扎来普隆治疗失眠症的疗效及安全性：随机双盲对照研究

目的：评价国产二类新药扎来普隆治疗失眠症的临床疗效及安全性。方法：采用随机、双盲双模拟、平行对照方法。受试者分别每晚口服扎来普隆或唑吡坦10～20mg，疗程14d。结果：扎来普隆组24例，唑毗坦组23例，两组治疗后的睡眠障碍评定量表评分(SDRS)均较治疗前显著降低，两组间SDRS总分(F=0.1416，P=0.8880)、SDRS下降率(F=1.3172，P=0.1944)差异均无显著性意义。治疗总有效率分别为扎来普隆组72％，唑吡坦组58％，两组差异无显著性意义(X^2=0.9150，P=0.3602)。两组的不良反应主要有头昏、恶心、头痛，发生率差异无显著性意义。结论：扎来普隆可明显改善失眠症状，其疗效及不良反应与唑吡坦相似，是一种安全、有效的治疗成人失眠的药物。     

扎来普隆治疗失眠症的疗效及安全性:随机双盲对照研究

目的:评价国产二类新药扎来普隆治疗失眠症的临床疗效及安全性。方法:采用随机、双盲双模拟、平行对照方法。受试者分别每晚口服扎来普隆或唑吡坦10～20mg,疗程14d。结果:扎来普隆组24例,唑吡坦组23例,两组治疗后的睡眠障碍评定量表评分(SDRS)均较治疗前显著降低,两组间SDRS总分(F=0.1416,P=0.8880)、SDRS下降率(F=1.3172,P=0.1944)差异均无显著性意义。治疗总有效率分别为扎来普隆组72%,唑吡坦组58%,两组差异无显著性意义(χ2=0.9150,P=0.3602)。两组的不良反应主要有头昏、恶心、头痛,发生率差异无显著性意义。结论:扎来普隆可明显改善失眠症状,其疗效及不良反应与唑吡坦相似,是一种安全、有效的治疗成人失眠的药物。     

扎莱普隆胶囊治疗失眠症的随机双盲对照试验

【目的】评价国产扎莱普隆胶囊治疗失眠症的有效性和安全性。【方法】采用随机、双盲、双模拟、阳性药平行对照研究。48例失眠症患者随机分为试验组（24例）与对照组（24例），分别口服扎莱普隆胶囊10mg／d或唑吡坦片10mg／d，疗程14d，观察两组疗效及不良反应。【结果】睡眠障碍量表（SDRS）评分在治疗结束时两组较基线均显著减少（P〈0．01）；试验组有效率为58．3％，对照组有效率为45．5％，两组比较差异无显著性（P〉0．05）。扎来普隆较常见的不良反应为头晕、口苦、口干，未出现严重的不良反应。【结论】扎莱普隆胶囊为安全而有效的催眠药物。     

小儿尿道下裂修复术后舒芬太尼镇痛的最低有效剂量

摘要: 目的 探讨舒芬太尼静脉输注用于小儿尿道修复术后镇痛的最低有效剂量。方法 纳入2～4岁行尿道下裂修复手术的小儿,在吸入诱导下行单次骶管阻滞（0.25％罗哌卡因1ml/kg），术中静脉输注丙泊酚（50ug•kg-1•min-1）维持小儿镇静。静脉注射舒芬太尼0.1ug/kg后，静脉通路连接镇痛泵，以2ml/h速度持续输注舒芬太尼，采用改良序贯法选择舒芬太尼剂量。盲法评估小儿术后1h、4h、8h、24h、48h疼痛和镇静，并记录不良反应。结果 共观察40例小儿，仅有1例术后8h出现轻度恶心，没有发生呼吸抑制和皮肤瘙痒。舒芬太尼剂量为2 ug•kg-1•d-1、1 ug•kg-1•d-1和0.75 ug•kg-1•d-1时，所有小儿镇痛效果良好。舒芬太尼剂量为0.5 ug•kg-1•d-1时，术后有4例小儿需要追加镇痛药物。结论 2～4岁小儿尿道下裂修复术后，舒芬太尼静脉镇痛的最低有效剂量为0.75 ug•kg-1•d-1。关键词：舒芬太尼；术后镇痛；儿童；尿道下裂修复术     

