Changing US sleep patterns
January 11, 2013
THE manufacturers of Ambien,
Ambien CR, Edluar and Zolpimist,
widely used sleep drugs that contain
the active ingredient zolpidem, are
being forced to lower the current
recommended doses in the US.
The move by the US Food and
Drug Administration will see
changes in both branded and
generic sleep aids containing
zolpidem, with the agency
informing manufacturers that the
recommended dosage of zolpidem
for women should be lowered from
10 milligrams (mg) to 5 mg for
immediate-release products
(Ambien, Edluar, and Zolpimist) and
from 12.5 mg to 6.25 mg for extendedrelease
products (Ambien CR).
For men, the FDA has informed
the manufacturers that the labeling
should recommend that health care
professionals consider prescribing
these lower doses (5 mg for
immediate-release products and
6.25 mg for extended-release
products).
“These products are currently
available on the market in both the
higher and lower dosages.
The change in dosage
recommendations follows the
release of new data which shows
that zolpidem blood levels in some
patients may be high enough the
morning after use to impair
activities that require alertness,
including driving.
Using lower doses of zolpidem
means less of the drug will remain
in the blood in the morning hours.
“Since women eliminate zolpidem
from their bodies more slowly than
men, the FDA has notified the
manufacturers that the
recommended dose should be
lowered for women and that the
labeling should recommend that
health care professionals consider a
lower dose for men,” the FDA said.
“Data show the risk for nextmorning
impairment is highest for
patients taking the extendedrelease
forms of these drugs.
“The FDA urges health care
professionals to caution all patients
(men and women) who use these
products about the risks of nextmorning
impairment for activities
that require complete mental
alertness, including driving,” the
FDA added.
Meanwhile, for those already
taking higher doses (10 mg or 12.5
mg) of zolpidem-containing
insomnia medicines, the FDA has
advised them to keep with their
prescribed dose, until they discuss
how they can safely continue to
take their medicine with their GP.
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