleep onset was reduced from a mean of 74 27 min ( p < 0.00001) and total sleep time increased from 5.0 to 6.8 h ( p < 0.00001). Efficacy of treatment was rated as very good or good in 93% by the investigators. Adverse events were observed only in 1.2% of patients and were generally of mild nature. No serious adverse event occurred. These results underline the validity of the zolpidem “as needed” treatment concept. It is feasible in a safe and effective manner also in a primary care setting and can be amended by stimulus control. Further research is warranted on the contributions of both treatment components to effectiveness and on the efficacy and safety issues of long-term use.
EBBENS MM,VERSTERJC.Clinical evaluation of zaleplon in the treatment[J].Nat Sci Sleep,2010,6(17) :115-126.
Zaleplon is a pyrazolopyrimidine hypnotic used for the treatment of insomnia. Zaleplon binds preferentially at the 伪1尾2纬2 subunit of gamma aminobutyric acid type A (GABAA) receptors in the central nervous system, and has a half-life of about one hour. Efficacy studies show that zaleplon is a suitable hypnotic for sleep initiation purposes. However, because of its short half-life, zaleplon is less effective in sleep maintenance when compared with other hypnotics. Nevertheless, zaleplon does increase total sleep time. No rebound effects are observed after treatment discontinuation. The use of zaleplon is relatively safe. Adverse effects are mild and of short duration. No important interactions have been reported, and there is no evidence of abuse potential. Relative to benzodiazepine hypnotics, the biggest advantage of zaleplon is that current evidence suggests it does not produce residual next-day effects. As early as four hours after intake of zaleplon, no effects on cognitive, memory, psychomotor performance, and the ability to drive a car have been reported. Future studies should confirm these findings, and comparisons with new nonbenzodiazepine hypnotics should determine the importance of zaleplon in the future treatment of insomnia.
GOONERATNE NS,GEHRMANP,GURUBHAGAVATU-LAI,et al.Effectiveness of ramelteon for insomnia symptoms in older adults with obstructive sleep apnea: a randomized placebo-controlled pilot study[J].J Clin Sleep Med,2010,6(6):572-580.
To evaluate the effectiveness of ramelteon, a melatonin receptor agonist, for the treatment of insomnia in older adults starting auto-titrating positive airway pressure (APAP) therapy for sleep apnea.A parallel group, randomized, double-blind, placebo-controlled pilot effectiveness clinical trial. The study enrolled 21 research study participants who were ≥ 60 years old and had obstructive sleep apnea, defined by an apnea-hypopnea index (AHI) ≥ 5 events/h, with complaints of insomnia. The primary outcome measure was change in sleep onset latency determined from polysomnography at 4 weeks. Research study participants, all of whom were starting on APAP, were randomized to ramelteon 8 mg (n = 8) or placebo (n = 13).Ramelteon treatment was associated with a statistically significant difference in sleep onset latency (SOL) as measured by polysomnography of 28.5 min (± 16.2 min) compared to placebo (95% C.I. 8.5 min to 48.6 min, effect size 1.35, p = 0.008). This was due to a 10.7 (± 17.0) min SOL reduction in the ramelteon arm and a 17.8 (± 23.5) min SOL increase in the placebo arm. No change was noted in subjective sleep onset latency (-1.3 min, ± 19.3 min, 95% C.I.: -21.4 min to 18.7 min). No statistically significant changes were noted in the AHI, sleep efficiency (polysomnography and self-report), APAP adherence, Pittsburgh Sleep Quality Index global score, or Epworth Sleepiness Scale score when comparing ramelteon vs. placebo. Four adverse events occurred in the ramelteon arm and 2 in the placebo arm; none were considered to be related to treatment.Ramelteon was effective in improving objective, but not subjective, sleep onset latency even in older adults who were starting APAP therapy for sleep apnea. Further research is warranted in examining the role of ramelteon in the care of older adults with insomnia symptoms and sleep apnea.
