Edluar(也叫Sublinox)是一种快速起效的舌下含服药剂，能暂时性治疗失眠症，该药物在舌下能经过口腔粘膜快速被吸收。
美国FDA批准Orexo公司的酒石酸唑吡坦（zolpidem tartrate，Edluar/Sublinox）舌下片上市，用于短期治疗难以入睡型失眠。本品剂量规格：5 mg/片、10 mg/片。辅料：甘露醇、微粉硅胶、硅化微晶纤维素、交联羧甲基纤维素钠、糖精钠和硬脂酸镁。
Orexo公司的合作伙伴美达（Meda）公司2008年从其处转让获得Edluar的全球销售权。本品是以Orexo公司的舌下释药制备技术制成，片剂置舌下药物可被口腔黏膜快速有效吸收。
酒石酸唑吡坦舌下片与酒石酸唑吡坦普通片（赛诺菲-安万特公司的Ambien）Cmax和AUC呈生物利用等效性。舌下片药物动力学释药图显示其药物吸收迅速。
18例（18～65岁）健康成人服用Edluar 10 mg 1片后，唑吡坦平均血药峰浓度（Cmax）为106 ng/mL（范围：52～205 ng/mL），达峰平均时间（Tmax）为82分钟（范围：30～180分钟）。

部分中文Edluar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)。

注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
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原产地英文商品名:
EDLUAR SL TABLET 5mg/tab 30tabs/box
原产地英文药品名:
ZOLPIDEM TARTRATE
中文参考商品译名:
乐坦舌下片 5毫克/片 30片/盒
中文参考药品译名:
酒石酸唑吡坦
生产厂家中文参考译名:
MEDA PHARMS
生产厂家英文名:
MEDA PHARMS

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原产地英文商品名:
EDLUAR SL TABLET 5mg/tab 30tabs/box
原产地英文药品名:
ZOLPIDEM TARTRATE
中文参考商品译名:
乐坦舌下片 5毫克/片 30片/盒
中文参考药品译名:
酒石酸唑吡坦
生产厂家中文参考译名:
MEDA PHARMS
生产厂家英文名:
MEDA PHARMS

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Edluar
Marketed by: Meda Pharmaceuticals Inc (Somerset, NJ)
Indication: Meda Pharmaceuticals announced the commercial availability of Edluar (zolpidem tartrate sublingual tablets). Edluar is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep. Edluar is the first available under-the-tongue formulation of zolpidem tartrate, the active ingredient in Ambien oral tablets, and the most prescribed treatment for insomnia.

Dosage Form: Tablets: 5 and 10 mg
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Edluar
Generic Name: zolpidem (zole PI dem)
Brand Names: Ambien, Edluar
What is Edluar?
Edluar (zolpidem) is a sedative, also called a hypnotic. Zolpidem affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).
Edluar sublingual tablets are used for the short treatment of insomnia where individuals are finding it difficult to fall asleep.
Edluar sublingual tablets may also be used for other purposes not listed in this medication guide.
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Important information about Edluar
Edluar sublingual tablets may cause a severe allergic reaction. Stop taking the tablets 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. Edluar 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 Edluar and talk with your doctor about another treatment for your sleep disorder.
Edluar 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 Edluar. It can increase some of the side effects of zolpidem, including drowsiness. Edluar may be habit-forming and should be used only by the person it was prescribed for. This medicine 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.
Before taking Edluar
Edluar 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 Edluar and talk with your doctor about another treatment for your sleep disorder.
Do not use this medication if you are allergic to zolpidem.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Edluar:
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; ora history of drug or alcohol addiction.
FDA pregnancy category C. It is not known whether Edluar is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use Edluar without telling your doctor if you are breast-feeding a baby.
See also: Pregnancy and breastfeeding warnings in more detail
The sedative effects of Edluar 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 Edluar.
Do not give this medicine to anyone younger than 18 years of age.
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How should I take Edluar?
Take Edluar sublingual tablets exactly as they were 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.
The Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed whole and the tablet should not be taken with water. Ask your doctor or pharmacist if you have any questions.
Take Edluar 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.
Edluar 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 this medicine for longer than 4 or 5 weeks without your doctor's advice.
You may have withdrawal symptoms if you stop taking Edluar after taking it over several days in a row. Do not stop taking Edluar 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 Edluar. 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 Edluar.
Store Edluar sublingual tablets at room temperature away from moisture and heat.
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What happens if I miss a dose?
Since Edluar 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 Edluar can be fatal when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
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What should I avoid while taking Edluar?
Edluar 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 Edluar 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 Edluar.
Do not drink alcohol while you are taking Edluar. It can increase some of the side effects of zolpidem, including drowsiness
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Edluar side effects
Edluar may cause a severe allergic reaction. Stop taking Edluar 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 Edluar 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, changes in personality.
Less serious Edluar 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Edluar side effects in more detail
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What other drugs will affect Edluar?
You may need a lower dose of Edluar 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 Edluar, tell your doctor about all other medications you use, especially:
chlorpromazine (Thorazine);
itraconazole (Sporanox), ketoconazole (Nizoral);
rifampin (Rifadin, Rimactane, Rifater); or
antidepressants such as imipramine (Janimine, Tofranil), or sertraline (Zoloft).
This list is not complete and there may be other drugs that can interact with Edluar. 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 Edluar.
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