Sleep drugs have been the root of plenty of safety worries over the years, especially when it comes to driving while under their influence. Now, just a week after the wrap of one of the highest-profile cases to revolve around Ambien generic zolpidem--Kerry Kennedy's--the European Medicines Agency' (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending updates to its product information to underscore the drug's associated risks.
According to PRAC, the proposed changes are aimed at further minimizing the well-documented risks of next-morning impaired driving ability and mental alertness; they come following a review of the drug prompted by reports of morning-after road accidents, the committee said in a release. PRAC recommends the product information include strengthened warnings and precautions, and that patients refrain from driving until 8 hours after taking the drug. It did not, however, push for a lower recommended daily dose.
The EMA is not the only regulatory body to reassess the guidelines for sleep aids as of late. This January, the FDA said it would require drugmakers that sell sleep remedies that contain zolpidem--including Ambien-maker Sanofi ($SNY)--to halve the recommended dose for women, who the agency said eliminate zolpidem from their bodies more slowly than men do.
A recent trial has also put zolpidem's safety risks in the spotlight, with the daughter of Robert F. Kennedy pinning a highway accident on the med. As The Guardian notes, Kennedy's lawyers argued the 54-year-old took zolpidem in a mix-up, mistaking it for her daily thyroid medication before side-swiping a truck in a drive she said she didn't remember. Prosecutors agreed the events were an accident, not a crime, and a jury acquitted her of drugged-driving charges that could have landed her up to a year in jail.
"If I realized I was impaired, I would have pulled over," Kennedy testified.
It's not the first time the public has had its eye on a sleep-drug case. Kennedy's arrest came just one month after U.S. Commerce Secretary John Bryson had two nocturnal car accidents in Los Angeles; Ambien was later found in his system.
- read the release
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