ERMANM, SEIDEND, ZAMMITG, et al.An efficacy, safety, and dose-response study of ramelteon in patients with chronic primary insomnia[J].Sleep Med,2006,7(1):17-24.
To evaluate the efficacy, safety, and dose response of Ramelteon, a novel highly selective MT 1/MT 2 receptor agonist, in patients with chronic primary insomnia. A randomized, multicenter, double-blind, placebo-controlled, five-period crossover study design was performed. A total of 107 patients, aged 18鈥64 years, were randomized into a dosing sequence that included 4, 8, 16, and 32 mg of ramelteon and placebo. Patients received all five treatments, with a 5- to 12-day washout period between treatments, and served as their own controls. Medication was administered 30 min before habitual bedtime and polysomnographic monitoring. Next-day residual effects were assessed with two visual analog scales (mood and feeling), digit symbol substitution test (DSST), word-list memory tests (immediate recall and delayed recall), and a post-sleep questionnaire that ascertained patients' alertness and ability to concentrate. All tested doses of ramelteon resulted in statistically significant reductions in latency to persistent sleep (LPS) and increases in total sleep time (TST). No next-day residual effects were apparent at any dose, as compared with placebo. There were no differences in the number or type of adverse events between any active treatment and placebo group. The most commonly reported adverse events were headache, somnolence, and sore throat. Ramelteon demonstrated a statistically significant reduction in LPS and a statistically significant increase in TST, with no apparent next-day residual effects, in patients with chronic primary insomnia.
ROTH AJ,MCCALL WV,LIGUORIA.Cognitive,psycho-motor and polysomnographic effects of trazodone in primary insomniacs[J].J Sleep Res,2011,20(4):552-558.
Summary Top of page Summary Introduction Methods Results Discussion Declarations of Interest Acknowledgements References Trazodone is prescribed widely as a sleep aid, although it is indicated for depression, not insomnia. Its daytime cognitive and psychomotor effects have not been investigated systematically in insomniacs. The primary goal of this study was to quantify, in primary insomniacs, the hypnotic efficacy of trazodone and subsequent daytime impairments. Sixteen primary insomniacs (mean age 44years) participated, with insomnia confirmed by overnight polysomnography (sleep efficiency鈮85%). Trazodone 50mg was administered to participants 30min before bedtime for 7days in a 3-week, within-subjects, randomized, double-blind, placebo-controlled design. Subjective effects, equilibrium (anterior/posterior body sway), short-term memory, verbal learning, simulated driving and muscle endurance were assessed the morning after days 1 and 7 of drug administration. Sleep was evaluated with overnight polysomnography and modified Multiple Sleep Latency Tests (MSLT) on days 1 and 7. Trazodone produced small but significant impairments of short-term memory, verbal learning, equilibrium and arm muscle endurance across time-points. Relative to placebo across test days, trazodone was associated with fewer night-time awakenings, minutes of Stage 1 sleep and self-reports of difficulty sleeping. On day 7 only, slow wave sleep was greater and objective measures of daytime sleepiness lower with trazodone than with placebo. Although trazodone is efficacious for sleep maintenance difficulties, its associated cognitive and motor impairments may provide a modest caveat to health-care providers.
XIE CL,GUY,WANG WW,et al.Efficacy and safety of Suanzaoren decoction for primary insomnia:a systematic review of randomized controlled trials[J].BMC Complement Altern Med,2013,13:18.
Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people???s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed.
WILT TJ,MACDONALDR,BRASUREM,et al.Pharma-cologic treatment of insomnia disorder:an evidence report for a clinical practice guideline by the American College of Physicians[J].Ann Intern Med,2016,165(2):103-112.
