Today the FDA issued a new safety announcement and consumer update about some common sleeping pills used to treat insomnia. The FDA is requiring drug makers to lower the recommended doses for products that contain the drug zolpidem.
The FDA is concerned that the current dose recommendations may be too high. As a result, some people may still be drowsy the morning after taking a sleeping pill. This can be a health and safety risk, especially while driving.
This risk of drowsiness may be higher among women. The risk also may be greater for people who take the extended-release form of zolpidem.
The new dose limits apply to the following medications: Ambien, Edluar and Zolpimist:
• Dose lowered from 10 mg to 5 mg for women.
• Doctors also should consider prescribing the lower dose of 5 mg for men.
Ambien CR (extended-release):
• Dose lowered from 12.5 mg to 6.25 mg for women.
• Doctors also should consider prescribing the lower dose of 6.25 mg for men.
• No changes. Labeling already recommends a lower dose for women than men.
Like any other drug, sleep medications may cause some side effects. A few years ago the FDA asked drug makers to add stronger