WASHINGTON -- 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 patients face a higher risk of
injury due to morning drowsiness.
The agency said Thursday that
new research shows that the drugs remain in the bloodstream at levels
high enough to interfere with morning driving, which increases the risk
of car accidents.
Regulators are ordering drug manufacturers to
cut the dose of the medications 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
The FDA is recommending that manufacturers apply these lower doses to men as well, though it is not making them a requirement.
new doses apply to all insomnia treatments containing the drug
zolpidem, which is sold under brands including Ambien, Edluar and
FDA officials say doctors should aim to prescribe the lowest dose possible that will successfully treat insomnia.
who must drive in the morning or perform some other activity requiring
full alertness should talk to their health care professional about
whether their sleep medicine is appropriate," said Dr. Ellis Unger, a
director in FDA's Office of Drug Evaluation.
Unger said in a
statement that the FDA has received a number of reports of car accidents
connected to zolpiderm over the years. However, the agency did not have
enough information to tell how much of a role the drug played in the
The agency decided to take action after recent driving
simulation studies showed that, in some patients, drug levels remained
high enough to cause difficulty driving.
For now, patients should
continue taking their currently prescribed dose until they can talk to
their doctor about the best way to proceed.
Ambien is sold by Sanofi, Edluar by Meda Pharmaceuticals Inc. and Zolpimist by NovaDel Pharma Inc.