If you have trouble sleeping and your doctor has prescribed a medication to aid your sleep, you may want to keep reading because three oft-prescribed sleep drugs have been ordered to now carry a black box warning, according to the Food and Drug Administration (FDA). A “box warning,” often called a “black box warning,” is the agency’s most serious warning, and it’s displayed prominently on the label of the prescription medication. Pharmacytimes.com describes a box warning as follows:
If you have trouble sleeping and your doctor has prescribed a medication to aid your sleep, you may want to keep reading because three oft-prescribed sleep drugs have been ordered to now carry a black box warning, according to the Food and Drug Administration (FDA). A “box warning,” often called a “black box warning,” is the agency’s most serious warning, and it’s displayed prominently on the label of the prescription medication. Pharmacytimes.com describes a box warning as follows:
“Black box warnings are the strictest labeling requirements that the FDA can mandate for prescription drugs. First implemented in 1979, black box warnings highlight serious and sometimes life-threatening adverse drug reactions within the labeling of prescription drug products. These safety concerns are generally identified through the FDA’s Adverse Event Reporting System and Office of Surveillance and Epidemiology…Sometimes, however, a black box warning is handed down right at the time when a new drug is approved.”
The three sleep medications now required to carry a box warnings are Ambien (zolpidem), Lunesta (eszopiclone), and Sonata (zeloplon). Zolpidem comes in many brand name forms in addition to Ambien including Ambien CR, Edluar, Intermezzo, and Zolpimist.
Serious Adverse Effects
Serious and even fatal side effects have been seen in these drugs. The FDA’s recent announcement was prompted by nearly 70 reports over a 26-year period of adverse effects including sleepwalking and, ironically, sleep deprivation. In 40 of the cases reported, people taking these medications for sleep issues were involved in serious incidents that included near-drowning, firearms accidents, hypothermia, and frostbite among people who simply wandered outdoors on frigid nights. Twenty of the cases were fatal, and involved drowning, motor vehicle crashes, carbon monoxide poisoning, and possible suicide.
For many years, people have joked about doing crazy (and often dangerous) things after taking Ambien; some people claim to get up and prepare full meals while sound asleep, and others report getting in their car and driving while sleeping and remembering none of it the next day. What has been joked about in the past is now a very serious matter because people are getting seriously injured and dying after taking these sleep medications.
An article in The Primary Care Companion for CNS Disorders described an incident in which two people taking a sleep medication murdered their spouses after taking the drug and neither one had any recollection of what they had done. Neither of the people who killed their spouse had ever showed any evidence of violent, aggressive behavior.
The number of “sleepwalking” incidents after taking Ambien, Sonata, or Lunesta is most likely severely underreported because many people will not remember what they did after taking the drugs and falling asleep. If there are no witnesses present to document the behavior, then no report will be made.
Previous Warning on Sleep Meds
This is not the first time a warning has been given to these drugs. A similar, less prominent warning was issued in 2007, and in 2013, the FDA ordered drug manufacturers to lower the recommended dosage for women, who appear to be more at risk for serious side effects. Now, here we are 12 years after the initial warning, and these drugs are finally getting the black box warning that maybe should have been issued long ago.
If you or someone you love is taking Ambien, Lunesta, or Sonata, please discuss the drug’s safety with your physician. If you have suffered injury or a loved one has died due to one of these dangerous sleep medications, you should contact a personal injury attorney who handles these complex dangerous drug cases.