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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/片 30片/瓶
计价单位:
  点击放大  
该药品相关信息网址1:
http://www.rxlist.com/ambien-drug.htm#ad
该药品相关信息网址2:
http://www.drugs.com/ambien.html
原产地英文商品名:
ZOLPIDEM TARTRATE(AMBIEN GENERIC) 5mg/tablet 30tablets/bottle
原产地英文药品名:
ZOLPIDEM TARTRATE
中文参考商品译名:
酒石酸唑吡坦(诺宾仿制药) 5毫克/片 30片/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:
1992/12/16
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(201051021492728.pdf)的“原文Priscribing Information”为准
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部分中文Zolpidem Tartrate
处方资料(仅供参考)

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)。  

Ambien
Generic Name: zolpidem (zole PI dem)
Brand Names: Ambien, Edluar

What is Ambien?
Ambien is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Ambien is used for the short-term treatment of insomnia (difficulty falling or staying asleep). This medication causes relaxation to help you fall asleep.

Ambien may also be used for purposes other than those listed in this medication guide.

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Important information about Ambien
Ambien may cause a severe allergic reaction. Stop taking it and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Ambien will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder.

Ambien can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not drink alcohol while you are taking this medication. It can increase some of the side effects of Ambien, including drowsiness. This medication may be habit-forming and should be used only by the person it was prescribed for. Ambien should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

It is dangerous to try and purchase Ambien on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of this medication purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S.

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What should I discuss with my healthcare provider before taking Ambien?
Ambien will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to zolpidem. Ambien tablets may contain lactose. Use caution if you are sensitive to lactose.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease;
liver disease;
lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
sleep apnea (breathing stops during sleep);
myasthenia gravis;
a history of depression, mental illness, or suicidal thoughts; or
a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Ambien.

FDA pregnancy category C. It is not known whether zolpidem is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings in more detail

The sedative effects of Ambien may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking Ambien.

Do not give this medicine to anyone younger than 18 years of age

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How should I take Ambien?
Take Ambien exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ambien comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take Ambien only if you are able to get a full night's sleep before you must be active again. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Take this medication with a full glass of water. Avoid taking Ambien CR with or just after a meal or it may take longer for you to fall asleep. Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take Ambien for longer than 4 or 5 weeks without your doctor's advice.

You may have withdrawal symptoms if you stop taking this medication after taking it over several days in a row. Do not stop taking this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Withdrawal symptoms include behavior changes, stomach pain, muscle cramps, nausea, vomiting, sweating, anxiety, panic, tremors, and seizure (convulsions). Insomnia symptoms may also return after you stop taking this medication. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking Ambien.

Do not crush, chew, or break an Ambien CR tablet. Swallow the tablet whole. It is specially made to release medicine slowly in the body. Breaking the tablet would cause too much of the drug to be released at one time. Do not swallow the Edluar tablet whole. Place it under your tongue and allow it to dissolve in your mouth without water. Store zolpidem at room temperature away from moisture and heat.

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What happens if I miss a dose?
Since Ambien is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have a full 7 to 8 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Ambien can be fatal when it is taken together with other medications that can cause drowsiness.

Symptoms of a Ambien overdose may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

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What should I avoid while taking Ambien?
Ambien can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.

Do not drink alcohol while you are taking Ambien. It can increase some of the side effects of Ambien, including drowsiness

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Ambien side effects
Ambien may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Ambien and call your doctor at once if you have any of these serious side effects:
depressed mood, thoughts of hurting yourself;
unusual thoughts, risk-taking behavior, decreased inhibitions, no fear of danger;
anxiety, aggression, feeling restless or agitated;
hallucinations, confusion, loss of personality.
Less serious Ambien side effects may include:
daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
lack of coordination;
amnesia, forgetfulness;
vivid or abnormal dreams;
nausea, constipation;
stuffy nose, sore throat;
headache, muscle pain; or
blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Ambien side effects in more detail

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What other drugs will affect Ambien?
You may need a lower dose of Ambien if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.

Before taking Ambien, tell your doctor about all other medications you use, especially:
chlorpromazine (Thorazine);
itraconazole (Sporanox), ketoconazole (Nizoral);
rifampin (Rifadin, Rimactane, Rifater);
antidepressants such as imipramine (Janimine, Tofranil) or sertraline (Zoloft); or

This list is not complete and there may be other drugs that can interact with Ambien. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about Ambien.

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What does my medication look like?
Zolpidem is available with a prescription under the brand name Ambien. Other brand or generic formulations of this medication may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Ambien 5 mg - pink, capsule-shaped, film-coated tablets
Ambien 10 mg - white, capsule-shaped, film-coated tablets
Ambien CR 6.25 mg - pink round controlled release tablets

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drgs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist

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 详细处方信息以本药内容附件PDF文件(201051021492728.pdf)的“原文Priscribing Information”为准
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更新日期: 2011-12-29
附件:


201051021492728.PDF    

 
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