March 15, 2006 -- Janet Makinen took Ambien for six years and never understood why she was sleepwalking and eating bizarre things like raw eggs, uncooked yellow rice, and loaves of bread while she slept. Only her husband knew about her problem, but as soon as she told her doctor, he took her off the sleep medication and the sleepwalking ended.
Makinen, 55, of Dade City, Fla., is one of about 100 people involved in a class-action lawsuit against Sanofi-Aventis, the company that makes Ambien. The suit was filed in federal court on March 6.
"Since we filed, I've heard from more than 100 people all over the country," said Susan Chana Lask, the lawyer who is representing the plaintiffs. "Housewives, people in all lines of work, and they all have the same story. Out of 26 million users, 1 percent is a large number and if they're out there driving and hitting people -- multiply that number by two."
Ambien is an extremely popular prescription sleep medication. In 2005, 26.5 million prescriptions were filled and sales reached $2.2 billion. Prescriptions have risen 53 percent since 2001. Nevertheless, it is one of the Top 10 drugs found in impaired drivers.
Makinen suffered from insomnia all her life and thought Ambien would be her saving grace. Once the nighttime binge eating began, she started gaining weight and eventually went from a size 1 to a size 12. When her husband tried to stop her at night, she became irate.
"My husband would sometimes find me laying in bed with my mouth stuffed with food, and he'd have to shovel it out," Makinen said. "He was the only one who knew about it, and he tried to stop it by hiding food from me."
A Mayo Clinic researcher found many cases of people who sleepwalk and sleep-eat after taking Ambien, which was approved by the Food and Drug Administration in 1993. When Ambien users discontinue the drug, the sleep-eating episodes stop, a researcher found. Sanofi-Aventis said that the side effect was known but rare, and that "when taken as prescribed, Ambien is a safe and effective treatment for insomnia." The company said the side effect was disclosed in the product's full labeling material. Even still, doctors have told the FDA that patients show more sleepwalking incidents with Ambien than with all other sleep aids combined.
"A lot of times after returning to bed, I'd wake up vomiting because I had so much food in my stomach," Makinen said. "I'll probably be taking meds for the stomach problems for the rest of my life. It was like being an abused wife, you just stay with it. That's why it took so long for me to stop taking Ambien."
Like Makinen, Brenda Pobre spent years gaining pound after pound. She topped out at 346 but never thought that her sleep medication was to blame until her doctors figured it out.
"It's the most frustrating thing in the world to be doing everything right to lose weight and to still have the results be wrong," she said. "After I started on the Ambien, I gained at least a hundred pounds."
Dr. Mark Mahowald at the Minnesota Regional Sleep Disorders Center is studying 32 Ambien-related cases. Most of the sleep-eaters are women. Doctors aren't sure why the phenomenon seems to happen more often with sleeping pills.
"We've had people eat buttered cigarettes. We've had people make salt sandwiches," he said. "It's a release of two innate behaviors, namely sleep and eating and they're both released at the same time by the sleeping medication."
Like Makinen, Pobre took awhile to discover the root of her mysterious weight gain. But when she did, she stopped taking the drug.
"It went on for a couple of years," she said. "It seems that it took forever for me to find the answers."