The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting that patients face higher risks of injury because of morning drowsiness.
The agency said Thursday that research shows that the drugs remain in the bloodstream at levels high enough to interfere with alertness and coordination, which increases the risk of car accidents.
Regulators are ordering manufacturers to cut the dose in half for women, who process the drug more slowly.
Doses will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.
The FDA is recommending that manufacturers lower the dosage for men as well, though that is not a requirement.
The new doses apply to insomnia treatments containing the widely prescribed drug zolpidem, which is sold under brands including Ambien, Edluar and Zolpimist and in generic forms.
Amtrak losses decline to lowest level since ‘70s
Amtrak’s fiscal 2012 operating loss was the lowest in nearly 38 years, Joseph Boardman, the railroad’s president and CEO, said Thursday.
The $361 million loss for the year ending Sept. 30 was down 19 percent from the previous year.
The last time Amtrak losses were less was 1975.
In a conference call with reporters, Mr. Boardman also laid out an agenda for this year that includes delivery of the first of 70 electric locomotives and 130 long-distance passenger cars, expansion of the Acela Express high-speed service in the Northeast with an additional New York-Washington round trip, and beginning the work necessary to acquire more high-speed trains.
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By Rand Paul
Obama acts as though we no longer have a Constitution
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