Manufacturers of Popular Sleeping Pills Need to Lower Dosage: FDA

The manufacturers of popular sleeping pills, such as Ambien, are being asked by the US Food and Drug Administration to lower the dosage in each pill after recent studies revealed that people who take the pills are at a high risk of injuries due to morning drowsiness. The FDA revealed that recent studies have shown that the levels of the drugs present in the bloodstream early in the morning are high enough to cause accidents, including car accidents. The agency went on to say that the findings are true for all sleeping pills and said that all of the pills carry warnings of drowsiness.

The FDA added that it will be asking the manufacturers to lower the dosage from 5 to 10 milligrams to regular pills and 6.25 to 12.5 milligrams for extended-release formulations.

Dr Ellis Unger, a director in FDA’s Office of Drug Evaluation, said that sleeping pill manufacturers will also be asked to conduct driving trials to check whether their drugs interfere with co-ordination of the user early in the morning. “A lot of people are wondering about the elephant in the room. Why did this take so long? This is science, and our thinking evolves over time”, he said.



Source-Medindia