Sleep Aid Medication Not Safe Enough Says FDA
Regulators at the US Food and Drug Administration have denied for a second time a sleep aid drug over safety concerns. Trancept Pharmaceuticals formulation of zolpidem tartrate (a similar formulation used in Ambien) has been trying to get approval for a sublingual tablet they hope to market at Intermezzo. This sleep aid would be marketed towards those who wake in the middle of the night and can't get back to sleep. The problem is regulators have doubts over safety. Taking a dose of this drug with less than 4 hours of sleep time may result in severe morning drowsiness. The stories of sleep driving, sleep walking and sleep falls have all been documented and are receiving attention. Driving While Drowsy is Unsafe According to the Centers for Disease Control and Prevention, drowsy driving contributes to an estimated 100,000 motor vehicle crashes and about 1,500 deaths each year. In fact, in 2007, FDA regulators requested that all manufacturers of sedative-hypnotic drugs include stronge...