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Insomnia and depression prior to myocardial infarction.

Insomnia is common among patients who subsequently experience an acute myocardial infarction (MI), and is a major symptom of psychiatric depression. The purpose of this study was to determine what proportion of patients reporting insomnia prior to MI have depression. Of 70 patients with a recent MI, 27 (39%) reported having had insomnia for two weeks or longer prior to their MI, 13 of whom (48%) met diagnostic criteria for a major depressive episode (MDE). MDE accounted for a significant proportion of the patients reporting insomnia prior to MI (p less than 0.0001). Furthermore, those patients with insomnia who did not meet diagnostic criteria for MDE nevertheless had three times as many depressive symptoms, excluding sleep disturbance, as did those patients who did not experience insomnia prior to their MI (p less than 0.0009). The implications of this finding are discussed, as well as possible explanations for the relationship between insomnia, depression, and subsequent MI.

Aged↗

Cognitive behavioural therapy for primary insomnia: a systematic review.

AIM: This paper reports a systematic review of seven studies evaluating the efficacy of cognitive behavioural therapy (CBT) for persistent primary insomnia. BACKGROUND: Insomnia is one of the most common health complaints reported in the primary care setting. Although non-pharmacological treatments such as the CBT have been suggested to be useful in combating the persistent insomnia, the efficacy and clinical utility of CBT for primary insomnia have yet to be determined. METHOD: A systematic search of Ovid, MEDLINE, psychINFO, PsycARTICLES, CINAHL, and EMBASE databases of papers published between 1993 and 2004 was conducted, using the following medical subject headings or key words: insomnia, primary insomnia, psychophysiological insomnia, sleep maintenance disorders, sleep initiation disorders, non-pharmacological treatment, and cognitive behavioural therapy. A total of seven papers was included in the review. FINDINGS: Stimulus control, sleep restriction, sleep hygiene education and cognitive restructuring were the main treatment components. Interventions were provided by psychiatrists except for one study, in which the CBT was delivered by nurses. Among beneficial outcomes, improvement of sleep efficacy, sleep onset latency and wake after sleep onset were the most frequently reported. In addition, participants significantly reduced sleep medication use. Some studies gave follow-up data which indicated that the CBT produced durable clinical changes in total sleep time and night-time wakefulness. CONCLUSIONS: These randomized controlled trial studies demonstrated that CBT was superior to any single-component treatment such as stimulus control, relaxation training, educational programmes, or other control conditions. However, heterogeneity in patient assessment, CBT protocols, and outcome indicators made determination of the relative efficacy and clinical utility of the therapy difficult. Therefore, the standard components of CBT need to be clearly defined. In addition, a comprehensive assessment of patients is essential for future studies.

Adult↗

Insomnia is more common among subjects living in damp buildings.

BACKGROUND: Insomnia is a condition with a high prevalence and a great impact on quality of life. Little is known about the relation between and sleep disturbances and the home environment. AIM: To analyse the association between insomnia and building dampness. METHODS: In a cross-sectional, multicentre, population study, 16 190 subjects (mean age 40 years, 53% women) were studied from Reykjavik in Iceland, Bergen in Norway, Umeå, Uppsala, and Göteborg in Sweden, Aarhus in Denmark, and Tartu in Estonia. Symptoms related to insomnia were assessed by questionnaire. RESULTS: Subjects living in houses with reported signs of building dampness (n = 2873) had a higher prevalence of insomnia (29.4 v 23.6%; crude odds ratio 1.35, 95% CI 1.23 to 1.48). The association between insomnia and different indicators of building dampness was strongest for floor dampness: "bubbles or discoloration on plastic floor covering or discoloration of parquet floor" (crude odds ratio 1.96, 95% CI 1.66 to 2.32). The associations remained significant after adjusting for possible confounders such as sex, age, smoking history, housing, body mass index, and respiratory diseases. There was no significant difference between the centres in the association between insomnia and building dampness. CONCLUSION: Insomnia is more common in subjects living in damp buildings. This indicates that avoiding dampness in building constructions and improving ventilation in homes may possibly have a positive effect on the quality of sleep.

