INTERMEZZO
Manufacturer:
Purdue Pharma L.P.
Pharmacological Class:
Imidazopyridine hypnotic.
Active Ingredient(s):
Zolpidem tartrate 1.75mg, 3.5mg; sublingual tablets.
Indication(s):
As needed use for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Not indicated for treatment of middle-of-the-night insomnia when the patient has <4 hours of bedtime remaining before the planned time of waking.
Pharmacology:
Zolpidem is a GABAA agonist hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ complex and shares some of the pharmacological properties of the benzodiazepines.
Clinical Trials:
Intermezzo was evaluated in two randomized, double-blind, placebo-controlled studies in patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night (MOTN) awakening. In these studies, patients met the diagnosis for primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) and had at least three prolonged MOTN awakenings per week that were at least 30 minutes in duration.
Eighty-two adult patients aged 19–64 years (58 females, 24 males) were evaluated in a double-blind, placebo-controlled, 3-period cross-over sleep laboratory study. The primary outcome measure was latency to persistent sleep. Doses of 3.5mg and 1.75mg of Intermezzo significantly decreased both objective (by polysomnography) and subjective (patient-estimated) sleep latency after a scheduled MOTN awakening as compared to placebo. The effect on sleep latency was similar for females receiving 1.75mg of Intermezzo and males receiving 3.5mg of Intermezzo.
Two hundred ninety-five adult patients aged 18–64 years (201 females, 94 males) were evaluated in a double-blind, placebo-controlled 4-week outpatient study of Intermezzo. Patients took study drug (3.5mg of Intermezzo or placebo) on an as needed (prn) basis. Subjective (patient-estimated) time to fall back to sleep after MOTN awakening was significantly shorter for Intermezzo 3.5mg compared to placebo.
Legal Classification:
CIV
Adults:
Place 1 tab under the tongue and allow to disintegrate completely before swallowing. ≥18 years: 1.75mg (women) or 3.5mg (men) (take only once per night if needed and only if at least 4 hours of bedtime remain before the planned time of waking). Concomitant CNS depressants, elderly (≥65 years), hepatic impairment: 1.75mg (men and women). Effect delayed if taken with or immediately after a meal.
Children:
<18 years: not recommended.
Warnings/Precautions:
Risk of CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses (eg, physical and/or psychiatric disorders) prior to treatment. Reevaluate if insomnia persists after 7–10 days of use. Monitor for new onset behavioral changes, worsening of depression, or suicidal thinking. Compromised respiratory function. Sleep apnea. Myasthenia gravis. Hepatic impairment. Drug or alcohol abusers. Write Rx for smallest practical amount. Elderly. Pregnancy (Cat. C). Nursing mothers.
Interaction(s):
Additive effects with concomitant other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, imipramine, chlorpromazine or alcohol); reduce dose. Concomitant with other sedative-hypnotics including other zolpidem products: not recommended. Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole). Reduced exposure by CYP3A4 inducers (eg, rifampin).
Adverse Reaction(s):
Headache, nausea, fatigue; CNS effects, abnormal thinking, complex sleep-related behaviors (eg, sleep-driving), anaphylaxis, angioedema, others (see literature).
How Supplied:
Sublingual tabs—30
制造商：
普渡制药L.P.版权所有
类药物：
Imidazopyridine催眠。
活性成分（S）：
酒石酸唑吡坦1.75mg，3.5mg，舌下含片。
指示（S）：
治疗失眠需要使用时，中间的返回入睡困难，夜间觉醒。不表示治疗中等晚上失眠时，病人有<睡前4小时前剩余计划的时间醒来。
药理作用：
唑吡坦是一种GABAA受体激动剂催眠剂的化学结构与苯二氮卓类，巴比妥类，其他药物或与知名催眠属性。一氨基丁酸的渤复杂和股份苯二氮卓类药物的药理特性与交互。
临床试验：
间奏曲在两项随机，双盲，安慰剂对照研究的特点是中间的夜（MOTN）觉醒后睡觉困难失眠患者进行了评估。在这些研究中，患者符合诊断为原发性失眠定义为精神疾病诊断与统计手册（DSM-IV-TR），每周至少有三个的长期MOTN觉醒，在时间至少30分钟。
一项双盲，安慰剂对照，3周期交叉睡眠实验室研究中，82个成人患者年龄在19-64岁（58位女性，24名男性）进行了评估。主要结果测量是持久性睡眠的潜伏期。间奏曲3.5mg和1.75mg剂量显着降低后，预计MOTN觉醒与安慰剂相比，既有客观的（多导睡眠监测）和主观（患者估计）睡眠潜伏期。睡眠潜伏期的作用是接收间奏曲1.75mg女性和男性接受间奏曲3.5mg类似。
在一项双盲，安慰剂对照4周间奏曲门诊研究，两百九十五名成人年龄在18-64岁的患者（201名女性，94名男性）进行了评估。患者服用研究药物（间奏曲或者安慰剂3.5mg）需要（PRN）为基础。主观（患者估计）MOTN觉醒后回落到睡觉的时间明显缩短间奏曲3.5mg安慰剂相比。
法律分类：
持续输注
成人：
地方1标签下舌头，让吞咽前完全瓦解。 ≥18岁：1.75mg（女）或3.5mg（男）（每晚只有一次如果需要的话，只有睡前至少4小时前计划的时间醒来仍然）。伴随中枢神经系统抑制剂，老年人（≥65岁），肝功能不全：1.75mg（男性和女性）。影响延迟，如果与或饭后立即采取。
儿童：
<18岁：不推荐。
警告/注意事项：
中枢神经系统抑制作用，并在第二天减值的风险。共病诊断（例如，物理和/或精神障碍）治疗前的评估。重新评估，如果失眠持续使用后7-10天。监测的新发生行为改变抑郁症的恶化，或自杀想法。损害呼吸功能。睡眠呼吸暂停。重症肌无力。肝功能损害。药物或酒精滥用。接收写为最小的实际金额。老人。怀孕（部件）。哺乳的母亲。
互动（补）：
伴随其他中枢神经系统抑制剂（如苯二氮卓类药物，阿片类药物，三环类抗抑郁药，丙咪嗪，氯丙嗪或酒精）的累加效应;减少剂量。伴随着其他镇静催眠药包括其他唑吡坦的产品：不推荐。 Potentiated由强力CYP3A4抑制剂（如酮康唑）。 CYP3A4诱导剂（如利福平）减少曝光。
不良反应（S）：
头痛，恶心，疲劳;中枢神经系统的影响，思维异常，复杂的睡眠相关的行为（例如，睡眠驾驶），过敏反应，血管神经性水肿，其他人（见文献）。
如何提供：
舌下标签-30
最后更新：
2012年4月5日
