美国食品与药物管理局（FDA）批准Intermezzo (酒石酸唑吡坦舌下片)用于治疗夜间醒后难以再入睡的失眠症。
这是FDA第一次批准用于上述情况的药物。Intermezzo应仅用于仍可睡眠4个小时或以上的患者。如果患者饮酒或用了其他睡眠辅助措施，则不应使用该药。
酒石酸唑吡坦最初于1992年在美国获准。Intermezzo是唑吡坦的小剂量配方。推荐的最大剂量Intermezzo在女性为1.75 mg，在男性为3.5 mg，每晚一次。由于女性的唑吡坦体内清除率低于男性，因此，女性的推荐剂量较小。
两项纳入370例病人的临床试验对Intermezzo进行了研究。研究显示，与服用安慰剂的病人相比，服用Intermezzo的病人醒后再次入睡的时间较短。最常见的不良反应是头痛、恶心和乏力。
与其他安眠药类似，Intermezzo有可能引起严重的副作用，包括在未完全清醒时跌下床，无意识的活动，或忘记自己所做的事。据报告，当在睡眠药影响下从事一些活动（开车、做饭和进食、性活动、打电话和梦游）时，患者当时会不知道在做什么或事后无记忆。如果患者饮酒或服用了其他睡眠药，则发生上述行为的机会增加。
Intermezzo属于联邦政府控制的药物，因其可能被滥用或导致依赖。
INTERMEZZO
Generic Name and Formulations:
Zolpidem tartrate 1.75mg, 3.5mg; sublingual tablets.
Company:
Purdue Pharma L.P.
Indications for INTERMEZZO:
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 patient has <4 hours of bedtime remaining before planned time of waking.
Adult Dose for INTERMEZZO:
Place 1 tab under the tongue and allow to disintegrate completely before swallowing. ≥18yrs: 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 (≥65yrs), hepatic impairment: 1.75mg (men and women). Effect delayed if taken with or immediately after a meal.
Children's Dose for INTERMEZZO:
<18yrs: not recommended.
Pharmacological Class:
Imidazopyridine hypnotic.
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 ℞ for smallest practical amount. Elderly. Pregnancy (Cat. C). Nursing mothers.
Interactions:
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 Reactions:
Headache, nausea, fatigue; CNS effects, abnormal thinking, complex sleep-related behaviors (eg, sleep-driving), anaphylaxis, angioedema, others (see literature).
How Supplied:
Sublingual tabs—30
