Insomnia Drugs: A Wake-Up Call?

By Liz Szabo

Reports about patients who eat, cook and even drive in their sleep after taking Ambien have raised questions about the safety of the insomnia drug and have led some to criticize the nation’s growing use of prescription sleep aids.

Ambien’s maker defends the safety of the drug, noting that such bizarre side effects are extremely rare. Yet experts don’t know exactly how often they occur, or which patients may be most susceptible. And with doctors writing 26 million prescriptions for Ambien a year, even rare events could affect a lot of patients, says Michel Cramer-Bornemann, a doctor at the Minnesota Regional Sleep Disorders Center in Minneapolis.

Recent research paints a picture of disturbing behavior.

*Ambien is one of the top 20 drugs found in the blood of drivers pulled over by Wisconsin police, says Laura Liddicoat, a supervisor of the forensic toxicology program at the Wisconsin State Laboratory of Hygiene, who presented her findings at a February meeting of the American Academy of Forensic Scientists. Ambien showed up in 187 drivers arrested by Wisconsin police from 1999 to 2004, according to a separate analysis by the state lab.

*Ambien was linked to 99 traffic accidents reported to the Food and Drug Administration between 1998 and 2005, according to an analysis performed this month by Charles Bennett, a professor at Northwestern University’s Feinberg School of Medicine. Bennett notes that the total number of Ambien-related car accidents could be much higher, because, on average, only about 1% of drug problems are ever reported.

*Nineteen patients were eating in their sleep after taking Ambien, according to a June 2005 article in the journal Sleep. One found a near-empty tub of margarine on her kitchen counter, with no idea who had devoured it overnight. Two started small fires while trying to cook.

“We’re significantly concerned because this is a problematic behavior and we actually are seeing it a lot more than we would have anticipated,” says Cramer-Bornemann, the article’s co-author.

More than 50 million Americans have chronic sleep disorders, according to an April report by the Institutes of Medicine, which advises Congress on health policy. Americans spent nearly $2.8 billion on sleeping medications last year, according to IMS Health, which tracks drug sales.

Is Ambien entirely to blame?

Kimberley Thacker, vice president of medical affairs at Sanofi-Aventis, says her company recently conducted a safety review of Ambien and found “no significant change” in its safety. She adds that the drug is very safe when used properly.

Thacker notes that Ambien’s label already lists sleepwalking as a “possible rare adverse event,” defined as one that affects fewer than 1 in 1,000 patients. About 4% of people walk in their sleep, she says, so Ambien may not have caused these episodes.

Some cases of Ambien-related sleep driving may not have been accidental, Liddicoat says, noting that many of the drivers in her report had sky-high levels of Ambien in their blood, suggesting these people were abusing the drug.

Cramer-Bornemann says his research suggests that some patients may be at higher risk. In his study, almost 90% of sleep eaters were also taking antidepressants. Other risk factors could include sleep apnea, restless leg syndrome and a history of sleepwalking. He says it’s important for doctors to talk about Ambien’s risks before prescribing it.

More research needed

The National Institutes of Health also has called for more research into insomnia and its treatments. Many drugs taken for insomnia have never been tested for long-term use — even though patients often take them for years. Some commonly used treatments for sleeplessness — antidepressants and antihistamines — aren’t approved for insomnia, the report says.

To some doctors, the potential side effects aren’t worth the risks. In many trials, patients who take pills fall asleep a “trivial” 15 to 20 minutes faster than those who don’t use drugs, says Sidney Wolfe, director of the Health Research Group for Public Citizen, a Washington-based consumer advocacy group.

Other sleep experts say patients don’t necessarily need to abandon the drug. People shouldn’t deprive themselves of helpful therapies because of small risk, says Edward Stepanski of Memphis, who specializes in sleep issues for cancer patients. Women suffering from hot flashes or patients with chronic pain, he says, may find it difficult to rest without medication.

“I just hate the idea that people who would really benefit from the medication don’t take it because they are afraid,” Stepanski says.

(c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.