美国食品药品管理局(FDA)于1月10日宣布降低某些含有唑吡坦(zolpidem)安眠药剂量的新要求，这些药物包括安必恩(Ambien)、安必恩缓释片、Edluar和ZolpiMist。安必恩和安必恩缓释片的仿制药也已上市。这项行动是模拟驾驶和实验室研究最新数据公布的结果，该研究数据显示，服用唑吡坦的部分患者次日早晨仍维持较高血药水平，足以影响包括驾车在内的需要警觉的活动。

　　“在分析最新数据之后，我们认为有必要在这些药品的标签中添加新的药物安全信息，包括降低推荐剂量。”FDA药物评价与研究中心药物评价办公室主任Ellis Unger在1月10日的电话会议期间说道。“我们希望通过服用较小剂量唑吡坦而降低次日早晨血药水平。我们强烈要求医疗专业人员提醒所有服用这些药物的患者有关药物影响次日早晨需要充分精神警觉活动的风险。”

　　对于女性，FDA目前推荐速释产品唑吡坦剂量由10 mg降至5 mg，缓释产品的剂量由12.5 mg 降至6.25 mg(安必恩和安必恩缓释片的仿制药也已上市。)“我们最近了解到，女性对次日早晨影响风险更为敏感，因为她们体内消除唑吡坦的速率小于男性。”Unger博士指出，这一关联的原因尚不清楚。“校正患者身材大小后，药物水平并不能解释男女(在药物消除方面)的差异。”对于男性，FDA建议医疗专业人员应考虑给予同样较低剂量的唑吡坦(速释产品5 mg，缓释产品6.25 mg)。

　　详细内容参见同时发布的《药物安全通讯》。尽管发布新建议，但Unger博士强调，目前正在服用较高剂量上述安眠药的患者“在与他们的医生讨论其情况并决定如何安全服药之前，应继续按照原来的处方服药。每位患者的情况不同，应与各自的医生讨论合适剂量。”

　　Unger博士还解释说，对次日早晨活动的影响不仅限于含有唑吡坦的安眠药物。“所有安眠药物均有可能产生这一影响。因此，对于所有的安眠药物，医疗专业人员均应开具能够预防失眠的最低剂量。较低剂量将会减少对次日早晨活动的潜在影响。患者若次日早晨必须驾车或完成其他需要充分警觉的活动，应与其医疗专业人员讨论他们是否适合服用安眠药物问题。”

　　他总结指出，FDA将继续评估其他安眠药物对精神警觉损害的风险，包括非处方药物。

　　更多原文阅读：FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist).FDA.2013 Jan 10.

　　Safety Announcement

　　[1-10-2013] The U.S. Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Today’s announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

　　FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.

　　FDA urges health care professionals to caution all patients (men and women) who use these zolpidem products about the risks of next-morning impairment for activities that require complete mental alertness, including driving. For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men (see Data Summary).

　　Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose. FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-release products and 6.25 mg for extended-release products (see Dosing Recommendations).

　　The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for  men.

　　FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a presc**tion.

　　To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia. Patients who drive or whose activities require full alertness the morning after use of an insomnia drug should discuss the appropriateness of their medicine with their health care professional (see Insomnia Medicines).

　　FDA has prepared a list of questions and answers2 to provide an additional overview of this safety issue.