Adult↗

Insomnia in ischemic stroke patients.

This is the first study that focuses on insomnia in stroke patients. A subgroup of 277 patients from a consecutive series of 486 stroke patients aged 55-85 years was subjected to a comprehensive psychiatric evaluation 3-4 months after ischemic stroke. Of 277 patients, 56.7% reported any insomnia complaint and 37.5% fulfilled the DSM-IV criteria of insomnia. In 38.6%, insomnia complaint/insomnia had already been present prior to the stroke and in 18.1%, it was a consequence of the stroke. Independent correlates of any insomnia complaint/insomnia were anxiety (Zung Anxiety Scale) and the use of psychotropic drug. Independent correlates of poststroke-onset insomnia complaint/insomnia were disability after stroke (Barthel Index), dementia, anxiety and use of psychotropic drug. Insomnia should be taken into consideration in treating and rehabilitating stroke patients.

Aged↗

Prevalence, burden, and treatment of insomnia in primary care.

OBJECTIVE: The prevalence, burden, and management of insomnia among primary care patients were evaluated. METHOD: Consecutive patients aged 18 to 65 years in primary care clinics of a staff-model health maintenance organization (N = 1,962) were screened with the 12-item General Health Questionnaire. A stratified random sample (N = 373) completed face-to-face diagnostic assessments including the Composite International Diagnostic Interview, a brief self-rated disability questionnaire (Brief Disability Questionnaire), and the interviewer-rated Social Disability Schedule. A telephone follow-up survey was completed 3 months later. Use of psychotropic drugs, use of mental health services, and direct health care costs were assessed by using the health plan's automated data systems. RESULTS: Approximately 10% of the primary care patients reported major current insomnia (e.g., taking at least 2 hours to fall asleep nearly every night). Current insomnia was associated with significantly greater functional impairment (according to both Brief Disability Questionnaire and Social Disability Schedule), more days of disability due to health problems, and greater general medical service utilization. While insomnia was associated with depressive disorder and chronic medical illness, adjustment for these factors only partially accounted for the association of insomnia with disability and with health care utilization. Of the patients with current insomnia, 28% received any psychotropic drug; 14% received benzodiazepines and 19% received antidepressants. CONCLUSIONS: Insomnia among primary care patients is associated with greater functional impairment, lost productivity, and excess health care utilization.

Adult↗

Evaluation of insomnia and daytime napping in Iranian Alzheimer disease patients: relationship with severity of dementia and comparison with normal adults.

OBJECTIVE: Alzheimer disease (AD) is among the most common and disabling diseases in adulthood, and it has been largely neglected in traditional societies like Iran. Exacerbation of AD symptoms creates many severe problems, especially in traditional Iranian extended families. One of these problems is insomnia, which can very significantly affect patients' family members because of disturbing insomnia-related behaviors. METHODS: The authors studied 53 patients with probable AD who had been interviewed for dementia and depression in the Neurology Clinic of Roozbeh Psychiatric Hospital (Tehran University of Medical Sciences). Excluding patients with overlapping multi-infarct dementia, 35 AD patients (22 men, 13 women) and 21 adults without dementia were studied as a comparison group (11 men, 10 women). RESULTS: There was a significant relationship between duration of informant-reported symptoms and severity of dementia with daytime napping and more daytime napping among AD patients than in the comparison group. There was also a significant relationship between cognitive decline and daytime napping in the comparison group. Our study showed a relationship between insomnia and aggression, between daytime napping and paranoid delusions; and between onset of insomnia and anxiety. The comparison group showed a significant relationship between depression and daytime napping. CONCLUSIONS: Daytime napping and insomnia are very common among Iranian AD patients, much more so than in normal adults. There is also a significant relationship among psychiatric symptoms, daytime napping, and insomnia, but it seems that daytime napping and insomnia in depressed AD patients are caused more by the progress of AD than by depression.

