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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->催眠药物
处方药:处方药
包装规格: 5毫克/喷 7.7毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
NovaDel
生产厂家英文名:
NovaDel
该药品相关信息网址1:
http://www.novadel.com/pipeline/zolpimist.htm
该药品相关信息网址2:
http://www.drugs.com/zolpimist.html
该药品相关信息网址3:
http://www.rxlist.com/zolpimist-drug.htm
原产地英文商品名:
ZOLPIMIST ORAL SPRAY 5MG/SPRAY 7.7ML/BTL
原产地英文药品名:
ZOLPIDEM TARTRATE
中文参考商品译名:
ZOLPIMIST口服喷剂 5毫克/喷 7.7毫升/瓶
中文参考药品译名:
酒石酸唑吡坦
原产地国家批准上市年份:
2008/12/19
英文适应病症1:
Short-term treatment of insomnia
临床试验期:
完成
中文适应病症参考翻译1:
失眠症的短期治疗
药品信息:

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 详细处方信息以本药内容附件PDF文件(2011122823040222.pdf,2011122823035324.PDF)的“原文Priscribing Information”为准
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部分中文Zolpimist处方资料(仅供参考)

Zolpimist批准用於短时候掉眠治疗
    食品药物办理局(FDA)批准一种处圆用心折喷剂Zolpimist,露有安眠药物Ambien的活性成分,用於难以进眠者的短时候掉眠治疗。
  制制Zolpimist的NovaDel药厂来日诰日发表新闻稿指出FDA的这项批准,FDA发止人借出有提出回应。
  NovaDel药厂表示,心折喷剂结果比锭剂快速,且没有需供喝水服药,可改良病患的便当性与顺从性,且Zolpimist的结果战Ambien锭剂相当。
  NovaDel药厂的新闻稿中表示,果为Zolpimist 感化敏捷,病患须於睡前当即便用,且准备好拥有完整的就寝时间(7至8小时)。
  根据NovaDel药厂指出,Zolpimist 临床试验中最常见的副感化是头痛、嗜睡与头昏目炫。
  利用Zolpimist时要谨慎利用其他的助眠剂。中药知识
  举例来说,NovaDel药厂警告病患,正在服药隔天要相当谨慎重视制止需供齐神贯注的活动,比方驾驶或操纵危险机械;同时,利用Zolpimist期间,如果思惟或止为上有任何异常改变时要当即便医。

中文正式名:酒石酸唑吡坦

商品名及别名:乐坦 诺宾 思诺思 左吡登 唑吡坦

英文名:Zolpidem Tartrate

主要成分:本品主要成分及其化学名称为:本品的主要成分是酒石酸唑吡坦,其化学名为N,N,6-三甲基-2-(4-甲基苯基)-咪唑并[1,2-a]吡啶-3-乙酰胺酒石酸盐。

分子式及分子量:分子式:C19H21N3O2?C4H6O6;分子量:764.88

药理学特征:本品为一催眠剂,通过选择性地与中枢神经系统的ω1-受体亚型的结合,产生药理作用。本品小剂量时,能缩短入睡时间,延长睡眠时间;在较大剂量时,第2相睡眠、慢波睡眠(第3和第4相睡眠)时间延长,REM睡眠时间缩短。

药代学特征:据文献报道,酒石酸唑吡坦吸收快,起效迅速。口服生物利用度为70%,且在治疗剂量范围内显示线性动力学,口服后0.3~3小时血药浓度达峰值。消除半衰期,平均为2.4小时(0.7~3.5),作用可维持6小时。血浆蛋白结合率为92.5%±0.1%。肝的首过效应为35%。重复服药不改变蛋白结合率,表明本品与其代谢物对结合部位缺乏竞争。成人的表观分布容积为0.54±0.2L/kg。老年人降至0.34±0.052L/kg。所有代谢物均无活性,且由尿中(56%)和粪便中(37%)排出。试验表明唑吡坦是不可透析的。

