From 3/14/2006 NY Times Study Links Ambien Use to Unconscious Food Forays By STEPHANIE SAUL The sleeping pill Ambien seems to unlock a primitive desire to eat in some patients, according to emerging medical case studies that describe how the drug's users sometimes sleepwalk into their kitchens, claw through their refrigerators like animals and consume calories ranging into the thousands. The next morning, the night eaters remember nothing about their foraging. But they wake up to find telltale clues: mouthfuls of peanut butter, Tostitos in their beds, kitchen counters overflowing with flour, missing food, and even lighted ovens and stoves. Some are so embarrassed, they delay telling anyone, even as they gain weight. "These people are hell-bent to eat," said Dr. Mark Mahowald, who is director of the Minnesota Regional Sleep Disorders Center in Minneapolis and is researching the problem. He and colleagues are preparing a scientific paper based on their findings that a sleep-related eating disorder is one of the unusual side effects showing up with the widespread use of Ambien. Researchers at the Mayo Clinic in Rochester, Minn., have made similar findings. A woman in Salinas, Calif., whose case is to be included in the Minnesota study, said she would awaken to find candy bar wrappers next to her bed and Popsicle sticks on the floor near the refrigerator. She blamed her husband and sons before finally believing their claims that she was eating at night, unaware. Worried that she would choke, "my son was so afraid at night, he'd come sit by the bed and watch me," said the woman, Brenda Pobre, 54. Despite seeing several doctors, Ms. Pobre did not link Ambien to her nocturnal eating until after she gained 100 pounds. Spurred in part by consumer advertising, more than 26 million prescriptions for Ambien were dispensed in this country last year, an increase of 53 percent since 2001. Sanofi-Aventis, the French company that makes the drug, has defended its safety in 13 years of use in the United States. A company spokeswoman, Melissa Feltmann, said, "Sanofi-Aventis has received reports of people eating while sleepwalking and those reports, like all reports of adverse events, have been provided to the U.S. Food and Drug Administration." Ms. Feltmann said that the package insert for Ambien warns that a sleep-related eating disorder may occur, but she cautioned that every case reported in patients taking Ambien might not necessarily be caused by the drug. Most of the people who use Ambien say the drug puts them to sleep, and they wake up without incident. But several doctors and a number of patients say that sleep-eating is one of a variety of unusual reactions to the drug. The reactions range from fairly benign sleepwalking episodes to hallucinations, violent outbursts and, most troubling of all, driving while asleep, a subject explored in an article last week in The New York Times. The Food and Drug Administration has said in response to a Times reporter's query that it would monitor the drug's safety record. Dr. Carlos H. Schenck, a sleep disorders expert in Minneapolis and the lead researcher on the study, estimates that thousands of Ambien users in the United States experience sleep-related eating disorders while taking the drug. Ambien, the brand name used in the United States for the drug zolpidem, is sold in some countries under the brand names Stilnox and Stilnocht. In this country it is by far the biggest seller among a group of similar prescription sleeping drugs that include Lunesta and Sonata. The drug's growth into a product worth $2.2 billion in annual sales in the United States has been fueled partly by consumer advertising. Sanofi-Aventis spent $130 million to advertise the product in 2005, more than double the $61 million it spent in 2004, according to figures released by TNS Media Intelligence. No cause has been found for sleep-related eating disorder, but Dr. Schenck says he believed that it happened when the brain confuses two basic instincts: sleeping and eating. "Those two become linked," he said. "In the sleep stage you eat. I think two instinctual behaviors become intertwined." Along with Dr. Mahowald and other colleagues at the University of Minnesota Medical School and the Hennepin County Medical Center in Minneapolis, Dr. Schenck has identified 32 Ambien users having sleep-related eating disorder with amnesia, part of a group of case studies they are planning to publish. Often patients with sleep-related eating disorder caused by Ambien realize they have an eating problem, but do not associate it with the sleeping pill until they find a doctor who is aware of the