FDA要求降低另一种安眠药艾司佐匹克隆的起始剂量

美国食品药品管理局（FDA）5月15日宣布，安眠药物艾司佐匹克隆推荐起始剂量已由2 mg降至1 mg，以减少与药物有关的次日早晨损害风险。

FDA声明指出，要求艾司佐匹克隆（商品名：Lunesta）生产商改变推荐起始剂量，因为有证据表明，“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完全警觉的活动。该推荐剂量适用于男性和女性。”

声明还称，如有必要，1 mg剂量可增加至2 mg或3 mg，“不过，较高剂量更有可能影响次日早晨包括驾车在内的需要完全警觉的活动。”FDA还建议，目前正在服用2 mg或3 mg剂量的患者应就他们如何继续安全用药问题与医生沟通，并警告服用3 mg剂量的患者次日不要驾车或从事其他需要完全警觉的活动。

FDA称，上述建议部分基于一项纳入91例24~40岁健康成人的研究结果，该研究比较了3 mg剂量艾司佐匹克隆与安慰剂的作用。男性和女性受试者服用3 mg剂量艾司佐匹克隆与次日早晨（服药后7.5小时）严重精神运动和记忆损害相关。按照原来推荐剂量，服药后11个小时对驾驶技能、记忆力和协调性的损害仍然明显，并且尽管存在这些持久影响，但患者通常没有意识到他们所受的损害。

2013年1月，FDA曾建议降低含有唑吡坦的安眠药物的剂量，包括安必恩（Ambien）和安必恩缓释片（Ambien CR）。

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The recommended starting dose for the insomnia drug eszopiclone has been lowered from 2 mg to 1 mg, to address the risk of next-morning impairment associated with the drug, the Food and Drug Administration announced on May 15.

The manufacturer of the drug, marketed as Lunesta, was required to change the starting dose recommendation because of evidence that levels of the drug "in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake," the FDA statementsaid. The recommendation applies to men and women.

If necessary, the 1-mg dose can be increased to 2 mg or 3 mg, "but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness," the statement added. The FDA also is advising patients who are on the 2-mg or 3-mg doses to contact their health care providers for advice on how they can continue the drug safely, and is cautioning patients on the 3-mg dose not to drive or engage in other activities "that require complete mental alertness the day after use."

The recommendations are based partly on the results of a study of 91 healthy adults aged 24-40 years, which compared the effects of the 3-mg dose of eszopiclone and placebo, according to the FDA. The use of the 3-mg dose was associated with severe psychomotor and memory impairments in men and women the next morning, 7.5 hours after taking the medication. At recommended doses, impairments in driving skills, memory, and coordination were evident for up to 11 hours after the drug was taken, and "despite these long-lasting effects, patients were often unaware they were impaired," the statement said.

In January 2013, the FDA recommended reducing the dose for sleep medications containing zolpidem, which include Ambien and Ambien (CR), for the same reason.

The safety communication regarding this drug is available here. Serious adverse events associated with this and other insomnia drugs should be reported to the FDA at 800-332-1088 or at the MedWatch website.