Ambien—trade name Zolpidem in the United States—has been linked to six deaths in the United Kingdom and a large number of adverse reactions. Ambien is the sleeping drug which actor Heath Ledger admitted taking just weeks prior to his death. Ledger was found dead by his housekeeper at his New York apartment last Tuesday, and Ambien was among the prescriptions drugs found in his apartment. Results of a postmortem examination last week on the actor were inconclusive and additional toxicology testing is being conducted; however, there has been growing speculation that Ledger died from an accidental overdose of sleeping pills.
In Britain, were it is marketed as Stilnoct, Ambien is suspected in six fatal suspected adverse drug reactions since 2002, according to the Medicines and Healthcare products Regulatory Agency (MHRA) since 2001. In addition to the deaths, there have been nearly 200 other incidents of adverse reactions, ranging from psychiatric and cardiac disorders to injuries and eye disorders reported to the MHRA since 2001.
Ledger’s death prompted actor Jack Nicholson to say that the tragedy could be a warning about the dangers of certain sleeping pills. Nicholson reported that he had taken Ambien and suffered serious side effects as a result, saying “I warn people about Ambien. I almost drove off a cliff once. I don’t take sleeping pills but somebody said, ‘take this, it’s mild’.” “I got a call in the middle of the night, kind of an emergency, and I almost drove off a cliff 50 yards from my house. I live up in the mountains in Aspen. It’s something to warn people about,” he said.
MHRA data indicate the incidents are recorded under its “yellow card” scheme, which doctors in the UK use to alert the MHRA to patients suffering side effects to a drug. Health professionals and patients report reactions on a voluntary basis while companies are legally bound to report. The reporting system was created to act as an early warning system to alert authorities to previously unrecognized problems.
In addition to the fatalities, a total of 197 suspected adverse drug reactions have been reported connection with Ambien. The majority of the cases were categorized as psychiatric disorders. The six cases of deaths linked to a suspected adverse reactions to the drug were also recorded and three of those involved psychiatric disorders; the remainder were categorized as general disorders, injuries, and vascular disorders.
Last year, research by Australia’s Federal Health Department linked Zolpidem to a series of incidents of strange behavior, including a woman who painted her front door while still asleep. And problems have emerged in America, where some people were injured by cars driven by people under the influence of the drug.
A spokesman for the MHRA said the safety of Zolpidem has been carefully monitored and product information had been updated to include warnings of psychiatric adverse effects. A spokesman for Sanofi Aventis, which makes Stilnoct, said it could not comment on the MHRA figures, but said when taken as prescribed, the drug was “generally well tolerated.”
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