美國食品藥品管理局(FDA)于1月10日宣布降低某些含有唑吡坦(zolpidem)安眠藥劑量的新要求，這些藥物包括安必恩(Ambien)、安必恩緩釋片、Edluar和ZolpiMist。安必恩和安必恩緩釋片的仿制藥也已上市。這項(xiàng)行動(dòng)是模擬駕駛和實(shí)驗(yàn)室研究最新數(shù)據(jù)公布的結(jié)果，該研究數(shù)據(jù)顯示，服用唑吡坦的部分患者次日早晨仍維持較高血藥水平，足以影響包括駕車在內(nèi)的需要警覺的活動(dòng)。

　　“在分析最新數(shù)據(jù)之后，我們認(rèn)為有必要在這些藥品的標(biāo)簽中添加新的藥物安全信息，包括降低推薦劑量。”FDA藥物評(píng)價(jià)與研究中心藥物評(píng)價(jià)辦公室主任Ellis Unger在1月10日的電話會(huì)議期間說道。“我們希望通過服用較小劑量唑吡坦而降低次日早晨血藥水平。我們強(qiáng)烈要求醫(yī)療專業(yè)人員提醒所有服用這些藥物的患者有關(guān)藥物影響次日早晨需要充分精神警覺活動(dòng)的風(fēng)險(xiǎn)。”

　　對(duì)于女性，F(xiàn)DA目前推薦速釋產(chǎn)品唑吡坦劑量由10 mg降至5 mg，緩釋產(chǎn)品的劑量由12.5 mg 降至6.25 mg(安必恩和安必恩緩釋片的仿制藥也已上市。)“我們最近了解到，女性對(duì)次日早晨影響風(fēng)險(xiǎn)更為敏感，因?yàn)樗齻凅w內(nèi)消除唑吡坦的速率小于男性。”Unger博士指出，這一關(guān)聯(lián)的原因尚不清楚。“校正患者身材大小后，藥物水平并不能解釋男女(在藥物消除方面)的差異。”對(duì)于男性，F(xiàn)DA建議醫(yī)療專業(yè)人員應(yīng)考慮給予同樣較低劑量的唑吡坦(速釋產(chǎn)品5 mg，緩釋產(chǎn)品6.25 mg)。

　　詳細(xì)內(nèi)容參見同時(shí)發(fā)布的《藥物安全通訊》。盡管發(fā)布新建議，但Unger博士強(qiáng)調(diào)，目前正在服用較高劑量上述安眠藥的患者“在與他們的醫(yī)生討論其情況并決定如何安全服藥之前，應(yīng)繼續(xù)按照原來的處方服藥。每位患者的情況不同，應(yīng)與各自的醫(yī)生討論合適劑量。”

　　Unger博士還解釋說，對(duì)次日早晨活動(dòng)的影響不僅限于含有唑吡坦的安眠藥物。“所有安眠藥物均有可能產(chǎn)生這一影響。因此，對(duì)于所有的安眠藥物，醫(yī)療專業(yè)人員均應(yīng)開具能夠預(yù)防失眠的最低劑量。較低劑量將會(huì)減少對(duì)次日早晨活動(dòng)的潛在影響?；颊呷舸稳赵绯勘仨汃{車或完成其他需要充分警覺的活動(dòng)，應(yīng)與其醫(yī)療專業(yè)人員討論他們是否適合服用安眠藥物問題。”

　　他總結(jié)指出，F(xiàn)DA將繼續(xù)評(píng)估其他安眠藥物對(duì)精神警覺損害的風(fēng)險(xiǎn)，包括非處方藥物。

　　更多原文閱讀：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.