国产扎来普隆治疗失眠症的随机双盲双模拟多中心临床研究

目的：本研究对重庆华邦制药股份有限公司研制的扎来普隆胶囊治疗失眠症的临床疗效和安全性进行多中心临床研究。对象与方法：符合CCMD-3失眠症(非器质性失眠症)标准的自愿受试患者：采用以佐匹克隆片为对照的双盲双模拟多中心随机对照临床试验设计,治疗期2周,疗效观察指标包括睡眠障碍量表(Sleep Dysfunction Rating Scale,SDRS)和临床总体印象表(CGI);安全性评价采用治疗药物副作用量表(TESS),并在治疗前后检查血、尿常规,肝肾功能,心电图。结果：216例受试完成了试验,扎来普隆组的有效率73．33％、佐匹克隆组78．95％,二者差别无统计学意义。扎来普隆组不良反应出现率为11．97％,佐匹克隆组不良反应出现率为39.83％,差异具有显著性(P=0．001)。扎来普隆组不良反应主要表现为口干7．69％,口苦1．71％,嗜睡1．71％,便秘1．71％,扎来普隆组肝肾功能、心电图未出现有临床意义的改变。     

唑吡坦联合生物反馈对失眠症患者睡眠质量和心理健康水平疗效的影响

探讨唑吡坦联合生物反馈对失眠症患者睡眠质量和心理健康水平疗效的影响。2015年6月~2016年6月选择失眠症患者60例为研究对象,随机分为研究组和对照组各30例。对照组给予唑吡坦口服治疗,研究组在此基础上给予生物反馈治疗。比较治疗前后两组睡眠质量及心理健康水平评分。两组治疗后睡眠质量评分及心理健康评分均较治疗前显著改善,差异有统计学意义(P0.05);研究组治疗后睡眠质量及心理健康评分显著低于对照组,差异有统计学意义(P0.05)。唑吡坦联合生物反馈对失眠症患者能显著改善患者睡眠质量及心理健康水平。     

枣仁安神胶囊联合酒石酸唑吡坦治疗失眠的疗效观察

目的 探讨枣仁安神胶囊联合酒石酸唑吡坦治疗失眠的临床疗效。方法 收集医院就诊失眠患者53例,随机分成四组,分别为A组:枣仁安神胶囊(5粒/d)+酒石酸唑吡坦(5 mg/d);B组:枣仁安神胶囊模拟剂(5粒/d)+酒石酸唑吡坦(5 mg/d);C组:枣仁安神胶囊模拟剂(5粒/d)+酒石酸唑吡坦(10 mg/d);D组:枣仁安神胶囊(5粒/d)+酒石酸唑吡坦模拟剂(10 mg/d)。均睡前30 min服用。治疗4周。治疗前与治疗结束后均使用匹兹堡睡眠质量指数(PSQI)、失眠严重程度指数(ISI)、汉密尔顿抑郁量表(HAA4D)、汉密尔顿焦虑量表(HAMA)、大脑皮层电生理特征参数进行评估。结果 四组治疗后ISI、PSQI及HAMA量表评分均低于治疗前,且差异有统计学意义(P<0.05)。B、C、D三组治疗后HAMD量表评分均低于治疗前,且差异有统计学意义(P<0.05)。ISI减分率:C组>A组>D组>B组,差异无统计学意义(P>0.05);PSQI减分率:C组>A组>D组>B组,除B组与C组之间差异有统计学意义(P<0.05)...     

艾司西酞普兰联合唑吡坦治疗原发性失眠的临床疗效和安全性评价

目的:探讨艾司西酞普兰联合唑吡坦治疗原发性失眠症的临床效果。方法:选取2018年7月至2020年4月青岛优抚医院收治的原发性失眠症患者40例作为研究对象,按照用药方式不同分为对照组和观察组,每组20例。对照组采用常规西药治疗,观察组采用艾司西酞普兰联合唑吡坦治疗。比较2组治疗效果。结果:观察组的治疗效果明显高于对照组,差异有统计学意义。结论:给予原发性失眠患者应用艾司西酞普兰联合唑吡坦药物的治疗,可有效改善患者的睡眠质量水平,拥有一定的安全相关,值得推广。     

