According
to the Centers for Disease Control and Prevention (CDC), more than one-third of
adults get less than the seven to nine hours of sleep typically needed by most
people. This translates into 50 to 70 million Americans experiencing
sleep deprivation and sleep disorders. For many, the solution comes in
the form of a sleeping pill or two.
At least 8.6 million Americans take
prescription sleeping pills. This may sound so common as to be innocuous.
However, for many of those taking certain prescription sleeping pills at night,
that is far from true.
Researchers
at the University of Washington’s School of Pharmacy found that some patients
using one of three popular nighttime prescription sleeping pills had between a 25%
and three times higher risk of being in a car accident. These findings
support a 2013 advisory warning from the Food and Drug Administration (FDA)
which suggested recommended dosages be changed to reduce the residual effect of
the medication in the patient’s system the next morning.
Car
Accident Risks Vary by Prescription Sleeping Pills
In the
recent study, three popular prescription sleeping pills were evaluated:
Restoril, Ambien and Oleptro. Each works differently in the body to
facilitate sleep. It was found that the risk of being in a car accident
when using these prescriptions varied from 27% with Restoril , to 91% with
Ambien when used over a five year period. This equates to a blood alcohol
content of 0.06 percent and 0.11 percent. The legal limit in all states
for alcohol is 0.08 percent.
The risk
factors include night awakenings, when patients wake and drive in the middle of
the night without recalling the event. Patients also may wake up in the
morning and drive to work, not realizing they are still sedated from the
medication. The drugs remain in the bloodstream for longer than most
people realize, and may impair a driver’s reaction time in challenging driving
situations. Ambien specifically has a warning on the label recommending
patients do not take it unless they can commit to seven-eight hours of sleep
after ingesting it. Patients should consult their physician or pharmacist about
taking the lowest recommended dosage of a prescription sleeping pill.
Sleeping pills such as Ambien and Restoril may
double someone's risk of a car crash — even after their effects should
have worn off — and may raise the risk as much as having too much to
drink, researchers reported Thursday.
A close look at medical and driving records showed that people who took any one of the three popular sleeping aids had anywhere between a 25 percent and three times higher risk of being involved in an accident while driving.
"We found that each of the medications independently was associated with an increased risk of motor vehicle crashes," Ryan Hansen of the University of Washington's school of pharmacy, who led the study, told NBC News.
The findings, published in the American Journal of Public Health, help justify U.S. Food and Drug Administration warnings about the pills.
In 2013, the FDA told makers to cut the recommended doses of sleeping pills because of research showing they can stay in the bloodstream at levels high enough to interfere with morning driving, which increases the risk of car accidents.
The FDA said doctors should aim to prescribe the lowest possible dose.
Hansen's team looked at the medical records and driving records of more than 400,000 people enrolled in a health plan in the state. They chose only adults who were also drivers.
Of them, just under 6 percent were written new prescriptions for sleeping aids between 2003 and 2008.
They collected data on the three pills: zolpidem, sold under the brand name Ambien; trazodone, sometimes sold under the brand name Oleptro; and temazepam, brand name Restoril. Each works through a different mechanism to help people sleep.
People who took Restoril had a 27 percent higher risk of being involved in a crash over the five years studied. People who took trazodone or Desyrel had nearly double the risk — 91 percent higher. Ambien users had the highest risk — they were more than twice as likely as non-users to have a car crash over the five years.
A close look at medical and driving records showed that people who took any one of the three popular sleeping aids had anywhere between a 25 percent and three times higher risk of being involved in an accident while driving.
"We found that each of the medications independently was associated with an increased risk of motor vehicle crashes," Ryan Hansen of the University of Washington's school of pharmacy, who led the study, told NBC News.
The findings, published in the American Journal of Public Health, help justify U.S. Food and Drug Administration warnings about the pills.
In 2013, the FDA told makers to cut the recommended doses of sleeping pills because of research showing they can stay in the bloodstream at levels high enough to interfere with morning driving, which increases the risk of car accidents.
The FDA said doctors should aim to prescribe the lowest possible dose.
Hansen's team looked at the medical records and driving records of more than 400,000 people enrolled in a health plan in the state. They chose only adults who were also drivers.
Of them, just under 6 percent were written new prescriptions for sleeping aids between 2003 and 2008.
They collected data on the three pills: zolpidem, sold under the brand name Ambien; trazodone, sometimes sold under the brand name Oleptro; and temazepam, brand name Restoril. Each works through a different mechanism to help people sleep.
People who took Restoril had a 27 percent higher risk of being involved in a crash over the five years studied. People who took trazodone or Desyrel had nearly double the risk — 91 percent higher. Ambien users had the highest risk — they were more than twice as likely as non-users to have a car crash over the five years.
The effect wears off over time, the researchers found. It may be that people get used to the effects, or they may compensate for them.
"In our study we were just looking at new users of these medications," Hansen said. "We found that over time, the risk increased and it varied from medication to medication, but there was a cumulative effect that then waned after a period of time as well."
What's going on? It seems that people stay sleepy when they use sedatives, the researchers said.
These drugs stay in the blood for a long time, researchers know. "And so, they can have a variety of impacts on risk of crash, including people waking up in the middle of night without knowing it and driving, or waking up in the morning and driving to work and being slightly impaired by the medication still," Hansen said.
"These drugs can make you slow to react to complex situations in driving."
Mallinckrodt Pharmaceuticals, which makes Restoril, said it could not comment specifically on the study without further review.
"Mallinckrodt believes it's medications are safe and effective when used according to product labeling. We encourage patients and healthcare providers to discuss warnings and precautions that may be associated with any drug," the company said in a statement.
Sanofi, which makes Ambien, says virtually all prescriptions of the drug use a generic version now.
"It is important that patients only take zolpidem as directed by their physician. The FDA-approved label states do not take zolpidem unless you are able to stay in bed a full night (7-8 hours) before you must be active again," Sanofi said in a statement.
Ambien, especially, has been reported to cause strange side-effects in users, including sleep walking and taking part in other activities, including driving, with no memory of having done so afterwards.
"I hope that people who are taking these medications, who need to take these medications, will take a moment to talk to their doctor and pharmacist and really better understand the risks that are associated with this," Hansen said.
"It's not just a risk to them, if they're out there driving. It's also a risk to each and every one of us that's out on the road with people who are taking the medications."
At least 8.6 million Americans take prescription sleeping pills and between 50 million and 70 million Americans suffer from sleep disorders or sleep deprivation, according to the Institute of Medicine. Adults typically need between seven and nine hours of sleep a night, but more than a third of adults get less, according to the Centers for Disease Control and Prevention.