For
people who need a prescription sleep medicine to help them nod off, less is now
more.
 |
| CREDIT: Dreamstime |
The
FDA is requiring that manufacturers of widely used prescription sleep aids
containing the active ingredient zolpidem lower the current recommended dosage
for these medications. The drugs affected are Ambien, Ambien CR, Edluar and
Zolpimist as well as the generic forms of Ambien and Ambien CR. According to
the FDA, new data show that blood levels of zolpidem may be high enough the
morning after people take a sleep medication to interfere with the ability to
perform activities that require them to be alert. Driving-simulation studies
suggest that in some people, zolpidem levels may remain elevated enough to
raise the risk of a motor vehicle accident.
Bringing
down the recommended dosages of the sleep medications will mean blood levels of
zolpidem will be lower in the morning. Because women excrete zolpidem from
their bodies at a slower rate than men, the FDA has directed manufacturers to
lower the recommended dosage for women. The FDA has also informed manufacturers
that labeling should advise doctors to consider prescribing lower dosages to
men.
The
new lower dosage recommendations for women will be 5 milligrams for
immediate-release sleep aids — down from 10 mg — and 6.25 mg for
extended-release products, down from 12.5 mg, according to the FDA. The
labeling should advise doctors to prescribe these same lower dosages — 5 mg for
immediate-release sleep aids and 6.25 for extended-release medications — to
men. Both the higher and lower dosages are currently available.
"To
decrease the potential risk of impairment with all insomnia drugs, healthcare
professionals should prescribe, and patients should take, the lowest dose
capable of treating a patient's insomnia," Dr. Ellis Unger, director of
the FDA's Office of Drug Evaluation, said in a statement. "Patients who
must drive in the morning or perform some other activity requiring full
alertness should talk to their healthcare professional about whether their
sleep medicine is appropriate."
Anyone
who is taking the higher dosage of a sleep aid containing zolpidem should speak
to their doctor before changing the dosage. According to the FDA, impairment
issues aren't unique to sleep aids containing zolpidem. Drowsiness is a common
side effect of any medication used to treat insomnia and people may still
experience drowsiness the day after they take one of these sleep aids.
Alertness can be affected even if a person does not feel tired.
Source: Live Science
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