A March 2 class action alleges the sleeping pill Ambien caused users to engage in dangerous behaviors they do not remember, including binge eating, crashing a car, and shoplifting (Makinen v. Sanofi-Synthelabo, S.D.N.Y., No. 06-1762, filed 3/2/06).

According to the complaint, Ambien causes somnambulism (sleepwalking), a hypnotic state, and amnestic nocturnal eating behavior (binge eating). One class member alleged she was sexually assaulted twice by a neighbor while she was in a trance-like state after taking Ambien. Another class member was arrested for shoplifting a DVD, and now faces the loss of a 17-year military career. She has no memory of the incident, the complaint asserted.

Scientific evidence links the drug to sleepwalking and binge-eating, the complaint said, yet the defendants failed to test Ambien, failed to warn about its side effects, and failed to monitor and investigate reports of these adverse effects.

Suit Names French Manufacturer, U.S. Subsidiary.

Filed in the U.S. District Court for the Southern District of New York, the suit named Ambien manufacturer Sanofi-Synthelabo, a French corporation, and its U.S. subsidiary, Sanofi-Synthelabo Inc.

The class consists of all persons in the United States who have ingested Ambien from 2000 to date and experienced the side effects of binge eating and sleepwalking in which they were harmed as a result of these side effects.

According to the complaint, more than 1,000 people have suffered harm caused by Ambien. "Plaintiffs represent an even larger number of class members who have yet to discover that they have been or will be injured as for the most part the side effect of Ambien is amnesia when amnestic nocturnal eating behavior and somnambulism occur," the complaint said.

Common questions of law include the defendants' liability for manufacturing, producing, selling and/or distributing Ambien. Common questions of fact include the available scientific and technical knowledge of amnestic nocturnal eating behavior and somnambulism when Ambien was manufactured and sold, the defendants' knowledge or reason to know of the drug's health risks, and failure to test the drug and to warn consumers of risks.

The plaintiffs' claims typify those of class members and derive from a common nucleus of operative facts in that Ambien was prescribed to the plaintiffs and caused them to enter into an "auto-pilot"-like state. It caused them to operate dangerous machinery and vehicles; binge eat; and engage in activities they have no memory of, resulting in damage to themselves, their careers, and to others, the complaint said.

Binge Eating.

Janet Makinen was first prescribed Ambien in 1998, at a dose of 10 mg before bedtime, the complaint said. She took it until June 2005. About two weeks after taking Ambien as prescribed, Makinen began walking in her sleep to her kitchen. There she would eat large amounts of food, including raw eggs, uncooked rice, loaves of bread, bags of chips and candy, and cans of vegetables.

According to the complaint, Makinen would wake up about an hour later, vomiting. She gained a substantial amount of weight, and suffers from various gastrointestinal problems a result of the side effects from Ambien.

Once she stopped taking Ambien, Makinen's sleepwalking and nocturnal eating stopped.

Shoplifting Arrest.

Judith Renee Laswell was a U.S. Navy lieutenant, stationed in Florida. She was prescribed 10 mg dosage of Ambien in February 2005.

One night, after taking the drug for a few days, Laswell entered into somnambulism. She got dressed and walked to the intelligence center of the naval base, "where she worked in a stumbling almost drunken state, talking nonsense with her coworkers," the complaint said. Her co-workers walked her back to her barracks, put her to bed, and told her about the incident the following day. Laswell has no memory of this incident, the complaint said.

Laswell also has no memory of several incidents in which she was arrested for shoplifting.

On Sept. 23, 2005, Laswell took Ambien at about 6 a.m. to go to sleep for the rest of the day. She never fell asleep but instead went to the post office to mail packages, went to the base library and returned overdue books and checked out two DVDs, and then believes she went to the dry cleaners and then to the base exchange with a DVD to return to the store for a refund. The base police handcuffed her and charged her with shoplifting DVDs and a candle.

According to the complaint, Laswell remembers only pieces of what happened that day. She faces larceny charges and her top-secret security clearance was revoked over the incident with the DVDs. She also faces a possible dishonorable discharge from the Navy after 17 years and the loss of substantial severance pay and pension benefits.

Car Accident.

Plaintiff Christina Brothers, a financial analyst, was prescribed Ambien 10 mg in May 2005. On the third day after starting her prescription, she took her dosage at around 1:57 a.m. after retiring to bed. The next thing she remembers, the complaint said, is waking up in a jail cell.

Brothers entered into somnambulism and discovered later from the police report that she got out of bed at about 6 a.m., left her house, drove her mother's car into a parked vehicle and left that scene. She then ran into another vehicle and left that scene. She returned home as if nothing had happened, had a conversation with her mother, and was arrested in her bedroom that morning.

Sexual Assault Victim.

Kathleen M. Callahan, a hematology lab technician, took Ambien intermittently from 2003 through January 2005. She experienced both nocturnal eating and sleepwalking as side effects.

"There were times when she found her refrigerator door open, crumbs on the floor and her hands had chocolate icing on them and a ring of chocolate around her mouth," the complaint said.

In September 2004, Callahan took her prescribed dose of Ambien and quickly fell asleep in a chair in front of the television. She entered somnambulism and opened her door for a neighbor, who sexually assaulted her. Callahan has no memory of that event, the complaint said.

Callahan was sexually assaulted again in January 2005. She remembers only being driven in her car by her neighbor, the neighbor pushing food at her, being pulled backward and trying to pull herself away, trying to cover herself with her lab coat, and her neighbor coming out of her bathroom. The matter is being handled by the district attorney as a sexual assault, the complaint said.

Scientific studies have linked Ambien to sleepwalking and sleep-eating, the complaint said, citing articles in medical journals.

The defendants sold the drug despite knowing it could cause eating behavior and sleepwalking. They were aware or should have been aware of studies linking Ambien to its side effects of sleepwalking and sleep-eating but continued to market it with no warning.

According to the complaint, the defendants failed to train class members and their physicians about the signs and symptoms of adverse reactions, and failed to acknowledge responsibility for adverse side effects, contributing to the false impression that the drug is safe.

The complaint asserts counts in negligence, strict liability, breach of implied warranty, fraud, unfair trade practices, and breach of express warranty.

The plaintiffs are represented by Susan C. Lask of New York.