June 22, 2018
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FDA recommends lower dose of insomnia drugs Ambien, Edluar, Zolpimist

By Staff, Reuters

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.

Women appear to be more susceptible to the risk as they eliminate zolpidem from their bodies slower than men do, the regulator added.

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 milligrams once daily for women from the current 10 milligrams.

For Ambien CR, an extended-release form of the drug, the agency proposed a dose of 6.25 milligrams once daily for women, down from 12.5 milligrams.

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 for comment.

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 approval.

Merck’s suvorexant is 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 prescription.


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