November 24, 2011
New Drug Stops People From Waking Up In Middle Of Night
On Wednesday, the U.S. Food and Drug Administration (FDA) approved medication specifically designed for those who wake up in the middle of the night and can't fall back to sleep.
Transcept Pharmaceuticals Intermezzo is a lower-dose formulation of Zolpidem, which was first approved in the U.S. in 1992 and is better known as Ambien.
"This is the first time the FDA has approved a drug for this condition," theFDA said in a statement.
"Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid."
Transcept Pharmaceuticals recommends a 3.5 milligram dose for men and half of that for women. Clinical tests indicated that women cleared zolpidem from their bodies slower than men.
"With this lower dose, there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving," Robert Temple of the FDA's Center for Drug Evaluation and Research said in a statement.
The company changed the Intermezzo label to say that the drug should only be taken when people have at least four hours of sleep time remaining. The label also advises people not to drive for at least one hour after waking up and at least five hours after taking the drug.
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