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Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses. Including Ambien, Ambian CR, Edluar, and Zolpimist
AUDIENCE: Family Practice, Health Professional, Patient
ISSUE: 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. This 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.
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.
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 is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.
FDA prepared a list of questions and answers to provide an additional overview of this safety issue. See the FDA Drug Safety Communication for a Data Summary.
BACKGROUND: Zolpidem is a sedative-hypnotic (sleep) medicine used in adults for the treatment of insomnia. It is marketed as generics and under the brand-names Ambien, Ambien CR, Edluar, Zolpimist, and Intermezzo.
RECOMMENDATION: FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.
* 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).
* For zolpidem and other insomnia drugs, prescribe the lowest dose that treats the patient's symptoms.
* Inform patients that impairment from sleep drugs can be present despite feeling fully awake.
* 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MeDWatch alert, including links to the Drug Safety Communication, News Release, and Q&As, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA告知大眾，zolpidem，一種普遍使用的安眠藥之最新警訊。最新的資料顯示，部分病人服用後次日早晨的血中濃度較 高，以致於無法從事需集中注意力的工作如開車…等，FDA建議睡前劑量應降低。此公告針對於核准在睡前使用之zolpidem，商品名如Ambien、 Ambien CR、Edluar，和Zolpimist。
FDA也提醒大眾所有的安眠藥於服藥後皆可能影響次日開車和需高度專注之活動。嗜睡為所有安眠藥仿單中標示之常見副作用，病人於服藥後可能會一整天昏昏欲睡，即使完全清醒也可能感到精神不濟。
資料顯示，服用持續釋放劑型之藥品其出現次日早晨精神不濟的情況最多。女性因自體內排除zolpidem速度較男性慢，更容易產生此風險。
因使用低劑量之zolpidem將導致隔日早晨較低的血中濃度。FDA要求廠商降低建議劑量，也正持續評估其他可能影響精神警覺性之安眠藥，包含非處方藥。
Zolpidem為用於治療失眠之鎮靜安眠藥，其於美國上市之藥品商品名有Ambien，Ambien CR，Edluar，Zolpimist，和Intermezzo。
FDA呼籲醫療專業人員注意所有服用此類藥品且須從事集中注意力活動包含開車等之病人（無論男性或女性）其產生隔日精神不濟之風險。
FDA之建議如下：
1. 針對女性，含zolpidem成分之速效錠其建議劑量應由10 毫克降低為5毫克，緩釋錠應由12.5毫克降為6.25毫克。
2. 對於需使用zolpidem和其他安眠藥之病人，使用最低能治療其症狀之劑量。
3. 告知病人服藥後儘管感到清醒，也可能出現精神不濟之症狀。
4. 被核准用來改善半夜醒來之低劑量zolpidem（商品名：Intermezzo）其建議使用劑量不變。Intermezzo於2011年11月核准之仿單中已建議女性需使用較男性低的劑量。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 01/10/2013]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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資料來源：藥師週刊（第1812期）