FDA requires the manufacturing companies of particular sleeping medications like Ambien and Zolpimist to decrease the recommended dosages by half especially for women. The said agency says that the blood levels of these medications could still be high enough to affect the person’s activities in terms of alertness like driving. Also, FDA recommends the labeling of the medications suggest that doctors consider a lower does for men.
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Females seem to be more vulnerable to the effect for the reason that they remove the drug’s active ingredient, zolpidem from their bodies in a much slower manner compared to men. This is according to FDA experts. This particular action can be applied to zolpidem products that are applied for use in bedtime, those that are marketed as generics and are under the brand names Ambien, Ambien CR, Edluar and Zolpimist. The data they have shown a huge risk of morning conditions prove the highest with the extended release forms of these drugs.
FDA statement notes says, “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.”
These are the specific recommendations:
Zolpidem for women should be decreased from 10 mg to 5 mg. That’s for the immediate-release products like Ambien, Edluar and Zolpimist. On the other hand, for the extended-release products such as Ambien CR, the decrease is from 12.5 mg to 6.25 mg.
Doctors should also give the lowest dose when they prescribe Zolpidem and other insomnia drugs. They should also inform the patients that conditions from sleep drugs can become present even if they are fully awake. However, the recommended doses of Intermezzo which is a lower-dose Zolpidem and is also approved for treatment of middle-of-the-night awakenings are not to change. FDA has also prepared some FAQs to give a certain kind of overview for this safety issue.
You can get more information about this by visiting FDA website. You can also click here for additional information.
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