针灸联合西药对原发性失眠症患者睡眠质量的影响

目的：分析针灸联合西药治疗原发性失眠症的疗效及对患者睡眠质量的影响。方法：选取2021年8月至2022年8月就诊于福建中医药大学附属福州中医院的60例原发性失眠症患者,按随机对照原则分为对照组与研究组。对照组30例采用酒石酸唑吡坦片治疗;研究组30例采用酒石酸唑吡坦片联合针灸治疗,两组均治疗4周。对比两组临床疗效、不良反应发生情况,治疗前、治疗4周后睡眠质量、过度觉醒状态、血清神经递质水平。结果：研究组总有效率为93.33%,高于对照组的73.33%,差异有统计学意义（P<0.05）;治疗4周后研究组失眠严重程度指数（ISI）、匹兹堡睡眠质量指数（PSQI）、入睡前觉醒量表（PSAS）、过度觉醒量表（HAS）评分低于对照组（P<0.05）;治疗4周后研究组总睡眠时间长于对照组,睡眠潜伏时间、觉醒次数优于对照组（P<0.05）;治疗4周后研究组血清谷氨酸（GA）、γ-氨基丁酸（GABA）水平高于对照组（P<0.05）;研究组出现2例轻微局部血肿,所有患者治疗期间均未出现过敏、感染、晕针等严重不良反应。结论：针灸联合西药治疗原发性失眠症患者的效果明显,可提高患者睡眠...     

腰硬联合麻醉前预充对剖宫产患者血压及恶心呕吐、寒颤发生率的影响

目的: 观察预充乳酸林格氏液对腰硬联合麻醉（CSEA）下剖宫产术中患者血压及呕吐、房颤发生率的影响。方法: 60例拟在CSEA下行剖宫产产妇，随机分为两组，实验组(R 组，n=30)于麻醉前30 min内输完乳酸林格氏液500ml，然后再以5ml/kg&#8226;h继续输注乳酸林格氏液，对照组(C 组，n=30)则直接以5ml/kg&#8226;h静脉输注乳酸林格氏液，观察两组患者麻醉前、麻醉后5min、10 min、20min、手术结束时的收缩压（SBP）、舒张压(DBP)变化和发生恶心呕吐及寒颤的情况。结果: 两组产妇麻醉前血压无差别，麻醉后5min、10min时实验组血压明显高于对照组（P<0.05），20min后两组血压无显著差异；实验组恶心呕吐发生率明显低于对照组（P<0.05）；两组寒颤发生率无明显差别。结论：麻醉前预充可以使剖宫产产妇术中血压相对稳定，降低恶心呕吐的发生率。     

Treatment of insomnia in hospitalized patients.

OBJECTIVE: To provide recommendations for the short-term management of insomnia in hospitalized patients and review patient assessment, nonpharmacologic treatment modalities, and selection of hypnotic medications. DATA SOURCES: Review articles and primary literature representative of current knowledge regarding the treatment of insomnia were identified by MEDLINE search (1966-January 2001). Search terms included insomnia (sleep initiation and maintenance disorders), benzodiazepines, zaleplon, zolpidem, and trazodone. DATA SYNTHESIS: Literature regarding the management of insomnia in hospitalized patients is limited; therefore, data pertinent to the treatment of ambulatory patients must be extrapolated to the inpatient setting. When evaluating insomnia in hospitalized patients, it seems reasonable to obtain a thorough history and physical examination to identify potential underlying etiologies. Treatment of these underlying etiologies should be considered. When the use of a sedative-hypnotic agent is necessary, medication and dose selection should be based on the pharmacokinetic and adverse effect profiles of each agent. Patent-specific characteristics should also be considered to provide effective treatment while minimizing adverse effects. CONCLUSIONS: Nonpharmacologic approaches to the treatment of insomnia should be considered for hospitalized patients. When sedative-hypnotic medications must be administered, the pharmacokinetic profile of intermediate-acting benzodiazepines (e.g., lorazepam, temazepam) makes them good first-line agents. Zaleplon and zolpidem are also attractive hypnotic agents; however, they are typically reserved for second-line therapy due to cost. Trazodone may be an alternative for patients unable to take benzodiazepines.     

Zaleplon: a pyrazolopyrimidine sedative-hypnotic agent for the treatment of insomnia

