FDA Issues New Guidelines for Sleep Aids Containing Zolpidem

FDA has issued new dosing recommendations for sleep aids containing zolpidem. The new recommendations are based upon new data that shows that when taken at night, blood levels of zolpidem remain high enough in the morning to impair activities that require alertness, such as driving. The new guidelines halve the dosage for women because the new data showed that their bodies take longer to eliminate the drug. FDA urges drug manufacturers and health care providers to follow the new dosing instructions, which apply to brand name and generic drugs containing zolpidem: •Ambien® •Edluar™ and Zolpimist®; 5 mg for women, 5 mg or 10 mg for men •Ambien CR®: 6.25 mg for women, 6.25 mg or 12.5 mg for men Additionally, manufacturers of these drugs have been instructed to follow the new guidelines and print new patient information drug labels containing the new recommendations. 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.
http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm?utm_source=BenchmarkEmail&utm_...