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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: 1毫克/片 30片/盒
计价单位:
   
生产厂家中文参考译名:
Sunovion
生产厂家英文名:
Sunovion
该药品相关信息网址1:
http://www.lunesta.com/
该药品相关信息网址2:
http://www.drugs.com/lunesta.html
该药品相关信息网址3:
http://www.rxlist.com/lunesta-drug.htm
原产地英文商品名:
LUNESTA 1mg/tab 30tabs/box
原产地英文药品名:
ESZOPICLONE
原产地英文化合物名称:
[(5S)-6-(5-chloropyridin -2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo(3,4-b) pyrazin-5-y14-methylpiperazine-l-carboxylate]
中文参考商品译名:
LUNESTA 1毫克/片 30片/盒
中文参考药品译名:
艾司佐匹克隆
中文参考化合物名称:
(+)- (5S)-6-(氯吡啶2-甲酰基)-7-氧-6,7-二氢-5氢-吡咯[3,4-b] 吡嗪-5-甲酰基4-甲基哌嗪-1-羧酸盐
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Sleep Disorders
临床试验期:
完成
中文适应病症参考翻译1:
睡眠障碍
药品信息:

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 详细处方信息以本药内容附件PDF文件(201011323230520.pdf)的“原文Priscribing Information”为准
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部分中文艾司佐匹克隆处方资料(仅供参考)

    艾司佐匹克隆(eszopiclone)为非苯二氮卓类催眠药,商品名为Lunesta ,曾用名Estorra。由美国马萨诸塞州Sepracor制药公司生产,2004年12月16日美国 FDA批准用于临床。
    本品为环毗咯的吡咯吡嗪衍生物。化学名称为(+)- (5S)-6-(氯吡啶2-甲酰基)-7-氧-6,7-二氢-5氢-吡咯[3,4-b] 吡嗪-5-甲酰基4-甲基哌嗪-1-羧酸盐。英文化学名[(5S)-6-(5-chloropyridin -2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo(3,4-b) pyrazin-5-y14-methylpiperazine-l-carboxylate]。
    艾司佐匹克隆相对分子质量为388.81,分子式为C17H17CIN6O3。
    本品为白色或微白色结晶,微溶于水、乙醇和磷酸盐缓冲液(pH3.2)。
    艾司佐匹克隆准确的药理作用仍未知,其催眠作用与 GABA受体有关。

1、药动学
    本品口服吸收迅速,达峰浓度时间(tmax)约1h,消除半衰期约6h,蛋白结合率较低(52%~59%),在体内代谢广泛,主要代谢产物为(S)-佐匹克隆-N-氧化物和(S)-N-去甲基佐匹克隆,后者与GABA受体的结合力比艾司佐匹克隆弱,前者与GABA受体无结合力。研究表明,CYP3A4和 CYP2E1酶参与本品的代谢。约10%的艾司佐匹克隆以原形从尿中排泄。食物不影响本品的吸收。

2、临床评价
    在由Zammit等进行的一项随机、双盲、多中心对照研究中,308例成人失眠患者接受安慰剂或艾司佐匹克隆治疗(2或3 mg)连续44个夜晚,以多导睡眠记录仪(PSG)(第1,巧和29夜)和患者的主观陈述(第1,15,29和43或44夜)来评价,次日的残留作用用数字符号替换测验(DSST)来评价。结果表明,艾司佐匹克隆3 mg与安尉剂比较,其入睡时间明显减少(P<0.001),总的睡眠时间延长(尸<0.001),睡眠质量明显改善(P<0.01),睡眠质量和深度增加(P<0.05)。艾司佐匹克隆2 mg与安尉剂比较其人睡时间也明显减少(P< 0.001),总的睡眠时间延长(P<0.01),睡眠质量和深度增加(P<0.05),但睡眠持续没有明显改善。艾司佐匹克隆在治疗中断后没有反跳性失眠。DSST分值表明患者的精神运动行为与基线相比没有减少,与安慰剂没有差异。
    在Rosenbe唱等进行的随机、双盲、安慰剂对照研究中,436例健康、正常睡眠者使用短暂失眠模型,接受1,2,3, 3.5 mg或安慰剂治疗,受试者用PSG, DSST以及患者的主观陈述来评价。结果表明,本品与安慰剂比较,患者的觉醒时间(所有剂量,P<0.05)、觉醒次数(3和3.5 mg,P<0.005)、睡眠效率(所有剂量,P≤0.02)均有明显改善。
    KTy5tal等进行的一项随机、双盲、多中心对照研究中,入组的患者(21~69岁)符合DSM-W失眠诊断标准,用本品(n=593)或安慰剂(n=195)治疗6个月,每周应用交互式语音应答系统(IVRS)来评价,终点包括睡眠潜伏期、总睡眠时间、苏醒次数、睡眠启动后觉醒时间、睡眠质量等,结果表明,本品在睡眠潜伏期、睡眠启动后觉醒时间、觉醒次数、每周夜间觉醒次数、总睡眠时间、睡眠质量方面与安慰剂相比有明显和持续的改善(P≤0.03)。白昼功能量表也明显优于安慰剂组(P≤0.02)。