Abstract Background: Pharmacologic interventions are often prescribed for insomnia disorder. Purpose: To assess the benefits, harms, and comparative effectiveness of pharmacologic treatments for adults with insomnia disorder. Data Sources: Several electronic databases (2004-September 2015), reference lists, and U.S. Food and Drug Administration (FDA) documents. Study Selection: 35 randomized, controlled trials of at least 4 weeks' duration that evaluated pharmacotherapies available in the United States and that reported global or sleep outcomes; 11 long-term observational studies that reported harm information; FDA review data for nonbenzodiazepine hypnotics and orexin receptor antagonists; and product labels for all agents. Data Extraction: Data extraction by single investigator confirmed by a second reviewer; dual-investigator assessment of risk of bias; consensus determination of strength of evidence. Data Synthesis: Eszopiclone, zolpidem, and suvorexant improved short-term global and sleep outcomes compared with placebo, although absolute effect sizes were small (low- to moderate-strength evidence). Evidence for benzodiazepine hypnotics, melatonin agonists, and antidepressants, and for most pharmacologic interventions in older adults, was insufficient or low strength. Evidence was also insufficient to compare efficacy within or across pharmacotherapy classes or versus behavioral therapy. Harms evidence reported in trials was judged insufficient or low strength; observational studies suggested that use of hypnotics for insomnia was associated with increased risk for dementia, fractures, and major injury. The FDA documents reported that most pharmacotherapies had risks for cognitive and behavioral changes, including driving impairment, and other adverse effects, and they advised dose reduction in women and in older adults. Limitations: Most trials were small and short term and enrolled individuals meeting stringent criteria. Minimum important differences in outcomes were often not established or reported. Data were scant for many treatments. Conclusion: Eszopiclone, zolpidem, and suvorexant may improve short-term global and sleep outcomes for adults with insomnia disorder, but the comparative effectiveness and long-term efficacy of pharmacotherapies for insomnia are not known. Pharmacotherapies for insomnia may cause cognitive and behavioral changes and may be associated with infrequent but serious harms. Primary Funding Source: Agency for Healthcare Research and Quality.
ASNIS GM,THOMASM,HENDERSON MA.Pharmaco-therapy treatment options for insomnia:a primer for clinicians[J].Int J Mol Sci,2015,17(1):E50.
Insomnia is a prevalent disorder with deleterious effects such as decreased quality of life, and a predisposition to a number of psychiatric disorders. Fortunately, numerous approved hypnotic treatments are available. This report reviews the state of the art of pharmacotherapy with a reference to cognitive behavioral therapy for insomnia (CBT-I) as well. It provides the clinician with a guide to all the Food and Drug Administration (FDA) approved hypnotics (benzodiazepines, nonbenzodiazepines, ramelteon, low dose sinequan, and suvorexant) including potential side effects. Frequently, chronic insomnia lasts longer than 2 years. Cognizant of this and as a result of longer-term studies, the FDA has approved all hypnotics since 2005 without restricting the duration of use. Our manuscript also reviews off-label hypnotics (sedating antidepressants, atypical antipsychotics, anticonvulsants and antihistamines) which in reality, are more often prescribed than approved hypnotics. The choice of which hypnotic to choose is discussed partially being based on which segment of sleep is disturbed and whether co-morbid illnesses exist. Lastly, we discuss recent label changes required by the FDA inserting a warning about 鈥渟leep-related complex behaviors鈥, e.g., sleep-driving for all hypnotics. In addition, we discuss FDA mandated dose reductions for most zolpidem preparations in women due to high zolpidem levels in the morning hours potentially causing daytime carry-over effects.
... 失眠的诊断可依据世界卫生组织(WHO)制定的《疾病和有关健康问题的国际统计分类》(International Classification of Diseases,ICD)第10版[6],或美国精神病学会(American Psychological Association,APA)在2013年制定的美国《精神疾病的诊断和统计手册》(Diagnostic and Statistical Manual of Mental Disorders,DSM)第5版[7],以及在2014年由美国睡眠学会(American Academy of Sleep Medicine,AASM)发布的睡眠障碍国际分类(International Classification of Sleep Disorders,ICSD)第3版[5].根据最新发布的ICSD-3失眠诊断标准,短期失眠障碍和慢性失眠障碍都需满足以下条件,①有以下一种或多种症状:入睡困难;难以维持睡眠;早醒;不在规定时间入睡;在父母或照料者督促下才能入睡;②疲劳或不适感;注意力或记忆受损表现;社会行为受损;情绪障碍,易怒;白天嗜睡;行为问题(易激惹,冲动,多动);职业困倦或精力减退;容易犯错或发生事故;过度关注睡眠满意度;③不是因缺乏睡眠时间和环境原因所致的失眠.其中短期失眠障碍另须满足:持续少于3个月;不能被其他睡眠障碍疾病解释.慢性失眠障碍另须满足:1周至少出现3次;至少持续3个月;不能被其他睡眠障碍疾病解释[5]. ...