BACKGROUND: Insomnia is the subjective complaint of poor sleep or an inadequate amount of sleep that adversely affects daily functioning. For the past 4 decades, treatment of insomnia has shifted away from the use of barbiturates toward the use of hypnotic agents of the benzodiazepine class. However, problems associated with the latter (eg, next-day sedation, rebound insomnia, dependence, and tolerance) have prompted development of other agents. OBJECTIVE: This review describes the recently approved nonbenzodiazepine agent, zaleplon. METHODS: Studies of zaleplon were identified through a search of English-language articles listed in MEDLINE and International Pharmaceutical Abstracts, with no limitation on year. These were supplemented by educational materials from conferences. RESULTS: The efficacy and tolerability of zaleplon have been documented in the literature. Zaleplon has been shown to improve sleep variables in comparison with placebo. Like most hypnotic agents, zaleplon can be used for problems of sleep initiation at the beginning of the night, but its short duration of clinical effect may also allow patients to take it later in the night without residual effects the next morning. Zaleplon can be taken < or = 2 hours before awakening without "hangover" effects. It is generally well tolerated, with headache being the most commonly reported adverse event in clinical trials (15%-18%). Compared with flurazepam, a long-acting benzodiazepine sedative-hypnotic agent, zaleplon causes significantly less psychomotor and cognitive impairment (P < 0.001). Zaleplon has not been studied in pregnant women or children. The dose of zaleplon should be individualized; the recommended daily dose for most adults is 10 mg. CONCLUSIONS: Insomnia has a substantial impact on daily functioning. If pharmacologic treatment is indicated for insomnia, the choice of an agent should be guided by individual patient characteristics.     

Treatment options for insomnia

The frequency of sleep disruption and the degree to which insomnia significantly affects daytime function determine the need for evaluation and treatment. Physicians may initiate treatment of insomnia at an initial visit; for patients with a clear acute stressor such as grief, no further evaluation may be indicated. However, if insomnia is severe or long-lasting, a thorough evaluation to uncover coexisting medical, neurologic, or psychiatric illness is warranted. Treatment should begin with nonpharmacologic therapy, addressing sleep hygiene issues and exercise. There is good evidence supporting the effectiveness of cognitive behavior therapy. Exercise improves sleep as effectively as benzodiazepines in some studies and, given its other health benefits, is recommended for patients with insomnia. Hypnotics generally should be prescribed for short periods only, with the frequency and duration of use customized to each patient's circumstances. Routine use of over-the-counter drugs containing antihistamines should be discouraged. Alcohol has the potential for abuse and should not be used as a sleep aid. Opiates are valuable in pain-associated insomnia. Benzodiazepines are most useful for short-term treatment; however, long-term use may lead to adverse effects and withdrawal phenomena. The better safety profile of the newer-generation nonbenzodiazepines (i.e., zolpidem, zaleplon, eszopidone, and ramelteon) makes them better first-line choices for long-term treatment of chronic insomnia.     

Hypnotics in Insomnia: The Experience of Zolpidem

PurposeOne of the most commonly prescribed medications to treat insomnia is zolpidem, a nonbenzodiazepine compound that is available as an immediate-release oral tablet formulation, an extended-release oral formulation, an oral spray formulation, and as sublingual formulations. The purpose of this review was to summarize the data currently available on the efficacy and safety of zolpidem in the treatment of insomnia among adults.MethodsPublished studies on the use of zolpidem in the treatment of insomnia were identified by using combinations of relevant search terms in PubMed and Google Scholar. Studies were included if they were placebo- or active comparator–controlled studies, with the exception of trials on the long-term use of zolpidem. Studies were limited to those conducted in adults. Studies were not included if the patient population was small, if the study was not designed or powered to assess the efficacy or safety of zolpidem, if insomniac patients had a medical condition in addition to insomnia (with the exception of comorbid depression or anxiety for studies on comorbid insomnia), or if zolpidem was given concomitantly with any other therapy (with the exception of selective serotonin reuptake inhibitors for studies on comorbid insomnia).FindingsTwenty-five studies designed to evaluate the efficacy of zolpidem in insomnia and 51 studies reporting the safety of zolpidem in insomnia were included in this review.ImplicationsThe studies discussed in this review report the efficacy and safety of zolpidem in both young adults and the elderly. It can be used for either bedtime or middle-of-the-night administration, over the short or long term, with minimal risk of withdrawal or abuse. The use of zolpidem is associated with rebound insomnia, complex sleep-related behaviors, and next-day residual effects (after middle-of-the-night dosing) on driving ability, memory, and psychomotor performance.     

Double-blind, dose-range-finding study of fleroxacin (RO 23-6240; AM-833) for treatment of complicated urinary tract infections.