作用与用途:失眠症的短期治疗

服用方法:本品起效迅速,所以应在临睡前服用。成人的推荐剂量为每天10mg。老年人和体质虚弱者可能对本品较敏感,因此推荐剂量为第天5mg。
    对于肝功能不全者,本品的清除代谢率降低,应从每天5mg剂量开始服用,对老年病人应特别注意。疗程可由几天至两周不等,最多四周(包括逐渐减量的时间)。注意,不得超过推荐和疗程服用。

不良反应:有证据表明,服用本品有与剂量相关的不良反应,尤其是对中枢神经系统的作用和胃肠蠕动增加。老年病人最易产生。临床试验中,10mg剂量以下观察到的不良反应有:嗜睡、头晕、头痛、恶心、腹泻和眩晕。
    在长期临床试验中,极少观察到记忆障碍(顺行性遗忘),夜间烦躁,抑郁综合症、精神障碍、意识障碍或复视、颤抖舞蹈步和跌倒。
    使用苯二氮卓类或类似苯二氮卓类药物会出现如下副作用:烦躁、兴奋、过敏性、侵略性错觉、暴怒、梦魇、幻觉、精神病、过激行为和其他敌对行为。如出现这些症状,应停止用药。年老者更易出现这些症状。

禁忌症:
    1、对本品过敏者禁用。
    2、梗阻性睡眠呼吸暂停综合征、重症肌无力、严重肝功能不全、急性呼吸功能不全伴呼吸抑制者禁用,抑郁型精神病患者慎用。

注意事项:
    1、连续服用速效的苯二氮卓类和类似苯二氮卓类药物几周后,其药效和催眠效果可能会有所降低,而产生耐受性。
    2、依赖性和失眠症反弹:依赖性:使用苯二氮卓类和类似苯二氮卓类药物可能会对这些药物产生躯体和精神依赖性。产生依赖性的风险随剂量的增加及治疗期的延长而增加。具有滥用药物和酗酒史者风险更大。一旦出现身体依赖性,立即停药会出现戒断症状,包括头痛、肌肉痛、极度焦虑紧张、烦躁、兴奋和谵妄。严重时会出现意识障碍、失去理智、听觉过敏、麻木、四肢麻刺感,对光、声音和身体接触过敏、出现幻觉和癫痫发作。
    失眠症反弹:由苯二氮卓类和类似苯二氮卓类药物引起的短暂综合症状可能会使失眠症复发并增强。停止安眠治疗可能出现失眠症反弹。也可能伴随其它症状,包括情绪不稳、焦虑和烦躁。由于突然停药,会出现戒断症状或失眠症反弹,故应逐渐减少剂量。
    3、对驾车和操作机械能力的影响:虽然研究表明服用本品后,模拟车辆驾驶未受影响,但司机和机械操作者应注意,同别的催眠药一样,服用本品次日上午可能有睡意。

孕妇及哺乳
    妇女用药:妊娠及哺乳期妇女禁用。
    儿童用药:15岁以下儿童禁用。

药物相互作用:不宜同时饮酒,因酒精可能增强镇静效果,影响驾驶或操作机械能力。慎与中枢神经系统镇静剂合用:与抗精神病药(神经安定药)、催眠药、抗焦虑药、麻醉止痛药、抗癫痫药和有镇静作用的抗组胺药合用,能增强中枢抑制作用。不宜与抗抑郁药合用。
    麻醉止痛剂可能会增强欣快症,从而导致精神依赖性增加。
    抑制肝酶(特别是细胞色素P450)的化合物可能会增强苯二氮卓类或类似类苯二氮卓类药的作用。

药物过量:在过量用药病例中,有由意识障碍、嗜睡到轻度昏迷的报告。应进行全身检查和解救措施,如立即洗胃,必要时给予支持疗法等。当洗胃无效时,应使用活性碳减少吸收。即使出现兴奋,也要禁止使用镇静药物。出现严重症状时,可考虑使用氟马西尼(Flumazenil)。  

Zolpimist™
Zolpimist™ (zolpidem oral spray) uses NovaDel’s proprietary formulation technology to deliver zolpidem tartrate, which is currently marketed as Ambien®, the leading hypnotic for the treatment of insomnia.  NovaDel has announced positive results from its clinical studies comparing zolpidem oral spray with Ambien® tablets.  Zolpimist™ has been approved by the FDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Zolpimist™ offers the potential benefit of a faster rise in drug blood levels potentially leading to a faster onset of action, without having to take water.