3、适应证
    艾司佐匹克隆可用于入睡困难,夜间维持睡眠困难、早醒等不同类型的睡眠障碍。

4、用法用量
    艾司佐匹克隆应个体化给药。对于大多数成年患者的起始剂量为睡前给予2~3 mg,对于老年患者建议起始剂量为1~2 mg。有严重肝功能损害者的起始剂量为1 mg,对于与CYP3A4抑制剂合用者,起始剂量不应该超过1 mg.老年患者服用本品的起始剂量不应超过2 mg。肝功能异常者应慎用本品。严重肝功能异常者服用本品不应超过2 mg。肾功能异常者无需调节剂量。

5、药物不良反应
    艾司佐匹克隆有较好的耐受性,常见的不良反应是味觉异常、头晕、胸痛、偏头痛。本品不产生依赖性,很少引起记忆损害。

6、药物相互作用
    本品与帕罗西汀、地高辛和华法林之间无相互作用。本品与奥氮平合用时不改变相互之间的药动学。劳拉西洋合用时两者的ρmax可减少22%。本品当本品与CYP3A4抑制剂酮康唑合用时,可增加本品的ρmax2.2倍。本品不改变由 CYP450酶系统代谢的药物的清除率。

7、剂型与规格
    片剂:1 mg;2 mg;3 mg。

Lunesta
Generic Name: eszopiclone (e ZOP i klone)
Brand Names: Lunesta

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

Lunesta is used to treat insomnia. This medication causes relaxation to help you fall asleep and stay asleep.

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

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What is the most important information I should know about Lunesta?
Lunesta may cause a severe allergic reaction. Stop taking Lunesta 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. Lunesta will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 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 Lunesta and talk with your doctor about another treatment for your sleep disorder.

Lunesta 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 Lunesta, including drowsiness. Lunesta may be habit-forming and should be used only by the person it was prescribed for. Lunesta 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.

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

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What should I discuss with my healthcare provider before taking Lunesta?
Lunesta will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 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 this medication and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to eszopiclone.
Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:
liver disease;
sleep apnea (breathing stops while you are asleep);
lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
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 Lunesta.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Lunesta 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.
The sedative effects of Lunesta 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 Lunesta.

Lunesta may be habit-forming and should be used only by the person it was prescribed for. Lunesta 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.

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How should I take Lunesta?
Take this medication 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.

Take Lunesta 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 at least 8 hours to dedicate to sleeping.

Take this medication with a full glass of water.

Avoid taking Lunesta within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.

Lunesta 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 Lunesta for longer than 2 weeks without your doctor's advice.

You may have withdrawal symptoms if you stop taking Lunesta 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.

Store this medication at room temperature away from moisture and heat. Keep track of how many capsules have been used from each new bottle of this medicine. Lunesta is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

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What happens if I miss a dose?
Since Lunesta is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have at least 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. Symptoms of an Lunesta overdose are not known.

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What should I avoid while taking Lunesta?
Lunesta 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 Lunesta. It can increase some of the side effects of Lunesta, including drowsiness. Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

Avoid taking Lunesta 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 at least 8 hours of sleep after taking Lunesta.

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Lunesta side effects
Lunesta may cause a severe allergic reaction. Stop taking Lunesta 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 Lunesta and call your doctor at once if you have any of these serious side effects:
aggression, agitation, changes in behavior;
thoughts of hurting yourself; or
hallucinations (hearing or seeing things).

Less serious side effects may include:
day-time drowsiness, dizziness, "hangover" feeling;
problems with memory or concentration;
anxiety, depression, nervous feeling;
headache;
nausea, stomach pain, loss of appetite, constipation;
dry mouth;
unusual or unpleasant taste in your mouth; or
mild skin rash.

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.

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What other drugs will affect Lunesta?
Before taking Lunesta, tell your doctor if you are taking any of the following drugs:
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
ketoconazole (Nizoral); or
antidepressants, narcotic pain medications, muscle relaxers, seizure medications, or anti-anxiety medications.

This list is not complete an there may be other drugs that can interact with Lunesta. 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 Lunesta.

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What does my medication look like?
Eszopiclone is available with a prescription under the brand name Lunesta. 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.

Lunesta 1mg - round, light blue, film-coated tablets.
Lunesta 2mg - round, white, film-coated tablets.
Lunesta 3mg - round, dark blue, film-coated 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 drugs, 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(201011323230520.pdf)的“原文Priscribing Information”为准
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更新日期: 2015-01-06
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