Updated April 2013
|Important Announcement – January 2013
|The Food and Drug Administration (FDA) has issued an announcement recommending that the bedtime dose of zolpidem be lowered because 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.
The FDA indicates the following:
- 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, the lowest dose that treats the patient’s symptoms should be prescribed.
- Clinicians should 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.
For the full FDA announcement, click here.
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Click here to download PDF version of this document (updated April 2013).
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