Aged↗

Insomnia is a frequent finding in adults with Asperger syndrome.

BACKGROUND: Asperger syndrome (AS) is a neurodevelopmental disorder belonging to autism spectrum disorders with prevalence rate of 0,35% in school-age children. It has been most extensively studied in childhood while there is scarcity of reports concerning adulthood of AS subjects despite the lifelong nature of this syndrome. In children with Asperger syndrome the initiation and continuity of sleep is disturbed because of the neuropsychiatric deficits inherent of AS. It is probable that sleep difficulties are present in adulthood as well. Our hypothesis was that adults with AS suffer from difficulty in initiating and maintaining sleep and nonrestorative sleep (insomnia). METHODS: 20 AS without medication were compared with 10 healthy controls devoid of neuropsychiatric anamnesis. Clinical examination, blood test battery and head MRI excluded confounding somatic illnesses. Structured psychiatric interview for axis-I and axis-II disorders were given to both groups as well as Beck Depression Inventory and Wechsler adult intelligence scale, revised version.Sleep quality was assessed with sleep questionnaire, sleep diary during 6 consecutive days and description of possible sleep problems by the participants own words was requested. RESULTS: compared with controls and with normative values of good sleep, AS adults had frequent insomnia. In sleep questionnaire 90% (18/20), in sleep diary 75% (15/20) and in free description 85% (17/20) displayed insomnia. There was a substantial psychiatric comorbidity with only 4 AS subject devoid of other axis-I or axis-II disorders besides AS. Also these persons displayed insomnia. It can be noted that the distribution of psychiatric diagnoses in AS subjects was virtually similar to that found among patient with chronic insomnia. CONCLUSIONS: the neuropsychiatric deficits inherent of AS predispose both to insomnia and to anxiety and mood disorders. Therefore a careful assessment of sleep quality should be an integral part of the treatment plan in these individuals. Conversely, when assessing adults with chronic insomnia the possibility of autism spectrum disorders as one of the potential causes of this condition should be kept in mind.

Adult↗

DSM-IV and ICSD-90 insomnia symptoms and sleep dissatisfaction.

BACKGROUND: The complex nature of insomnia and its relationship with organic and mental disorders render diagnosis problematic for epidemiologists and physicians. METHOD: A representative UK sample (non-institutionalised, > 14 years old) was interviewed by telephone (n = 4972; 79.6% participation rate) with the Sleep-EVAL system. Subjects fell into three groups according to presence of insomnia symptom(s) and/or sleep dissatisfaction. RESULTS: Insomnia symptoms occurred in 36.2% of subjects. Most of these (75.9%), however, reported no sleep dissatisfaction. In comparison, those also with sleep dissatisfaction had higher prevalence of sleep and mental disorders and longer duration of insomnia symptoms, and were more likely to take sleep-promoting medication, dread bedtime, and complain of light sleep, poor night-time sleep and daytime sleepiness. CONCLUSIONS: Insomnia sufferers differ as to whether they are satisfied or dissatisfied with sleep. Although insomnia symptoms are common in the general population, sleep disturbances among sleep-dissatisfied individuals are more severe. Sleep dissatisfaction seems a better indicator of sleep pathology than insomnia symptoms.

Adolescent↗

Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects.