In a double-blind randomized trial, we evaluated the efficacy and safety of three oral dosage regimens of fleroxacin, a new fluoroquinolone, once daily in 62 patients for the treatment of complicated urinary tract infections. The regimens compared were 200 mg for 10 days (n = 20), 400 mg for 10 days (n = 21), and 600 mg for 10 days (n = 21). Forty-five patients were evaluable for efficacy. A clinical cure was reached in 78% of the patients. Overall, a favorable bacteriological response (negative culture or reinfection at 4 to 6 weeks) was obtained in 36 of 45 (80%) patients. No significant difference could be found among the three dosage groups. During therapy, one Klebsiella ozaenae strain became resistant and one Pseudomonas aeruginosa strain became less susceptible to fleroxacin. In 13 patients, therapy had to be discontinued due to major adverse events (oliguria [n = 1], psychosis [n = 1], photosensitivity [n = 1], insomnia [n = 1], and nausea [n = 9]). Minor side effects were seen in 13 other patients. Increased dosage correlated significantly (P less than 0.01) with total number of adverse events.     

Pharmacokinetics, pharmacodynamics, and relative pharmacokinetic/pharmacodynamic profiles of zaleplon and zolpidem

OBJECTIVE: This study compared the pharmacokinetics, pharmacodynamics, and pharmacokinetic/pharmacodynamic (PK/PD) profile of zaleplon, a new pyrazolopyrimidine hypnotic, with those of zolpidem and placebo. METHODS: This was a double-blind, 5-period crossover study in which healthy volunteers with no history of sleeping disorder were randomized to 10- or 20-mg oral doses of zaleplon, 10- or 20-mg oral doses of zolpidem, or placebo. The pharmacokinetic characteristics of the active drugs were estimated using a noncompartmental method and NONMEM. Pharmacodynamic characteristics were determined using psychophysical tests, including measures of sedation, mood, mental and motor speed, and recent and remote recall. Results of these tests were used to compare the drugs' relative PK/PD profiles. RESULTS: Ten healthy male and female volunteers, aged 23 to 31 years, took part in the study. The apparent elimination half-life of zaleplon (60.1+/-8.9 min) was significantly shorter than that of zolpidem (124.5+/-37.9 min) (P < 0.001). Zaleplon produced less sedation than zolpidem at the 2 doses studied (P < 0.001). The sedation scores of the zaleplon groups returned to baseline in less time than those of the zolpidem groups (4 vs 8 hours; P < 0.05). Zaleplon had no effect on recent or remote recall, whereas zolpidem had a significant effect on both measures (P < 0.05). CONCLUSIONS: In this study in 10 young, healthy volunteers, zaleplon was eliminated more rapidly, produced no memory loss, and caused less sedation than zolpidem at the same doses.     

Eszopiclone (Lunesta), a new hypnotic

Eszopiclone (Lunesta) is effective for treatment of insomnia for at least 6 months, with no evidence of tolerance, dependence or abuse. It has caused mild, transient memory impairment in some patients. No studies are available comparing eszopiclone with similar drugs like zolpidem (Ambien) or zaleplon (Sonata).     

Eszopiclone, a nonbenzodiazepine sedative-hypnotic agent for the treatment of transient and chronic insomnia

OBJECTIVE: This paper reviews the pharmacologic and pharmacokinetic properties, clinical efficacy, and safety profile of the nonbenzodiazepine cyclopyrrolone agent eszopiclone in the management of adult patients with insomnia. METHODS: Recent studies, abstracts, reviews, and consensus statements published in English were identified through searches of MEDLINE (1966-December 2005), International Pharmaceutical Abstracts (1970 December 2005), and PharmaProjects (1990-December 2005) using the search terms eszopiclone, cyclopyrrolone, insomnia, nonbenzodiazepine, and zopiclone enantiomer. Selected information provided by the manufacturer of eszopiclone was included, as were all pertinent clinical trials. RESULTS: Eszopiclone is rapidly absorbed after oral administration, with Tmax achieved within approximately 1 hour and a terminal-phase elimination half-life of approximately 6 hours. Approximately 52% to 59% of a dose is weakly bound to plasma protein. Eszopiclone is extensively metabolized by oxidation and demethylation. In vitro studies have indicated that the cytochrome P450 (CYP) isozymes CYP3A4 and CYP2E1 are involved in the biotransformation of eszopiclone; therefore, drugs that induce or inhibit these CYP isozymes may affect the metabolism of eszopiclone. Eszopiclone is excreted in the urine as racemic zopiclone at <10% of the orally administered dose. Six Phase III clinical trials were identified that evaluated the safety profile and efficacy of eszopiclone, 1 in healthy subjects with transient insomnia and 5 in patients with primary chronic insomnia (3 in younger adults and 2 in the elderly). In the trials in younger adults, eszopiclone significantly improved sleep efficiency, sleep latency, wake time after sleep onset, number of awakenings, number of nights awakened weekly, total sleep time, and quality and depth of sleep compared with placebo (P<0.05). In the trials in elderly patients, who received eszopiclone 2 mg or placebo for 2 weeks, eszopiclone was associated with significantly shorter sleep latency compared with placebo (P<0.004), as well as a significant decrease in the cumulative number of naps (P<0.05). The most commonly reported drug-related, dose-responsive adverse event in clinical trials of eszopiclone 2 and 3 mg was bitter taste (17% and 34%, respectively), followed by dizziness (5% and 7%) and dry mouth (5% and 7%). Somnolence occurred at an incidence of 4% to 9% with both doses. Tolerance or rebound insomnia was not reported. CONCLUSIONS: Eszopiclone represents an effective and well-tolerated option for the treatment of insomnia. In the absence of published studies comparing eszopiclone with similar hypnotic agents (eg, zolpidem, zaleplon, zopiclone), it is not yet possible to evaluate its efficacy relative to other agents used for insomnia.     

