Ambien users filing lawsuits over side effects

St. Louis Daily Record & St. Louis Countian, Apr 15, 2006 by Nora Lockwood Tooher

The following article was originally published in Lawyers Weekly USA, a sister publication.

BOSTON - Janet Makinen, a Florida housewife, was prescribed Ambien in 1998 for insomnia. About two weeks later, she began walking in her sleep to her kitchen and devouring food.

It didn't matter what kind of food, either. Makinen, 55, of Dade City, Fla., wolfed down raw eggs, uncooked rice, cans of vegetables, loaves of bread, and bags of chips and candy.

An hour after her binge-eating, she'd wake up vomiting.

Makinen gained so much weight from the nocturnal feedings that she ballooned from a size 1 to a size 12. She still suffers from stomach problems, including an ulcer.

She stopped taking Ambien in 2005. And now she's suing Sanofi- Aventis, the manufacturer of the popular prescription sleeping medication.

A class-action suit filed March 6 in U.S. District Court in the Southern District of New York claims that Ambien caused Makinen and hundreds of other users to enter into trance-like states in which they drove cars, binged on food and engaged in other activities they have no memory of.

The suit accuses Sanofi-Aventis of inadequately warning users of the dangers of amnesic sleep-eating, sleepwalking and sleep- driving.

New York attorney Susan Chana Lask, who filed the suit, said that in addition to damages, she wants the manufacturer to provide stronger warnings about Ambien's potential dangers.

As of March 22, about 500 other plaintiffs had joined the suit.

Ambien was introduced to the market in 1993, but its sales have soared in the past few years - due mainly to an intensive consumer advertising campaign.

Last year, an estimated 26.5 million prescriptions were dispensed for Ambien - more than double the number written in 2001 - making it the nation's best-selling prescription sleeping pill.

Lask said she first heard about the phenomenon of amnesic sleep- eating in an e-mail from Makinen.

I thought it was just crazy, Lask recalled. Who sleep-eats?

But she mentioned the e-mail to her legal assistant, who said that she, too, had done some somnambulistic food-foraging.

That's when Lask began researching the possible side effects of Ambien, which turn out to include sleep-eating, sleepwalking and sleep-driving.

She discovered bizarre behavior is not uncommon: They cook full meals, but they're disgusting meals. They're like zombies. They're just shoving things in their mouths. It's this carnal thing.

And the strange behavior that some users exhibit in their sleepwalking states occasionally even lands them in jail - much to their surprise, since amnesia is another documented side effect.

Other plaintiffs named in the class-action suit include:

Judith Renee Lasswell, a Navy lieutenant in Florida who was arrested for shoplifting DVDs and a candle from her naval base. She does not recall the alleged thefts. Her security clearance has been revoked, and she faces larceny charges and dishonorable discharge from the Navy.

Christina Brothers, a financial analyst who was prescribed Ambien for insomnia in May 2005. After three days of taking her prescribed dose, she woke up on the concrete floor of a jail cell. Brothers learned from a police report that she got out of bed around 6 a.m., left her house, drove her mother's car into a parked vehicle, left the scene and ran into another vehicle. She left that scene as well, returned home, had a chat with her mother and was arrested in her bedroom later that morning.

She remembers neither accident, nor anything else from the morning of her arrest.

Kathleen Callahan, a New York lab technician who claims there were mornings when she found her refrigerator door open, crumbs on the floor, chocolate icing on her hands and a ring of chocolate around her mouth. One morning she woke up in bed with her hands in a potato chip box.

Callahan also alleges she was twice sexually assaulted by a neighbor while in a sleepwalking state.

One New York pharmaceutical defense lawyer specializing in class actions, who asked not to be named, said he thinks it is unlikely the New York case will proceed as a class action because physicians receive information about a medication from many different sources and it could be difficult to isolate the communications physicians had with the manufacturer.

Following the recent news reports, Sanofi-Aventis issued a statement saying that sleepwalking occurs in about 4 percent of the adult population, and that while events of sleepwalking have occurred during treatment with Ambien, these instances cannot be systemically linked to the product.

It also said that a recent company analysis concluded that the current prescribing information is accurate: Somnambulism is a possible rare adverse event.

The manufacturer also reminded users that Ambien should only be taken when the user can have eight hours of uninterrupted sleep and that it should never be taken with alcohol.

The Food and Drug Administration says the drug's current warnings are adequate.

David Benjamin, a toxicologist in Newton, Mass., said that while the strange side effects of Ambien are very believable, a product liability suit against the manufacturer faces an uphill challenge.