PURPOSE: Chronic insomnia is highly prevalent in cancer patients. Cognitive-behavioral therapy (CBT) is considered the treatment of choice for chronic primary insomnia. However, no randomized controlled study has been conducted on its efficacy for insomnia secondary to cancer. Using a randomized controlled design, this study conducted among breast cancer survivors evaluated the effect of CBT on sleep, assessed both subjectively and objectively, and on hypnotic medication use, psychological distress, and quality of life. PATIENTS AND METHODS: Fifty-seven women with insomnia caused or aggravated by breast cancer were randomly assigned to CBT (n = 27) or a waiting-list control condition (n = 30). The treatment consisted of eight weekly sessions administered in a group and combined the use of stimulus control, sleep restriction, cognitive therapy, sleep hygiene, and fatigue management. Follow-up evaluations were carried out 3, 6, and 12 months after the treatment. RESULTS: Participants who received the insomnia treatment had significantly better subjective sleep indices (daily sleep diary, Insomnia Severity Index), a lower frequency of medicated nights, lower levels of depression and anxiety, and greater global quality of life at post-treatment compared with participants of the control group after their waiting period. Results were more equivocal on polysomnographic indices. Therapeutic effects were well maintained up to 12 months after the intervention and generally were clinically significant. CONCLUSION: This study supports the efficacy of CBT for insomnia secondary to breast cancer.

Aged↗

Prevalence of insomnia symptoms in patients with sleep-disordered breathing.

OBJECTIVE: To assess the prevalence of insomnia symptoms in patients with objectively diagnosed sleep-disordered breathing (SDB). DESIGN: Retrospective medical chart review of a representative sample of patients with SDB. SETTING: University sleep-disorders clinic and laboratory. PATIENTS: Two hundred thirty-one patients with SDB were selected from a pool of approximately 2,000 patients with sleep disorders. MEASUREMENTS: Data were extracted from intake questionnaires and polysomnographic studies. RESULTS: Of 231 patients with SDB diagnoses, 115 patients reported no insomnia complaints (SDB-only patients) and 116 patients reported clinically meaningful insomnia complaints (SDB-plus patients). Compared to SDB-only patients, SDB-plus patients reported significantly worse mean sleep characteristics consistent with insomnia, including sleep latency (17 min vs 65 min), total sleep time (7.2 h vs 5.6 h), and sleep efficiency (92% vs 75%). SDB-plus patients experienced significantly more psychiatric disorders, cognitive-emotional symptoms, and physical and mental symptoms that disrupted or prevented sleep. SDB-plus patients also reported greater use of sedative and psychotropic medications and had significantly more primary complaints of insomnia, restless legs or leg jerks, and poor sleep quality despite having relatively similar referral rates for sleep apnea or complaints of loud snoring. CONCLUSIONS: Problematic insomnia symptoms were reported by 50% of a representative sample of patients with objectively diagnosed SDB. Research is needed to determine the degree to which insomnia and related symptoms and behaviors interfere with SDB treatment.

Adult↗

Patterns of sleep-related medications prescribed to elderly outpatients with insomnia in Taiwan.

OBJECTIVE: To explore prescription patterns and determinants of sleep-related medications prescribed to elderly outpatients with insomnia in Taiwan. METHODS: This cross-sectional study was based on 2001 annual outpatient claims data released by the Bureau of National Health Insurance in Taiwan. The claims data of each physician consultation were extracted and merged in one claim file. International Classification of Diseases (9th Edition)-Clinical Modification codes, patient's demographics, physician's specialty, the medical institution code and the content of pharmaceutical prescription constituted a file. Patients were included if they were: (i) > or =65 years of age; and (ii) coded as having 'insomnia'. RESULTS: Elderly insomniacs made up 216,994 of the 1,000,193 outpatient claim files we surveyed. Patients had a mean age of 74.33 years, and the sex distribution was nearly equal. Based on the data above, 11.14% of the elderly had been diagnosed as having 'insomnia' for the year 2001. This population preferred primary-care clinics over hospital-ambulatory departments; patients most frequently sought medical help from internal medicine specialists. The most popular sleep medication was lorazepam, followed by zolpidem. The first-choice off-label drug used to treat insomnia was trazodone. Hypnotics, sedatives and anxiolytics were prescribed 12.6 times more frequently than off-label used drugs. When treating insomnia with an off-label drug, physicians usually prescribed a therapeutic dosage much lower than that recommended in the package insert. Choice of sleep medication and off-label drug were most often influenced by physician specialty. Off-label prescriptions were common but not prevalent. Choice of hypnotic or sedative-anxiolytic was related to how long the drug acted and how much it cost; choice of off-label drug was related to physicians' familiarity with specific drugs and patients' characteristics. Concomitant anxiety or depression was significantly associated with higher consumption of hypnotics. CONCLUSIONS: Benzodiazepines and newer non-benzodiazepine hypnotics are still the most frequently used drugs for treating insomnia in the elderly in Taiwan. Elderly patients with concomitant anxiety or depression consumed more hypnotics. Further studies conducted over several years are needed to identify trends in the pharmacological treatment of insomnia.

