医師の一分

アクセスカウンタ

zoom RSS 不眠症治療薬マイスリーへの警告/米国医療事情 FDA

<<   作成日時 : 2013/01/15 23:38   >>

なるほど(納得、参考になった、ヘー) ブログ気持玉 1 / トラックバック 0 / コメント 0

不眠症治療薬マイスリーへの警告 FDA
 よく使用されている不眠症治療薬マイスリーを服用すると翌朝の運転や覚醒度の支障となる可能性があるので就寝時の服用量を減らすようにとの勧告をFDAが出した。女性で影響が出やすい。
 FDAによれば、不眠症のすべての薬剤がそうした副作用の可能性があるという。

-----------------------------------------------------
FDA warns on insomnia drugs, suggests lower doses
http://www.reuters.com/article/2013/01/10/us-fda-warning-insomniadrugs-idUSBRE9090WT20130110

Thu Jan 10, 2013 11:43am EST
(Reuters) - The U.S. health regulator warned that taking a widely prescribed insomnia drug at night may impair driving and alertness the next morning, and recommended the bedtime dose be lowered.

New data showed that levels of the drug zolpidem may be high enough to impair alertness in some patients the morning after using it, the U.S. Food and Drug Administration said on its website on Thursday. (link.reuters.com/ten25t)

Women appear to be more susceptible to the risk as they eliminate zolpidem from their bodies slower than men do, the regulator added.

Zolpidem is marketed as a generic under several brand names such as Ambien, Ambien CR, Edluar and Zolpimist.

Ambien is a Sanofi drug that is marketed by SciClone Pharmaceuticals Inc in China. Zolpimist is made by NovaDel Pharma Inc and Edluar belongs to Meda AB.

The regulator has asked manufacturers to lower the recommended doses of the drugs.

Sanofi, NovaDel and Meda could not immediately be reached for comment.

However, the FDA did not recommend any change for another insomnia drug, Transcept Pharmaceuticals' Intermezzo, saying that the drug's label already recommended a lower dosage for women than for men.

The FDA also said that all drugs taken for insomnia can impair driving and other activities that require alertness the morning after use.

(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)

----------------------------------------------------
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)
http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm

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 prescription.
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 answers to provide an additional overview of this safety issue.

テーマ

関連テーマ 一覧


月別リンク

ブログ気持玉

クリックして気持ちを伝えよう!
ログインしてクリックすれば、自分のブログへのリンクが付きます。
→ログインへ
気持玉数 : 1
なるほど(納得、参考になった、ヘー)

トラックバック(0件)

タイトル (本文) ブログ名/日時

トラックバック用URL help


自分のブログにトラックバック記事作成(会員用) help

タイトル
本 文

コメント(0件)

内 容 ニックネーム/日時

コメントする help

ニックネーム
本 文
不眠症治療薬マイスリーへの警告/米国医療事情 FDA 医師の一分/BIGLOBEウェブリブログ
文字サイズ:       閉じる