relationship, Dr. Schenck said. The problem can occur spontaneously without drugs, and there have also been scattered reports linking the disorder to other medications, including Halcion. This leads some experts to question whether sleep-eating associated with Ambien is less a function of the drug itself and more a characteristic of some of the large number of people now taking it. "I think abnormal behaviors like those could be unmasked in a small minority of patients taking any medications in that class, and the most common administered medication at bedtime is Ambien at this time," said Dr. John W. Winkelman, medical director of the Sleep Health Center at Brigham and Women's Hospital in Boston. But Dr. Schenck said the cluster of Ambien sleep-eaters that his team discovered makes the drug the one most commonly associated with sleep-related eating disorder. He added that many of his patients' eating problems ended when they switched to other sleep medications, including Lunesta and Sonata. Sleep experts at the Mayo Clinic have come to a similar conclusion — that there is something in Ambien that causes sleep-eating in susceptible people. "In our mind, certainly in our clinical experience, zolpidem is associated with this," said Dr. Michael H. Silber, co-director of the Sleep Disorders Center at the Mayo Clinic. Dr. Silber is also president-elect of the American Academy of Sleep Medicine. Dr. Silber and a colleague were the first to describe sleep-related eating disorder with amnesia in Ambien users in 2002 in the journal Sleep Medicine. The five cases discussed in that paper involved patients with a condition called restless legs syndrome. Since then, Dr. Silber said he had seen other Ambien users with sleep-related eating disorder. "This is really an upsetting thing for them to see what they're doing during the night," he said. "They put on weight. I could imagine setting fire to things" while preparing food. Among sleep-eaters, the desire for food can be tremendously powerful. One woman in the Minneapolis area whom Dr. Schenck treated, Judie Evans, said she began taking Ambien while recovering from back surgery. At the time, she was in a full body cast and needed assistance to get out of bed. During this time, Ms. Evans, who is 59 and lives alone, began to notice that food was missing from her refrigerator. She accused two nursing aides who were caring for her of stealing food. It was not until her son came to spend several nights that Ms. Evans said she realized that despite the body cast, she was getting up to eat while she was asleep. "During the day, I couldn't even make it to the bathroom by myself," Ms. Evans said. The first night her son was there, he found her standing in the kitchen, body cast and all, frying bacon and eggs. The next night he found her eating a sandwich, Ms. Evans said, and sent her back to bed. Later that same night, her son arose to find her standing in the kitchen again. "I had turned the oven on," she recalled. "I store pots and pans in the oven and I had turned it to 500 degrees." Ms. Evans said her problems ended when Dr. Schenck diagnosed Ambien-induced sleep-related eating disorder. Another woman who has complained about sleep-eating was Helen Cary, a labor and delivery nurse in Dickson, Tenn., who began taking the drug so she could sleep days while working 12-hour night shifts. "I'm very ambivalent about this drug," said Ms. Cary, 57. "Without it, I would never have survived five years of night shift." But Ms. Cary said her behavior became strange while under Ambien's influence. "One day," she said, "I got up — my husband describes this in great detail — I got a package of hamburger buns and I just tore it open like a grizzly bear and just stood there and ate the whole package. He said a couple things to me and then he realized I was asleep." She has switched to working days and no longer takes Ambien. Two other women who said that they became sleep-eaters while under Ambien's influence were among four former Ambien users who filed suit against Sanofi-Aventis in United States District Court in Manhattan last week, contending they were harmed by the drug. A lawyer handling the case held a news conference yesterday in Manhattan. Ms. Pobre, though, says she still takes Ambien. Without it, she says she cannot sleep at all, and no other sleeping medications work for her. But Dr. Schenck, whom she consulted to find a cure for her problems, also prescribed Topamax, a drug normally used to control epilepsy, that reduces her sleep-eating behavior. "I just hope that maybe they'll come up with something that's better," Ms. Pobre said. "It's just very, very frightening."