It has been several years since the bloom fell off the rose of Ambien, the blockbuster sleeping pill. Recently, the FDA has warned about Ambien hangovers, sedation and the risk of dangerous driving and recommended lower doses. The FDA warnings came a year after Kerry Kennedy, daughter of Robert F. Kennedy and former wife of New York Governor Andrew Cuomo, was arrested for what was believed to be Ambien-inebriated driving. The arrest came six years after her cousin, former Rhode Island Congressman Patrick J. Kennedy, son of Sen. Edward Kennedy, was also involved in an apparent Ambien-related traffic mishap.
After Rep. Kennedy's crash, as stories of more bizarre behavior on the sleeping pill surfaced, Ambien's manufacturer Sanofi-Aventis, was forced to launch an ad campaign telling people if they were going to take Ambien, to get in bed and stay there. (Or you'll "break out in handcuffs" as the joke goes.) Reports of driving, eating, sex and other "wakeful" behavior in Ambien blackouts proliferated.
Under the influence of Ambien, people say they have sexted married friends, drawn penises in the middle of their handwriting, ordered expensive and unwanted items online and one person "tried to legally change my name on the computer." One woman I interviewed drank an entire bottle of black shoe polish under the influence of Ambien. Tiger Woods reportedly used it for sex. Dieters report being horrified at the type and amount of foods consumed during an Ambien blackout.
But Ambien blackouts are not just about night-eating and zany behavior—they are as serious as cancer.
In 2012, in San Antonio, Julie Ann Bronson, a 42-year-old flight attendant was tried for running over a mother and her two daughters while "sleep driving." Her life was "ruined" by Ambien, says her lawyer. In 2006, a 36-year-old lawyer from Andover, Massachusetts, was sleep-driving on Ambien when he struck and killed a man who was changing a tire alongside his wife and young son, according to Marie Claire magazine. Two years later, a 56-year-old woman also sleep-driving while on Ambien killed a mother of 11 children.
In 2012, the Mayo clinic in Rochester announced it would no longer prescribe Ambien to inpatients because they are four times as likely to experience falls from the drug. Ambien is also linked to suicide and suicidal thoughts in users.
And the bad news about Ambien continues. This year, a report from the Substance Abuse and Mental Health Services Administration, the agency dedicated to the behavioral health of the nation, found Ambien-related emergency department visits almost doubled from 2009 to 2010 than just four years earlier. Ambien, whose active ingredient, zolpidem, is also found in Ambien CR, Edluar and Zolpimist was responsible for 42,274 visits, says the government, sometimes in conjunction with other drugs and alcohol. Almost half of zolpidem-related ED visits resulted in hospital admission or transfer to another facility and a quarter resulted in intensive care treatment in the ICU.
Seeking a Good Night's Sleep
Americans have always loved their sleeping pills. In the late 1960s, Jacqueline Susann's novel Valley of the Dolls about the addiction of beautiful people to "dolls" or barbiturates was made into a blockbuster movie by the same name starring Sharon Tate, Barbara Parkins and Patty Duke. In the movie, Sharon Tate's character commits suicide on sleeping pills. Marilyn Monroe's death was also attributed to barbiturates.
When Dalmane and Halcion debuted in the next decades, they were thought to be safer than "dolls" but were they? Dalmane, the first drug in the benzodiazepine (Valium, Xanax) family to be explicitly approved for sleep was launched by Hoffmann-La Roche in 1970. But by 2001, government officials with the National Transportation Safety Board at FDA hearings said the drug was likely to “increase the risk of an injurious accident more than five times normal,” foreshadowing the Ambien problems to come and eroding the drug's popularity.
Nipping at Dalmane's heals was Halcion, another benzodiazepine which was introduced in 1982 and believed to be safer. It became the world’s best-selling sleep aid. Like Ambien, Halcion was popular with business travelers fighting jet lag and fatigue on trips and craving a good night's sleep for mental sharpness—except that the drug was rapidly seen to do the opposite. It began to be linked to amnesia, panic and emotional upheavals. Authors William Styron, in his 1990 memoir, Darkness Visible, and Philip Roth, in his book Operation Shylock, cited nightmare-like experiences that occurred from taking Halcion. In 1991, Upjohn, the drug's manufacturer, settled a lawsuit from a woman who shot and killed her 82-year-old mother, claiming the drug was responsible. So much for being safer than barbiturates. The drug was banned in England.
Are Alternative Sleeping Pills Safer?
To both drug makers and those afflicted with insomnia, the barbiturate/Dalmane/Halcion/Ambien sagas reveal two overarching truths: there is a huge market/need for insomnia drugs and the drugs have fallen woefully short when it comes to safety. In fact, thanks to Ambien, new sleeping drug candidates are now assessed on the basis of "next-day driving tests," a welcome but probably tardy development. Alternative sleeping drugs to Ambien such as Lunesta, Sonata and Rozerem have serious drawbacks and side effects in the opinion of patients who have taken them and posted reviews on Askapatient.com. None receives a high rating.
Two years ago, the picture worsened when high users of eight popular sleeping pills, including Restoril, Lunesta, Sonata, Dalmane and Halcion and the older antihistamine diphenhydramine (as well as an unnamed barbiturate and benzodiazepine) were found to have a 5.3-fold higher risk of death according to research conducted in 2012 by Scripps Clinic and published in British Medical Journal Open. They also had a 35 percent higher risk of cancer than non-users. What?
While the research looked at pill users who took at least 132 doses of sleeping pills a year for more than two years, even patients who took between 1 to 18 sleeping pills per year had an elevated risk of death, according to the research.
The researchers confirm this is startling and unexpected news. “What our study shows is that sleeping pills are hazardous to your health and might cause death by contributing to the occurrence of cancer, heart disease and other ailments,” said investigator Daniel F. Kripke, emeritus professor of psychiatry at the University of California, San Diego.
“We tried every practical strategy to make these associations go away, thinking that they could be due to use by people with more health problems, but no matter what we did the associations with higher mortality held,” said co-author Robert D. Langer of the Jackson Hole Center for Preventive Medicine in Jackson, Wyoming.
But this summer, there is a new sleeping pill candidate which will seek to put America to sleep. Belsomra, from Merck, just approved in August may cost as much as $350 to $450 for 30 tablets, speculates one source, but many are hoping it is an Ambien without the side effects. Getting the drug approved was not easy for Merck but it persevered, said the New Yorker, hoping the drug will make billions as a blockbuster.
But there are already questions about the new sleeping drug and not just about its costs, as co-pays are seen to be increasing under some health plans. The drug, suvorexant, impaired next-day driving in subjects at a 20-mg dose so it was approved for a 10-mg dose. But, at the 10 mg dose, there is little evidence it works, say pharmaceutical reporters. Needless to say, patients will be tempted to up their dosages and incur the dangerous sedation they are supposed to avoid. Will that lead to sexting married friends, drinking shoe polish and worse?
by Martha Rosenberg
September 10, 2014