Sleeplessness is complicated—but that hasn’t stopped millions of Americans from craving a simple, chemical solution.  

In a recent Consumer Reports survey of more than 4,023 U.S. adults, 37 percent of people who complained of sleep problems at least once per week said they had used an over-the-counter or prescription sleep drug in the previous year.

And why wouldn’t they? The Food and Drug Administration has approved the drugs to treat sleep problems, which means the agency has determined that their benefits outweigh the risks.

“But those benefits aren’t as great as many people assume, and the drugs have important harms,” says Lisa Schwartz, M.D., a drug-safety expert at Dartmouth’s Geisel School of Medicine in Hanover, N.H., who has worked with Consumer Reports Best Buy Drugs on investigating sleeping-pill effectiveness and safety.

What’s more, our survey found that about half of people who take sleep aids use the drugs in potentially harmful ways—by, for example, taking them more often or longer than recommended, or combining them with other medications or supplements.  



Limited Benefits

Best Buy Drugs commissioned Schwartz—who in 2013 served on an FDA advisory committee that looked at the new insomnia drug suvorexant (Belsomra)—and her colleague, Steven Woloshin, M.D., to review the evidence the FDA used to approve the drug. 

They concluded that people who took a 15- or 20-milligram dose of Belsomra every night for three months fell asleep just 6 minutes faster on average than those who took a placebo. And those on Belsomra slept on average only 16 minutes longer than people given a placebo.

Such small improvements didn’t translate to people feeling more awake the next day, either. Instead, more people who took Belsomra reported that they felt drowsy the next day than those who took a placebo.

Merck, the drug’s manufacturer, said in a statement, “We believe our clinical data and FDA-approved prescribing information clearly demonstrates the value of Belsomra.”

A previous Best Buy Drugs analysis of other prescription sleep drugs—so-called Z drugs such as eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien)—found that they, too, provided modest benefits. It found that people fell asleep, generally, between 8 and 20 minutes faster when taking those drugs than when compared with a placebo.

Older prescription sleep drugs known as benzodiazepines (including Dalmane and Restoril), as well as over-­the-­counter sleep drugs such as Advil PM, Nytol, Sominex, Tylenol PM, and ZzzQuil, generally aren’t any better than newer drugs at helping people fall asleep or stay asleep.  

The ‘Morning After’ Effect

Even when taken as directed, sleeping pills pose risks, including next-day drowsiness. 

“People take sleeping pills hoping that they will function better the next day,” Schwartz says. “But some people actually end up functioning worse—so drowsy, in fact, that driving can be dangerous­—because the effects of the drug can linger.”

A study published online in June 2015 by the American Journal of Public Health found that people prescribed sleeping pills were around twice as likely to be in car crashes as other people. The researchers estimated that people taking sleep drugs were as likely to have a car crash as those driving with a blood alcohol level above the legal limit.

Several sleeping-pill instructions caution users to take the medications only if they can stay in bed for at least 7 to 8 hours. And to address the dangers of next-day drowsiness, the FDA has cut in half the recommended doses for Ambien and Lunesta. The labels for Ambien CR and Belsomra 20 milligrams, in fact, caution against driving at all the day after taking the pill. Yet our survey found that about a quarter of sleep-aid users drove with less than 7 hours of sleep at least once in the previous year.

The Risky Business of Rx Sleep Drugs

The need for slumber drives people to use sleep drugs in potentially dangerous ways, according to a nationally representative survey of 4,023 U.S. adults conducted by Consumer Reports in June 2015. As shown in the graphic below, survey respondents who used over-the-counter or prescription sleep aids told us that at least once in the previous year they:

The Dark Side

Sleeping pills can pose other dangers, too, including dizziness, falls, and fractures. “These drugs are known to have a hangover effect that impairs coordination and balance into the next day, especially in older adults,” says Ariel Green, M.D., a geriatrician at the Johns Hopkins University School of Medicine in Baltimore.

Even over-the-counter sleep aids—such as Advil PM, Sominex, and ZzzQuil—pose risks, including daytime drowsiness, confusion, constipation, dry mouth, and problems urinating.

Safer Use of Sleeping Pills

Because of the limited benefits and substantial risks of sleeping pills, Consumer Reports’ medical experts advise that sleep drugs should be used with great caution. The American Academy of Sleep Medicine no longer recommends sleeping drugs as a first-choice treatment for chronic insomnia, opting instead for cognitive behavioral therapy for insomnia (see “The Best (And Natural) Way to Sleep Better” to read more.)

In general, sleeping pills should be reserved for short-term insomnia—such as that caused by jet lag, anxiety after the death of a family member, or job loss—says Watson at the AASM. For those limited situations, CR experts recommend following these precautions, which apply to prescription and over-the-counter sleep drugs:

  • Tell your doctor about all of the medications you take, including supplements. Many common drugs, such as certain antibiotics and antidepressants, can interact dangerously with sleep drugs.
  • Take the drugs only if you have time for at least 7 or 8 hours of sleep. Even if you’ve had that much sleep, don’t drive if you feel drowsy.
  • Do not take an extra dose if you wake up in the middle of the night.
  • Never mix sleeping pills with alcohol, recreational drugs, or other sleep drugs or supplements, including over-the-counter nighttime pain relievers and antihistamines, such as Benadryl Allergy, that contain the sedative diphenhydramine.
  • Start with the lowest recommended dose, especially until you know how the drug affects you.
  • Be cautious about frequent use. Taking sleep drugs regularly can breed dependence and raise the risk of adverse effects. 

Editor's Note: This article also appeared in the February 2016 issue of Consumer Reports magazine.

These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).