Discriminative stimulus effects of benzodiazepine (BZ)(1) receptor-selective ligands in rhesus monkeys.

Drug discrimination was used to examine the effects of benzodiazepine (BZ)(1) receptor-selective ligands in rhesus monkeys. In diazepam-treated (5.6 mg/kg, p.o.) monkeys discriminating the nonselective BZ antagonist flumazenil (0.32 mg/kg, s.c.), the BZ(1)-selective antagonist beta-carboline-3-carboxylate-t-butyl ester (beta-CCt) substituted for flumazenil. The onset of action of beta-CCt was delayed with a dose of 5.6 mg/kg beta-CCt substituting for flumazenil 2 h after injection. In monkeys discriminating the nonselective BZ agonist midazolam (0.56 mg/kg, s.c.), the BZ(1)-selective agonists zaleplon (ED(50) = 0.78 mg/kg) and zolpidem (ED(50) = 1.73 mg/kg) substituted for midazolam. The discriminative stimulus effects of midazolam, zaleplon, and zolpidem were antagonized by beta-CCt (1.0-5.6 mg/kg, s.c.), and the effects of zaleplon and zolpidem were also antagonized by flumazenil (0.01-0.32 mg/kg, s.c.). Schild analyses supported the notion of a simple, competitive interaction between beta-CCt and midazolam (slope = -1.08; apparent pA(2) = 5.41) or zaleplon (slope = -1.57; apparent pA(2) = 5.49) and not between beta-CCt and zolpidem. Schild analyses also were consistent with a simple, competitive interaction between flumazenil and zaleplon (slope = -1.03; apparent pA(2) = 7.45) or zolpidem (slope = -1.11; apparent pA(2) = 7.63). These results suggest that the same BZ receptor subtype(s) mediate(s) the effects of midazolam, zolpidem, and zaleplon under these conditions and that selective binding of BZ ligands does not necessarily confer selective effects in vivo.     

Eszopiclone for insomnia

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy data, and adverse effects of eszopiclone in the treatment of transient and chronic insomnia in adult and geriatric patients. DATA SOURCES: A MEDLINE literature search (1966-May 2005) was conducted to retrieve articles and abstracts involving eszopiclone. The manufacturer of the drug provided a general summary of clinical data and abstracts of unpublished Phase III clinical trials. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were reviewed, and information deemed relevant was included for this review. DATA SYNTHESIS: Food and Drug Administration approval of eszopiclone was based on 6 double-blind, placebo-controlled trials. Five trials published in abstract or study form were reviewed. The sixth trial was not available for evaluation. An open-label continuation trial was also reviewed. All studies showed statistically significant improvements in sleep parameters in adult and elderly patients treated for insomnia with eszopiclone. CONCLUSIONS: The results of the 5 available double-blind, placebo-controlled studies (and 1 open-label, 6-month extension) showed that eszopiclone was safe and effective in the treatment of transient and chronic insomnia in adult and geriatric patients. Tolerance with long-term exposure (6 mo) and rebound insomnia were not observed. The results of the 6-month, open-label extension trial demonstrated that improvements in sleep parameters were sustained. Future studies comparing eszopiclone with other non benzodiazepine sedative-hypnotics (eg, zolpidem, zaleplon) are needed with cost data to clearly define the role of eszopiclone in the pharmacotherapy of chronic insomnia.