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September 27, 2012

While You Were Sleeping

Blockbuster sleep drug Ambien has been hailed as a lifesaver, by women especially, who depend on it to conquer insomnia and jet lag. But its bizarre, sometimes tragic side effects raise alarming questions about the go-to-bedtime fix.

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Lindsey Schweigert was utterly exhausted when she returned home to St. Louis, Missouri, in March 2011 after a weeklong business trip to Washington, D.C. It was her fifth such trip in three months, an unavoidable part of her job with a defense contractor that had her crisscrossing the country selling security software to Pentagon officials. Schweigert, 31, looked forward to turning in early. She made a dinner of pork chops and salad, put on her pajamas, popped an Ambien, and crawled into bed. It was only 6 p.m. or so, but sleep came fast.

After that, her memories are a blur. The next thing she remembers is sitting in the back of a police car, still wearing her pajamas, her hands handcuffed behind her. She had no idea what had happened or how she got there. Though she was sure she hadn't had anything to drink, the officer told her she was under arrest for driving while intoxicated. When they got to the station, Schweigert was booked and thrown into a coed holding cell with a dozen other inmates, mostly male. She quickly claimed a corner, hunched down low, and began to sob. When a fight broke out between two meth addicts, cops intervened with pepper spray. Inmates began vomiting at her feet. Concerned for their safety, officers moved Schweigert and three other female inmates to a separate cell, then released her, finally, at 4:30 a.m.

The first call she made was to her brother, who raced over to pick her up. On the teary ride home, she tried to make sense of the last 10 hours. What on earth just happened to me? The question rang in her head as she replayed the night's events. That's when it hit her: Ambien. Though she'd taken it for years for insomnia, she'd refilled her last prescription on the road and was given the generic formulation, Zolpidem. Maybe the switch explained the surreal turn of events that had landed her in jail.

In the weeks that followed, Schweigert pieced together an account of what had happened to her that night using the police report and witness statements: Sometime after 8 p.m., she got out of bed, rummaged around her house, and drew a bath. With the water still running, she grabbed the keys to her Mini Cooper and scooped up Tyson, her dog, and headed to Steak 'n Shake, a nearby diner. Her roommate came home shortly afterward and was so alarmed by the condition of the house, he thought she had been kidnapped and called the police. Schweigert, meanwhile, never made it to Steak 'n Shake. About a half-mile away, she crashed into a car. Cops on the scene said she was swaying and glassy-eyed. Asked to walk a straight line, she fell three times. Schweigert was charged with driving under the influence and running a stoplight. Though she had no prior DWIs, her license was immediately suspended and her career — and security clearance — was in serious jeopardy.

When Ambien was approved by the Food & Drug Administration in 1992, doctors hailed it as a dramatic improvement over previous sleep aids like Halcion, which had been linked to suicide and psychotic episodes and had been banned in the U.K., Brazil, Argentina, Norway, and Denmark. A big selling point for Ambien, part of a new class of drugs called sedative hypnotics, was that it was less addictive than Halcion and also less likely to leave users feeling groggy or hungover the next day. Approved for short-term treatment of insomnia, Ambien quickly became a go-to drug for travelers — finally, a pill to beat jet lag. Within four years, Ambien became the best-selling sleep aid in the country, at its peak generating $2 billion in sales for French drugmaker Sanofi. In 2007, Zolpidem, a generic version of Ambien, was rolled out and is today one of the country's most-prescribed drugs, with 39 million scrips filled last year alone. Doctors dole it out more frequently than even Percocet and prescription ibuprofen. It's especially popular among women, who suffer from insomnia twice as often as men; older women swear by it to combat menopause-related sleeplessness. All told, women account for 64 percent of Ambien prescriptions.

All medications come with prescribing information detailing a drug's dosage instructions, drug interactions, and adverse reactions. When Ambien was first introduced to the market, its fine print included warnings that sedative hypnotics can cause abnormal thinking, strange behavior, and hallucinations. Sleepwalking was referenced as a rare occurrence, afflicting less than 1 in 1,000 patients. The prescribing information made no mention of hundreds of unsettling reports from users who took Ambien before bed only to later learn that while in a sort of sleep trance, they'd raided their hotel minibars, ordered thousands of dollars' worth of merchandise online, made phone calls, or answered e-mail; that they awoke the next day with no recollection of their conduct, just the evidence in the form of wrappers strewn around their beds, invoices from strange websites, voice mails and texts from perplexed friends.

It wasn't until 2006, when Patrick Kennedy blamed Ambien for his 2 a.m. crash into a Capitol Hill barrier, that the drug and its oddball side effects drew national attention. The disoriented Rhode Island congressman, son of Ted Kennedy, told officers on the scene that he was late for a vote. He ultimately pleaded guilty to driving under the influence of prescription drugs and served a year probation. Around the same time, Sanofi was slammed with a class-action lawsuit by Ambien users who complained of sleep-eating while under the drug's influence. Plaintiffs' lawyer Susan Chana Lask cited examples of clients gobbling buttered cigarettes and raw eggs (including the shells) while in an Ambien-induced haze. "Ambien zombies," she called them.

In the wake of the class action and more than a dozen officially reported incidents of sleep-driving, the FDA agreed to take action. In March 2007, it issued an order mandating stronger warnings for all sedative hypnotics, including Ambien. In addition to revising the labeling, the agency also required the drugmakers to alert doctors about the potential dangers of sleep-driving. The FDA also asked drugmakers to conduct clinical studies to better understand why and how frequently sleep-driving occurs.

But those studies have never been done. According to an excerpt of a sealed document quoted in a recent civil case, Sanofi told the FDA in 2007 that "methodological constraints" precluded them from undertaking the effort. (Sanofi would not comment on the matter.) That's no surprise to Texas attorney Michael Mosher, who in 1992 won a landmark $1.8 million verdict against Halcion's maker, Upjohn Co., claiming that the company suppressed evidence of the drug's dangerous side effects. His suit spawned an FDA investigation that found Upjohn routinely omitted and misrepresented results from clinical studies. "There's little incentive for drugmakers to spend large sums conducting such studies — particularly when the results could be used against them in civil cases," says Mosher.

The result is a medical Catch-22: Although the FDA requires a warning that Ambien may cause sleep-driving, it hasn't compelled any studies or clinical trials to actually verify the link. And since the potential for sleep-driving is already disclosed in the fine print, drugmakers can't be held legally accountable when it occurs.

Instead, researchers have been forced to rely on hundreds of after-the-fact reports from patients and defendants, in addition to small studies conducted intermittently around the world. Two years ago, psychiatrists at Japan's Shimane University found that women are more likely than men to experience adverse reactions from Ambien. (Women retain higher concentrations of Ambien in their blood than men do, likely because they weigh less.) Based on those results, the Japanese doctors recommended that women be given smaller doses than men. Another report published in CNS Drugs, a journal devoted to the treatment of psychiatric and neurological disorders, revealed that common over-the-counter drugs like Benadryl may heighten the effect of Ambien, triggering sleep-related side effects.

Meanwhile, newspapers around the country are reporting Ambien-induced sleep-driving incidents on a near-daily basis. In 2008, while promoting The Bucket List, Jack Nicholson told a photographer, "I took Ambien once. I fell asleep and almost drove off a cliff 50 yards from my house." Three years ago, Steve Martin regaled an audience at the Late Show With David Letterman about how he awoke one morning to learn he'd won $1,000 playing online poker in an Ambien-induced stupor. "I played better out of my mind than I ever had," he joked. "But I never took an Ambien again."

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