FDA Slashes Bedtime Dose For Ambien, Other Sleep Drugs
A slew of sleeping pills including the popular Ambien had their bedtime doses slashed by the U.S. Food and Drug Administration (FDA) because new data indicates that some patients who use these drugs may suffer from impaired alertness the next morning.
The FDA safety alert focuses on products containing zolpidem that are approved for bedtime use including brand names such as Ambien, Ambien CR, Edluar, and Zolpimist as well as their generic versions. Data shows that the risk of alertness impairment the next morning is the highest in patients who take the extended release form of these drugs like Ambien CR and generics.
The FDA also warned that women are more susceptible to the risks associated with zolpidem as they eliminate it from their bodies slower than men.
The agency has asked the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose of these insomnia drugs for women; the labeling should also recommend that health care professionals consider a lower dose for men. Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours.
The FDA will continue evaluating the risks of impaired mental alertness with other insomnia drugs, including over-the-counter drugs that are available without prescriptions.
Drowsiness and impairment of mental alertness in the morning after use are common side effects of all insomnia drugs.
If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law today for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you.