(Adds background and details from FDA conference call)
Jan 10 U.S. health regulators recommended that
the bedtime dose of widely prescribed insomnia drugs Ambien,
Edluar and Zolpimist be lowered, as they could impair alertness
and driving ability in some people the next morning.
New data showed the risk for next-morning impairment is
highest for patients taking extended-release forms of the pills,
which contain the drug zolpidem. (link.reuters.com/ten25t)
Women appear to be more susceptible to the risk as they
eliminate zolpidem from their bodies slower than men do, the
Ambien is a Sanofi drug, while Zolpimist, an oral
spray, is made by NovaDel Pharma Inc. Edluar is
manufactured by Swedish drugmaker Meda AB.
The U.S. Food and Drug Administration asked manufacturers of
Ambien, Edluar and Zolpimist to recommend a dose of 5 mg once
daily for women from the current 10 mg.
For Ambien CR, an extended-release form of the drug, the
agency proposed a dose of 6.25 mg once daily for women, down
from 12.5 mg.
Men can be prescribed either the new recommended doses or
the older ones, the regulator said, but asked for labeling that
health professionals consider prescribing the lower dose.
Sanofi, NovaDel and Meda could not immediately be reached
However, the FDA did not recommend any change for a similar
low-dose zolpidem product - Transcept Pharmaceuticals'
Intermezzo - as the drug's label already recommends a lower
dosage for women than for men.
The FDA said on a conference call with reporters that it
would ask for driving studies for all similar drugs seeking
Merck's suvorexant is currently being reviewed by
the FDA for treatment of insomnia.
The FDA also said that all drugs taken for insomnia can
impair driving and other activities that require alertness the
morning after use.
In 2011, about 39 million prescriptions for zolpidem drugs
were dispensed and about 9 million patients received zolpidem
products from U.S. outpatient retail pharmacies, 63 percent of
who were female, the FDA said.
The regulator is continuing to evaluate the risk of impaired
mental alertness with other insomnia drugs, including
over-the-counter drugs that are available without a
(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)