Aged↗

Zopiclone. An update of its pharmacology, clinical efficacy and tolerability in the treatment of insomnia.

Zopiclone is a non-benzodiazepine hypnotic which was first reviewed in Drugs in 1986. At that time, zopiclone had shown hypnotic efficacy superior to that of placebo, but had not been extensively compared with benzodiazepine hypnotics in patients with insomnia. A much larger body of clinical data is now available, allowing a more detailed evaluation than was previously possible. Together with results from earlier studies, subsequent clinical trials have shown that zopiclone is generally at least as effective as the benzodiazepines (regardless of duration of action) in the treatment of insomnia, although comparisons between zopiclone and flurazepam have produced inconsistent results. Tolerance to the effects of zopiclone was not seen in short term clinical trials (< or = 4 weeks); data from longer term studies are conflicting and the potential for tolerance during long term zopiclone treatment is therefore unclear. Zopiclone has a relatively low propensity to cause residual clinical effects (such as difficulty in waking or reduced morning concentration). Rebound of insomnia to a level below that at baseline can occur after withdrawal of zopiclone, but, on the basis of data from short term studies, does not appear to be common. Data from prescription-event monitoring suggest that zopiclone does not have a high dependence potential (at least in those who are not regular drug abusers/addicts). Zopiclone is well tolerated in both the elderly and younger patients with insomnia. A bitter aftertaste is usually the most common adverse event, but is relatively infrequent (3.6% in the largest available postmarketing study). Thus, zopiclone is now firmly established as an effective and well tolerated hypnotic agent. Although the available data on rebound insomnia and dependence liability are encouraging, potential differences between zopiclone and the benzodiazepines in these respects may have little clinical relevance in the context of short term intermittent use of hypnotics, as it currently recommended. A low propensity for rebound insomnia and dependence might prove valuable during long term hypnotic therapy (which, although not recommended, is a clinical reality). However, the risk-benefit profile of zopiclone in this context remains unknown. Nevertheless, zopiclone is clearly a suitable alternative to the benzodiazepines for the short term treatment of insomnia.

Azabicyclo Compounds↗

The socioeconomic impact of insomnia. An overview.

Insomnia is an extremely common symptom both de novo and in the context of other medical and psychiatric disorders. The impact of insomnia is often ignored both by the individual and by society in terms of its clinical and socioeconomic ramifications. Insomnia is therefore under-appreciated and almost certainly under-treated, thus making it a serious health concern. It is estimated that more than 60 million Americans suffer from insomnia annually, and this figure is expected to grow to 100 million by the middle of the 21st century. Whether it be difficulty initiating or maintaining sleep, the disruption of nocturnal sleep will invariably impact on daytime activities and often results in daytime fatigue, performance deficits (including memory and other cognitive deficits), an increase in the number of sick days taken by an individual and accidents (some catastrophic). This review examines the costs directly related to insomnia in various sectors of healthcare, the indirect costs associated with accidents, sick days and decreased work productivity, and related costs resulting from insomnia but which meet neither the criteria of direct nor indirect cost categories. The total direct, indirect and related costs of insomnia are conservatively estimated at $US30 to 35 billion annually in the US (1994 dollars). Economic gains can be made by treating patients on an outpatient basis in sleep centres.

Absenteeism↗

Insomnia, health-related quality of life and healthcare resource consumption. A study of managed-care organisation enrollees.

