In April of 2019, the FDA announced a new Black Box warning label for Ambien, Innesta and similar sleep drugs. The Ambien Black Box warning cautions patients the drug causes strange and complex sleep behaviors that can result in serious injury or death. Ambien sleep problems include sleep walking, driving, having sex, cooking and eating, suicide attempts, violent outbursts, and hallucinations. The patient typically has no memory of the experience and can put themselves and others into grave danger while under the influence of Ambien-type sleep drugs.
Ambien and twelve other similar sleep aids fall in a class of drugs known as nonbenzodiaxepines, or "Z-drugs". Used to treat insomnia, Ambien (zolpidem) was first developed by the French pharmaceutical company Sanofi-Aventis in the 1980s as an alternative to sleep medications that caused daytime drowsiness, chemical dependency, and over-sedation. Ambien type sleep drugs, also known as sedative hypnotics, target the brain's GABA receptors in order to increase the brain's capacity to relax.
Insomnia is a huge problem in the United States; in 2018, 44 million prescriptions were filled for sleep drugs. Of these, more than half were for Ambien (27.6 million), while the second-most popular brand name, Lunesta, tallied a distant 5.8 million prescriptions, with sale for Ambien and Lunesta combined exceeding $3 billion. $600 million was spent on advertising, and critics blame aggressive product marketing for these drugs 60% increase in sales since 2000. Overall, Ambien is the 15th most-prescribed drug in this country.
Reports of Ambien type sleep drug problems cropped up soon after the drug hit the market in the United States. Commonly called "Ambien blackouts", patients described incidents in which they would carry out complex tasks - such as getting out of bed, getting car keys, leaving the house, getting into the car, and driving - that occurred all while they were still asleep. Known as parasomnia, Ambien type sleep drug activities occur in some patients after they have taken the drug and settled down in bed for sleep.
Patients have reported a wide range of Ambien sleep drug activities, including:
Why these side effects are rare, they can pose a risk of serious injury or death from Ambien to the patient and others. It is unknown why some patients experience Ambien sleep driving, walking, and other strange sleep behaviors, though it is though that alcohol consumption may make sleep drug problems more likely.
Dr. Mark Mahowald, a sleep forensics expert from the University of Minnesota has been vocal in his warnings about the dangers of Ambien type sleep drugs. "Hopefully this will make doctors think twice before blindly giving patients a prescriptionâ€¦ I personally think the extent of advertising has just been unconscionable."
"Hopefully this will make doctors think twice before blindly giving patients a prescriptionâ€¦ I personally think the extent of advertising has just been unconscionable." â€“ Dr. Mark Mahowald, Sleep Forensics, University of Minnesota
In the decades since Ambien was first approved in the United States, numerous researchers contributed to what we known today about sleep drug side effects. Laura J. Liddicoat, a forensic toxicologist in Wisconsin brought the issue of Ambien sleep driving to the attention of a national conference. Sleep eating was first reported by Dr. Michael Silber at Mayo Clinic's Sleep Disorder Clinic. Dr. Mahowald, along with University of Minnesota Dr. Carlos Schenck, has recorded approximately 30 patients in their practice who have suffered from nighttime eating disorders from Ambien and are considered the experts on this particular Ambien side effect.
Another early report of Ambien nighttime eating, which paints a particularly desperate picture, was recorded in 2006 in the Wisconsin Law Journal. This particular patient was a woman whose Ambien sleep eating became very dangerous: she ate raw eggs, uncooked rice, whole loaves of bread, multiple cans of food, and entire bags of chips and candy. Unconscious of her actions, she woke vomiting and developed an ulcer and severe weight gain as a result of Ambien.
On April 30, 2019, the federal regulators announced it would now require an FDA Black Box sleep drug warning on 13 Ambien type sleep drugs. The new label warns the drugs cause "complex sleeping behaviors" that are rare but have resulted in serious injuries or deaths. The FDA sleep drug warning applies to the following brand name drugs and generics:
The FDA sleep drug warning is based on 46 adverse events, including 20 deaths and 26 serious injuries. Strange sleep behaviors caused the following incidents:
The FDA followed Australia's example in issuing a sleep drug warning statement. Australian officials issued a similar warning for Stilnox (Ambien) in February of 2019. Now, when patients pick up a prescription for Ambien type sleep drugs, they will receive a pamphlet warning of sleep drug dangers. Doctors are advised to discontinue prescriptions after a patient has an initial incident of complex sleep behaviors while under the influence of hypnotic sleep drugs.
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