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Ambien Zombies

No doubt as nurses, we have an amusing “Ambien” story or two we could tell.  From the drug induced bazaar ramblings of patients to nudity filled escapades around the nurse’s station. Typically we would characterize this as an adverse drug reaction.   For most who react negatively to the drug it is merely embarrassing events; incoherent emails, odd-conversations, the cooking and eating of strange concoctions of food and non-food substances. But on closer examination a long list of bizarre and more sinister behaviors are emerging after the use of this hypnotic.  A tragic trend appears as reports of assault, sleep-driving, vehicular manslaughter, murder and even mass murders have occurred after taking Ambien.

“On March 29, 2009, Robert Stewart, 45, stormed into the Pinelake Health and Rehab nursing home in Carthage, North Carolina and opened fire, killing eight people and wounding two. Stewart’s apparent target was his estranged wife, who worked as a nurse in the home. She hid in a bathroom and was unharmed. Stewart was charged with eight counts of first-degree murder; if convicted, he could face the death penalty. Stewart’s defense team successfully argued that since he was under the influence of Ambien, a sleep aid, at the time of the shooting, he was not in control of his actions. 

In March of 2011, Lindsey Schweigert took one Ambien before getting into bed at 6pm. Hours later, she woke up in custody with no idea how she’d gotten there. In the following weeks, Schweigert pieced together the events of that night. She’d gotten out of bed, drawn a bath, and left the house with her dog. She started driving to a local restaurant but crashed into another car soon after leaving her house. Police described her as swaying and glassy-eyed. She failed a sobriety test and was charged with DWI and running a stoplight.

In April of 2009, Julie Ann Bronson a 45 year old flight attendant from Texas, took a couple of Ambien to help her sleep. She had been drinking wine earlier in the day, and went to bed early. She awoke the following morning in jail, still in her pajamas, barefoot and terrified. When she was told that she had run over three people, including an 18-month-old girl who suffered severe brain damage as a result of the wreck, she was horrified.

Ambien, a member of the class of medications known as hypnotics, was approved by the FDA in 1992. It was designed for short term use to combat insomnia and was a welcome change from the prevailing sleep aid at the time, Halcion, which had been implicated in psychosis, suicide, and addiction and had been banned in half a dozen countries. Ambien works by activating the neurotransmitter GABA and binding it to the GABA receptors in the same location as the benzodiazepines such as Xanax and Valium. The extra GABA activity triggered by the drug inhibits the neuron activity that is associated with insomnia. In other words, it slows down the brain. Ambien is extremely effective at initiating sleep, usually working within 20 minutes. It does not, however, have an effect on sustaining sleep unless it is taken in the controlled release form.

After its approval, Ambien quickly rose to dominance in the sleep aid market. Travelers swore by it to combat jet lag, and women, who suffer more insomnia than men, bought it in droves. Sanofi, Ambien’s French manufacturer, made $2 billion in sales at its peak. In 2007 the generic version of Ambien was released, Zolpidem, and at less than $2 per pill, it still remains one of the most prescribed drugs in America, outselling popular painkillers like Percocet and prescription strength ibuprofen.

Although the Ambien prescribing information warned, in small print, that medications in the hypnotic class had occasional side effects including sleep walking, “abnormal thinking,” and “strange behavior,” these behaviors were listed as extremely rare, and any anecdotal evidence of “sleep driving,” “sleep eating,” or “sleep shopping”—all behaviors now associated with Ambien blackouts—were characterized as unusual quirks, or attributed to mixing the medication with alcohol. It wasn’t until Patrick Kennedy’s 2006 middle-of-the-night car accident and subsequent explanation to arriving officers that he was running late for a vote that the bizarre side effects of Ambien began to receive national attention. Kennedy claimed that he had taken the sleep aid and had no recollection of the events that night.
Shortly after the Kennedy incident, Ambien users sued Sanofi because of bizarre sleep-eating behaviors while on the drugs. According to Susan Chana Lask, attorney for the class action suit, people were eating things like buttered cigarettes and eggs, complete with the shells, while under the influence of Ambien. Lask called people in this state “Ambien zombies.” As a result of the lawsuit, and of increasing reports coming in about “sleep driving,” the FDA ordered all hypnotics to issue stronger warnings on their labels.

The DEA categorizes drugs according to their potential for abuse and addiction. Schedule I drugs are the most likely to be abused, and Schedule V drugs have the least potential for abuse or addiction. Ambien is a schedule IV drug, and can be prescribed and refilled without restriction. Some toxicologists, such as Janci Lindsay, believe that many Ambien-related tragedies would be avoided if the drug were upgraded to Schedule II, a category that includes controlled substances such as Ritalin and Oxycontin. Other countries, such as Australia, Taiwan, and Japan, have all issued special warnings about Ambien and have begun regulating the drug more carefully ever since reports started surfacing about “potentially dangerous” Ambien-induced behaviors.”

Click the link to read the original Huffington Post article in its entirety “The Disturbing Side Effect of Ambien, the No. 1 Prescription Sleep Aid”

In addition to giving consumers extra information so they could take the medication more carefully, the warning labels also gave legitimacy to the Ambien Zombie defense. Still, many judges and prosecutors find the notion of sleep-driving inherently implausible despite FDA recognition that it can, and does, happen. The legal dockets are filled with such cases.

“Troubled and angered over what happened to her, Lindsey Schweigert consulted with a civil attorney and reported her incident to the FDA and to Anchen Pharmaceuticals, the maker of the generic Ambien that caused her to sleep-drive. But neither seemed particularly interested in her story. The FDA filed Schweigert's complaint in a database called MedWatch, which collects reports about serious drug side effects. But the database relies heavily on voluntary disclosure from physicians, pharmacists, patients, and drug companies. The system is poorly organized and riddled with misspellings, making it difficult for the agency to draw meaningful conclusions. Ambien, for example, is entered under 442 different names, including Ambiennn.

The MedWatch database includes 1,350 reports of sleepwalking, road traffic accidents, or impaired driving between January 2004 and September 2011 in which Ambien or Zolpidem is listed as the primary cause, according to data provider AdverseEvents. That may not sound like a lot when it comes to a drug prescribed more than 35 million times a year, but it's clearly the tip of a much larger problem: A U.S. Government Accountability Office investigation into FDA monitoring of drugs post-approval says the agency's database captures only an estimated 1 to 10 percent of all adverse reactions. And as researchers point out, because Ambien-induced sleep behaviors are accompanied by amnesia, it's even more likely that they're underreported. "It's widely known that the actual incidence of adverse reactions is far greater than the number of reports submitted to the FDA. So 1,350 reports represents thousands of incidents," says drug-safety expert Dr. Nicholas Tatonetti, assistant professor of biomedical informatics at Columbia University.”

Click the title to read the original article “While You Were Sleeping”

Additional Sources:
Med Page Today: Murder: Another Ambien Side Effect?
http://www.medpagetoday.com/MeetingCoverage/APA/45637
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