OBJECTIVE: Insomnia is a prevalent sleep complaint which has been reported to be greatly associated with reduced health-related quality of life (HR-QOL) and increased healthcare resource use. This study documents the prevalence of insomnia, and its impact on patients' HR-QOL and healthcare resource use in managed-care settings in the US. DESIGN AND SETTING: A multi-site survey of 5 American Medical Group Association (AMGA) clinics was conducted. Each clinic mailed questionnaires to 1100 randomly selected individuals enrolled in its healthcare system and distributed questionnaires to 400 individuals during a clinic visit and prior to seeing a physician. The questionnaire was a form of the Health Status Questionnaire with the well-validated Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, a 3-question depression screen, a sleep questionnaire, demographic variables, and questions about medical encounters and prescription and over-the-counter (OTC) drug use. MAIN OUTCOME MEASURES AND RESULTS: Approximately one-third of managed-care enrollees in this study reported insomnia with daytime dysfunction. Individuals with insomnia reported lower HR-QOL scores and increased healthcare resource use compared with individuals with no insomnia. After controlling for demographic variable and comorbid conditions, the negative association of insomnia remained significant on all HR-QOL scores, emergency room visits, calls to the physician and OTC drug use. CONCLUSIONS: Insomnia is significantly associated with reduced HR-QOL and increased healthcare resource use in enrollees of managed-care organisations.

Health Care Surveys↗

Should anxiety and insomnia influence antidepressant selection: a randomized comparison of fluoxetine and imipramine.

BACKGROUND: The more sedating antidepressants are often recommended for patients presenting with anxiety or insomnia. We examine whether baseline anxiety or insomnia symptoms (1) show differential response to fluoxetine or imipramine or (2) predict differences between drugs in overall clinical response or likelihood of medication discontinuation. METHOD: 336 health maintenance organization primary care patients beginning antidepressant treatment for depression were randomly assigned to an initial prescription for fluoxetine or imipramine. All subsequent care (medication dosage, change, or discontinuation) was managed as usual by the primary care physician. The 17-item Hamilton Rating Scale for Depression (HAM-D) and the Hopkins Symptom Checklist (SCL) anxiety and depression subscales were administered prior to randomization and 1 month later. RESULTS: Rates of improvement in insomnia (HAM-D insomnia items), agitation (HAM-D agitation item), and anxiety (SCL anxiety subscale) were essentially identical in the two treatment groups. Baseline level of insomnia did not predict significant differences between randomization groups in improvement in overall HAM-D score (p = .44) or SCL depression subscale (p = .44). Similarly, baseline level of anxiety did not predict significant differences in improvement in HAM-D (p = .19) or SCL depression subscale (p = .31). Patients assigned to fluoxetine were significantly less likely to change or discontinue antidepressant medication during the first month, but this difference did not vary according to baseline level of insomnia (p = .68) or anxiety (p = .25). CONCLUSION: Among patients with moderate depression, baseline levels of insomnia or anxiety should not influence the choice of fluoxetine or imipramine as an initial antidepressant.

Adult↗

A review of the evidence for the efficacy and safety of trazodone in insomnia.

OBJECTIVE: Trazodone, a triazolopyridine antidepressant, is currently the second most commonly prescribed agent for the treatment of insomnia due to its sedating qualities. Given trazodone's widespread use, a careful review of the literature was conducted to assess its efficacy and side effects when given for treatment of insomnia. DATA SOURCES: In April 2003, a MEDLINE search was conducted using the search terms trazodone and insomnia and trazodone and sleep and restricted to 1980-2003, human subjects, and English language. As trazodone has been implicated in cardiac disorders, a further search was conducted using the term cardiac and trazodone. STUDY SELECTION: All clinical trials that measured any endpoint for insomnia efficacy were included in the assessment. A total of 18 studies were identified from the literature search. In addition, commonly used texts were consulted for information regarding adverse effects related to trazodone. DATA EXTRACTION: Because so few studies were identified by the literature search, all were evaluated and described. DATA SYNTHESIS: Evidence for the efficacy of trazodone in treating insomnia is very limited; most studies are small, conducted in populations of depressed patients, raise issues of design, and often lack objective efficacy measures. Side effects associated with trazodone are not inconsequential, with a high incidence of discontinuation due to side effects, such as sedation, dizziness, and psychomotor impairment, which raise particular concern regarding its use in the elderly. There is also some evidence of tolerance related to use of trazodone. CONCLUSION: Given the relative absence of efficacy data in patients with insomnia and the adverse events associated with trazodone's use in general, it is uncertain whether the risk/benefit ratio warrants trazodone's use in nondepressed patients with insomnia.