Novadel's North American licensee is currently finalizing commercialization plans for this new product.

Clinical Studies
The Company has completed three clinical studies comparing Zolpimist™ to Ambien® tablets.  The two pivotal studies are described below:

NVD003  – Healthy volunteers with mean age of 29 years
Study NVD003 compared 5 mg and 10 mg doses of Zolpimist™ with comparable doses of Ambien® tablets.  Pursuant to FDA guidance in this type of 4-way crossover study, all data were compared to the highest marketed dose, which in this study was the 10 mg Ambien® tablet.  Positive results from the study demonstrated that NovaDel’s 10 mg and 5 mg Zolpimist™ achieved bioequivalence with 10 mg Ambien® tablets, the primary standard of reference for this study.

A secondary assessment of the relationship between speed of drug absorption and the attainment of  therapeutic drug levels showed 79% of subjects using the 10 mg Zolpimist™ reached therapeutic levels at 15 minutes post-dosing while only 26% of subjects using 10 mg tablets reached therapeutic levels at that time point. The results were statistically significant.

NVD004 – Healthy, elderly volunteers with mean age of 71 years
Study NVD004 compared doses of 5 mg Zolpimist™ to 5 mg Ambien® tablets. The primary objective of the study was to demonstrate comparability/bioequivalence of pharmacokinetics between oral spray and tablet groups.

A secondary assessment of the relationship between speed of drug absorption and the attainment of therapeutic drug levels showed 65% of subjects using the 5 mg Zolpimist™ reaching therapeutic levels at 15 minutes post-dosing while only 19% of subjects in the tablet group reached therapeutic levels by 15 minutes. The results were statistically significant.

Current Status
Zolpimist™ has been approved by the FDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation.  NovaDel is seeking a partner for commercialization in regions other than North America.

Zolpimist™ for Middle-of-the-Night Awakenings (MOTN)

Clinical studies have demonstrated that a low dose of zolpidem is effective in treating a sub-set of insomnia patients who wake up during the night and have difficulty falling back asleep.  NovaDel has begun development of a lower dose version of Zolpimist™ with the intent of performing clinical trials to demonstrate the benefit of an easy-to-use oral spray form of zolpidem in this important and large patient population.

About Insomnia
Insomnia is a sleep disorder whose sufferers experience inadequate or poor quality sleep and report one or more of the following: difficulty initiating sleep, difficulty maintaining sleep, and waking up too early. According to the “2005 Sleep in America Poll,” 54% of those surveyed indicated they experience at least one symptom of insomnia a few nights per week. Approximately one third of insomniac suffer from middle-of-the-night awakenings.  Only approximately 14% of the respondents reported using any sort of sleep-aid therapy. Walsh and Engelhardt (1999) estimated $14 billion is spent each year on the direct costs of insomnia, including pharmaceuticals, healthcare services and hospital and nursing home care. Cowen & Company estimated the total non-benzodiazepine prescription market in the U.S. for the treatment of insomnia in 2007 was approximately $3.4 billion, growing to $3.8 billion by 2011. Ambien®/Ambien CR™ (zolpidem tartrate) are the dominant products with approximately 80% of the market in 2006. The patent on Ambien® has expired and generic products were recently introduced.

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 详细处方信息以本药内容附件PDF文件(2011122823040222.pdf,2011122823035324.PDF)的“原文Priscribing Information”为准
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更新日期: 2011-12-29
附件:




2011122823040222.pdf    

2011122823035324.PDF    

 
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