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Sleeping Pills Get Black Box Warning Following Accidental Deaths

If you have trouble sleeping, you're not alone. According to SleepHealth.org, 70% of American adults say they get insufficient sleep at least one night per month, and 11% struggle to get sufficient sleep on a nightly basis.1 As noted by this organization: 

“Sleepiness affects vigilance, reaction times, learning abilities, alertness, mood, hand-eye coordination, and the accuracy of short-term memory. Sleepiness has been identified as the cause of a growing number of on-the-job accidents, automobile crashes and multi-model transportation tragedies.”

However, reaching for a sleeping pill may be just as dangerous as not getting enough sleep. 

Sleep Drugs Safety Announcement

April 30, 2019, the U.S. Food and Drug Administration (FDA) announced2 it will require sedative-hypnotics — a class of sleep medication used to treat insomnia — to carry a black box warning stating drug side effects may include dangerous behaviors done while sleeping, such as eating, walking, driving or engaging in a range of activities in your sleep that can lead to injury or death. According to the FDA:3

“These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.

As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. 

We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.

Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. 

These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.”

Patients who experience an episode of activity while not fully awake, or find they cannot recall an activity that occurred while taking the medicine, are advised to stop taking the drug immediately and to contact their doctor. 

Popular Sleep Drugs Linked to Accidental Fatalities  

Over the past 26 years, there have been 66 documented reports of “complex sleep behaviors” occurring in patients on these drugs, the FDA says, 20 of which were fatal. These reports included:4

Accidental drug overdose

Falls

Burns

Near drowning and drowning

Exposure to extreme cold, resulting in amputation of a limb

Hypothermia 

Carbon monoxide poisoning

Car accidents, where sleeping patient was driving

Self-inflicted gunshot wounds

Unintentional suicide attempts

Research5 has also shown that those who take hypnotic sleep aids (including zolpidem, temazepam, eszopiclone, zaleplon, benzodiazepines, barbiturates and sedative antihistamines) on a regular basis are significantly more likely to die over the course of 2.5 years than nonusers, and the link is dose dependent. 

Patients prescribed 0.4 to 18 doses per year raised their risk of death by 360%; those taking 18 to 132 doses per year had a 443% greater risk, while those taking in excess of 132 doses were 5.36 times (536%) more likely to die. Heavy users were also found to have a higher risk of cancer. 

As noted by the authors, “Receiving hypnotic prescriptions was associated with greater than threefold increased hazards of death even when prescribed [less than] <18 pills/year.” Other studies have reached similar conclusions. For example:

• A Norwegian study6 published in 2007, which included data from 14,451 men and women aged 40 to 42 who were followed for 18 years, found frequent use of sleeping pills increased men’s risk of death by 150% and women’s risk by 170%, after adjusting for confounding factors. 

• A 2009 Swedish study,7 which followed a cohort of 3,523 men and women aged 30 to 65 for 20 years, found regular use of hypnotics raised all-cause mortality by 454% in men and 203% in women. 

According to the authors, “With regard to cause-specific mortality, regular hypnotic usage in men was a risk factor for coronary artery disease death, cancer death, suicide and death from "all remaining causes." In women it was a risk factor for suicide.”

• A 2010 Canadian study8 of 14,117 people between the ages of 18 and 102 found those who used sleeping pills were 1.36 times (136%) more likely to die than nonusers.

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