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... 失眠的诊断可依据世界卫生组织(WHO)制定的《疾病和有关健康问题的国际统计分类》(International Classification of Diseases,ICD)第10版[6],或美国精神病学会(American Psychological Association,APA)在2013年制定的美国《精神疾病的诊断和统计手册》(Diagnostic and Statistical Manual of Mental Disorders,DSM)第5版[7],以及在2014年由美国睡眠学会(American Academy of Sleep Medicine,AASM)发布的睡眠障碍国际分类(International Classification of Sleep Disorders,ICSD)第3版[5].根据最新发布的ICSD-3失眠诊断标准,短期失眠障碍和慢性失眠障碍都需满足以下条件,①有以下一种或多种症状:入睡困难;难以维持睡眠;早醒;不在规定时间入睡;在父母或照料者督促下才能入睡;②疲劳或不适感;注意力或记忆受损表现;社会行为受损;情绪障碍,易怒;白天嗜睡;行为问题(易激惹,冲动,多动);职业困倦或精力减退;容易犯错或发生事故;过度关注睡眠满意度;③不是因缺乏睡眠时间和环境原因所致的失眠.其中短期失眠障碍另须满足:持续少于3个月;不能被其他睡眠障碍疾病解释.慢性失眠障碍另须满足:1周至少出现3次;至少持续3个月;不能被其他睡眠障碍疾病解释[5]. ...
Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition (DSM-5)
1
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... 失眠的诊断可依据世界卫生组织(WHO)制定的《疾病和有关健康问题的国际统计分类》(International Classification of Diseases,ICD)第10版[6],或美国精神病学会(American Psychological Association,APA)在2013年制定的美国《精神疾病的诊断和统计手册》(Diagnostic and Statistical Manual of Mental Disorders,DSM)第5版[7],以及在2014年由美国睡眠学会(American Academy of Sleep Medicine,AASM)发布的睡眠障碍国际分类(International Classification of Sleep Disorders,ICSD)第3版[5].根据最新发布的ICSD-3失眠诊断标准,短期失眠障碍和慢性失眠障碍都需满足以下条件,①有以下一种或多种症状:入睡困难;难以维持睡眠;早醒;不在规定时间入睡;在父母或照料者督促下才能入睡;②疲劳或不适感;注意力或记忆受损表现;社会行为受损;情绪障碍,易怒;白天嗜睡;行为问题(易激惹,冲动,多动);职业困倦或精力减退;容易犯错或发生事故;过度关注睡眠满意度;③不是因缺乏睡眠时间和环境原因所致的失眠.其中短期失眠障碍另须满足:持续少于3个月;不能被其他睡眠障碍疾病解释.慢性失眠障碍另须满足:1周至少出现3次;至少持续3个月;不能被其他睡眠障碍疾病解释[5]. ...
Clini-cal guidelines committee of the american college of physicians. Management of chronic insomnia disorder in adults:a clinical practice guideline from the american college of physicians
Efficacy of cognitive behavioral therapy for insomnia in adolescents:a randomized controlled trial with internet therapy,group therapy and a waiting list Condition
Long-term efficacy and safety of zolpidem extended-release 12.5 mg,administered 3 to 7 nights per week for 24 weeks,in patients with chronic primary insomnia:a 6-month,randomized,double-blind,placebo-controlled, parallel-group,multicenter study
“As needed”pharmacotherapy combined with stimulus control treatment in chronic insomnia——assessment of a novel intervention strategy in a primary care setting
, 郑国庆, 林燕
