By Kim Dixon
Posted Saturday, May 06, 2006

Reuters

CHICAGO — Rep. Patrick Kennedy’s statement that he used Sanofi-Aventis’ sleep drug Ambien to explain how he was involved in a late-night car crash has revived questions over whether the drug causes side effects like sleepwalking and binge eating.

The Rhode Island Democrat also had taken the prescription anti-nausea drug phenergan before crashing his car into a security barrier in Washington early Thursday morning. No one was hurt in the incident, but Kennedy said Friday he was checking himself into a program for further treatment of a chronic addiction to prescription pain pills.

“I simply do not remember getting out of bed, being pulled over by police or being cited for three driving infractions,” Kennedy told a news conference. “I am deeply concerned about my reaction to the medication and my lack of knowledge of the accident that evening.”

On Thursday, Kennedy said that after a series of votes Wednesday night he took the prescribed amount of phenergan, which treats gastroenteritis, as well as Ambien. He said he had not consumed alcohol.

Sanofi-Aventis says Ambien, used by millions of people since its introduction in 1993, has lulled patients to sleep for 12 billion nights in the U.S. It says sleepwalking is a rare side effect and it stands by the drug’s safety.

But researchers at Hennepin County Medical Center in Minnesota have identified more than two dozen cases of dangerous sleepwalking among people who took Ambien, and they believe the phenomenon is more common than the company says.

“We are seeing pretty extreme expressions of sleepwalking — like getting into a car and driving,” said Michel Cramer-Bornemann, a researcher at the clinic. “And when we remove the Ambien, it is resolved.”

The data, to be submitted for publication in several months, is still anecdotal. “But good science starts with observation,” he said.

Michael Sateia, chief of sleep medicine at Dartmouth Medical School, said, “There is white-hot attention on this particular agent, but we need to be cautious about jumping to conclusions.”

The high-profile cases are leading some lawyers to seize the opportunity.

“I call them Ambien zombies,” said Susan Chana Lask, an attorney who filed a suit in U.S. District Court in Manhattan in March for clients who charge Ambien caused them to do things like “sleep eat” and “sleep drive.”

“We are going to start using this as a defense for people who were using it when they get arrested while driving under the influence. The cops can’t figure it out because the person is really loopy and disoriented,” Lask said.

About 30 million people in the United States take sleep medications, according to the American Academy of Sleep Medicine and Ambien leads the market by far. By some counts, that is a 50-percent jump in the use of such drugs since the beginning of the decade.

Serious suspected side effects are short-term memory loss and cases of patients involved in road accidents a day after taking the drug who complained they still felt drugged.

Sanofi has said about 4 percent of people might sleepwalk with or without the drug.

That estimate is a bit high, according to Donna Arand, president of the American Insomnia Association.

She explained that sleepwalking occurs when a patient’s brain goes into the deepest cycles of sleep and has trouble getting back into the lighter cycles. “You end up with a sleeping brain and an awake body,” she said.

Sateia of Dartmouth suggested that Sanofi should re-examine the original trial data it submitted to regulators when it won approval.

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