FDA forces Lunesta dosage drop over dozing fears

The FDA is making another move to ensure the safety of sleep drugs, and this time the target is Lunesta. The agency has required maker Sunovion to change the drug's label and lower the recommended starting dose after data showed that levels in some patients the morning after could be high enough to impair activities like driving.

Sunovion announced yesterday it will drop the recommended starting dose from 2 mg to 1 mg for both men and women. While healthcare professionals can later increase it to 2 mg or 3 mg depending on need, higher doses are more likely to compromise alertness the next day, the FDA said.

"To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia," Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said in a statement.

The move follows a similar dose reduction the FDA last January put on sleep drugs containing zolpidem, including Sanofi's ($SNY) Ambien. Citing worries of next-day impairment, the agency said it would require companies that make remedies containing the active ingredient to halve the recommended dose for women, who it said eliminate zolpidem from their bodies more slowly than men do.

More than one recent high-profile incident has put sleep drug safety in the spotlight. In March, a jury acquitted Robert F. Kennedy's daughter Kerry after she pinned a highway accident on accidentally taking zolpidem. Her arrest came just a month after U.S. Commerce Secretary John Bryson had two nocturnal car accidents in Los Angeles, and Ambien was later found in his system.

This may not be the end of the FDA's quest to ensure the drugs' safety. The agency is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs--including over-the-counter drugs--and will update the public as new information becomes available, it said.

- read the release
- see Reuters' take

Special Report: 10 big brands keep pumping out big bucks, with a little help from price hikes - Lunesta

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