制造商:
梅达制药
药理分类:
Imidazopyridine催眠
活性成分(补):
酒石酸唑吡坦5毫克,10毫克;舌下片。
指示(补):
失眠。
药理作用:
唑吡坦是催眠剂,通过与对GABA - BZ受体相互作用的复杂工程。尽管它的股票在不同的化学苯,巴比妥等催眠药物的药理作用苯一些。它选择性地结合到了一些,但并非所有的苯二氮受体亚型,这可能说明它的抗惊厥和肌肉松弛缺少属性。
舌下含服给药时,本产品溶解并吸收迅速。伴随粮食将推迟其效果。
临床试验:
两项临床研究进行了评估,在与唑吡坦治疗慢性失眠患者。双盲,平行组5周75成人门诊病人研究比较酒石酸唑吡坦2剂量和安慰剂。客观的测量表明,唑吡坦10毫克优于安慰剂对睡眠潜伏期,第4周,对睡眠几个星期2和4的效率。
在另一个成人门诊慢性失眠的研究中,唑吡坦10毫克优于对睡眠潜伏期为4周,所有的主观测量安慰剂,主观测量的总睡眠时间,觉醒数和睡眠质量的第一个星期的治疗。
在短暂治疗失眠,在一个正常成年人睡眠实验室进行了评估的第一个晚上在一个双盲,平行组比较,7.5mg和酒石酸唑吡坦10毫克安慰剂试验。研究药物两种剂量优于睡眠潜伏期,睡眠持续时间和数量的目标措施觉醒安慰剂。
在交叉涉及在5毫克,10毫克剂量,15毫克,20毫克和正常成人的68岁,平均年龄在经历短暂的失眠第2晚睡眠实验室,唑吡坦安慰剂进行了比较研究。剂量的唑吡坦均优于睡眠潜伏期,高效,持续时间,等待时间,质量和数量的觉醒安慰剂。
法律分类:
哀
成人:
≥18岁:舌头下放置1标签,并允许解散,不要采取与食物,水或酒精。睡前10毫克(只需要如果能够成为活跃起来之前得到7-8小时的睡眠)。老年,衰弱,或肝功能不全:在睡前服用5毫克。定期重新评估。
儿童:
<18年:不推荐。
警告/注意事项:
抑郁症。损害呼吸功能(例如,睡眠呼吸暂停)。条件,影响代谢或血液动力学反应。重症肌无力。写实际金额最小的接收。逐步撤出。老人。虚弱。劳动和交付。妊娠(Cat.C)。哺乳的母亲。
互动(补):
因酒精Potentiated,其他中枢神经系统抑制剂(如丙咪嗪,氯丙嗪),酮康唑(减少剂量唑吡坦)。可能受舍曲林,利福平,CYP3A的抑制剂。
不良反应(补):
中枢神经系统的影响(例如,幻觉,情绪激动,行为改变,人格解体,健忘),复杂睡眠相关行为(例如,睡眠驾驶),头痛,嗜睡,眩晕,过敏反应,血管性水肿;人。
如何提供:
sl的标签- 10,30,100
最后更新:
10/1/2009
Manufacturer:
Meda Pharmaceuticals
Pharmacological Class:
Imidazopyridine hypnotic
Active Ingredient(s):
Zolpidem tartrate 5mg, 10mg; sublingual tabs.
Indication(s):
Insomnia.
Pharmacology:
Zolpidem is a hypnotic agent that works by interacting with the GABA-BZ receptor complex. It shares some of the pharmacological effects of benzodiazepines despite being chemically dissimilar to the benzodiazepines, barbiturates, and other hypnotic agents. It selectively binds to some, but not all, of the benzodiazepine receptor subtypes, which may account for its lack of anticonvulsant and muscle relaxant properties.
When administered sublingually, this product dissolves and is absorbed rapidly. Concomitant food will delay its effect.
Clinical Trials:
Two clinical studies were conducted to evaluate zolpidem in the treatment of patients with chronic insomnia. A double-blind, parallel-group 5-week study in 75 adult outpatients compared 2 doses of zolpidem tartrate and placebo. Objective measurements indicated that zolpidem 10mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4.
In another study in adult outpatients with chronic insomnia, zolpidem 10mg was superior to placebo on a subjective measurement of sleep latency for all 4 weeks, and on subjective measurements of total sleep time, number of awakenings, and sleep quality for the first treatment week.
In the treatment of transient insomnia, normal adults in a sleep laboratory were evaluated on the first night in a double-blind, parallel-group trial comparing 7.5mg and 10mg of zolpidem tartrate to placebo. Both doses of the study drug were superior to placebo in objective measures of sleep latency, sleep duration, and number of awakenings.
In a crossover study involving normal adults with a mean age of 68 years experiencing transient insomnia during the first 2 nights in a sleep lab, zolpidem at doses of 5mg, 10mg, 15mg, and 20mg were compared to placebo. All of the zolpidem doses were superior to placebo for sleep latency, efficiency, duration, latency, quality, and number of awakenings.
Legal Classification:
CIV
Adults:
≥18 years: Place 1 tab under tongue and allow to dissolve; do not take with food, water, or alcohol. 10mg at bedtime (take only if able to get 7–8 hours of sleep before becoming active again). Elderly, debilitated, or hepatic impairment: 5mg at bedtime. Reevaluate periodically.
Children:
<18 years: not recommended.
Warnings/Precautions:
Depression. Compromised respiratory function (eg, sleep apnea). Conditions that affect metabolism or hemodynamic response. Myasthenia gravis. Write Rx for smallest practical amount. Withdraw gradually. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
Potentiated by alcohol, other CNS depressants (eg, imipramine, chlorpromazine), ketoconazole (reduce zolpidem dose). May be affected by sertraline, rifampin, CYP3A inhibitors.
Adverse Reaction(s):
CNS effects (eg, hallucinations, agitation, behavioral changes, depersonalization, amnesia), complex sleep-related behaviors (eg, sleep-driving), headache, drowsiness, dizziness, anaphylaxis, angioedema; others.
How Supplied:
SL tabs—10, 30, 100