Adult↗

Managing insomnia in the primary care setting: raising the issues.

The optimal management of insomnia in the primary care setting should be viewed as a public health problem that will require specific attention. Important recent strides in the understanding of insomnia, its consequences, and its treatment do not always provide a basis for management strategies in a setting with distinct practical limitations. A somewhat different research focus will be needed if the scientific advances are to be translated into practical improvements in therapy. In primary care today, multiple agendas compete for the physician's time. Therefore, it is necessary to view diagnosis and management in terms of both what is efficient and what is optimally effective. Much can be learned from experience with medical risk factors of broad prevalence, such as hypercholesterolemia and hypertension. Large outcome trials demonstrating the benefits of drug therapy were required before pharmacologic management became standard care in the primary care setting. For insomnia, specific issues that must be addressed include the components of diagnosis that will guide therapy and affect prognosis. How can the 10% of adults with insomnia in the primary care practice be subdivided to identify those most in need of therapy? Stated another way, what are the features of insomnia that predict risk? Is duration important? Severity? Frequency? Which treatments are most effective? Which are most efficient in terms of the time required of patient and practitioner? Do treatments for insomnia produce patient satisfaction? Do they prevent adverse outcomes, such as depression and automobile accidents? Studies are now addressing many of these questions. In selecting research priorities, however, the practical application of this information in the clinical setting is important if the ultimate goal is to reduce the number of patients suffering from insomnia and its consequences.

Adult↗

Eight weeks of non-nightly use of zolpidem for primary insomnia.

CONTEXT: Intermittent use (i.e., a few nights per week) of hypnotic medication is often recommended for the treatment of chronic insomnia despite an absence of efficacy and safety data using this regimen. STUDY OBJECTIVES: To evaluate the clinical efficacy and safety of intermittent pharmacotherapy for chronic insomnia. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled, parallel groups, clinical trial at six sleep research sites. PATIENTS: One hundred-sixty-three (115 women, 48 men; mean age 44.1+ SE. 0.9 years), DSM-IV-defined primary insomnia patients were randomized, 134 patients completed the study. INTERVENTIONS: Eight weeks of treatment with either zolpidem 10 mg or placebo. Patients were instructed to take medication when they felt they needed it, but at least three and no more than five times per week. MAIN OUTCOME MEASURES: Investigator and Patient Global Ratings were the primary outcome variables. Secondary measures from daily questionnaires to assess efficacy, rebound insomnia and drug taking behavior. RESULTS: The Investigator's Global Rating indicated that intermittent use of zolpidem produced a significantly better therapeutic effect and significantly reduced insomnia severity throughout the 8-week study relative to placebo. Zolpidem was found to be effective in initiating and maintaining sleep on nights taken, as compared to placebo, based upon the Patient's Global Ratings and all subjective sleep variables. No evidence of rebound insomnia was found on nights that zolpidem was not taken. The number of nights a pill was taken did not differ between groups, nor did frequency of pill taking change in either group across the duration of the study. There were no significant effects of treatment upon quality of life or neurocognitive measures. CONCLUSIONS: Zolpidem 10 mg is effective in treating insomnia when used intermittently, without evidence of discontinuation effects or increased frequency of pill taking.

Analysis of Variance↗