The Problem With Sleeping Pills

The benefits might be smaller than you hoped for, and the risks may be greater

By Consumer Reports
Last updated: January 05, 2016

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).

Trazodone: Common sleep drug is little-known antidepressant

Consumer Reports (August 2015)
http://www.consumerreports.org/cro/2012/04/trazodone-common-sleep-drug-is-little-known-antidepressant/index.htm

What are the top prescribed drugs for insomnia—Ambien? Lunesta? Yes, but there's another: a three-decade-old generic antidepressant called trazodone, which causes drowsiness as a potentially useful side effect. A recent U.S. study in the journal Sleep found it to be one of most commonly used medications to treat sleeplessness.

Trazodone was first approved by the Food and Drug Administration in 1981 as an antidepressant. Though doctors can legally prescribe trazodone (and all drugs, for that matter), for any treatment, the drug is actually not approved to treat insomnia. Today, there's no branded form of trazodone—you can only get it as a generic—but there is a long-acting version available called Oleptro.

In a few studies, trazodone is reported to improve sleep during the first two weeks of treatment. But the drug has not been studied for longer than six weeks, so little is known about how well it works or its safety past that point. Also, an effective dose range has not been studied.

There's very little clinical trial evidence on whether it's effective as a sleep aid when a person does not have depression, and only modest evidence when there is. Treatment guidelines from the American Academy of Sleep Medicine recommend trazodone for chronic insomnia without depression only when drugs like Ambien and Lunesta have failed.

But numerous doctors are convinced, based mainly on their own experience, that trazodone is an appropriate sleep medication for many people, even when there's no depression. Here's why trazodone has become so popular—and what to do if your doctor suggests you try it.

Trazodone: Risks and benefits

While trazodone is rarely used to treat depression alone any more, it's widely prescribed, off-label, at lower doses for treating insomnia, for several likely reasons.

First, trazodone has one distinct advantage—and possibly a few others. It's generic, so it's considerably cheaper than many of the other widely prescribed sleep medications—about $3 for a week's supply. That's compared to other sleep drugs like generic zolpidem (Ambien), generic eszopiclone (Lunesta) or generic Sonata (zalepon) that run about $15 for a week's supply. And while some of the insomnia drugs are classified by the FDA as controlled substances that require doctors and pharmacists to take additional steps before they're prescribed or dispensed; trazodone is not a controlled substance, so doctors can prescribe it without those constraints.

In addition, many physicians apparently believe that trazodone is safer than other frequently prescribed sleep medications. But because there are not studies that actually show it is safer, whether or not that is true remains unknown.

It's true that the other drugs approved to treat insomnia can impair your ability to recall new experiences, and may even—although rarely—cause you to walk, eat, have sex, or drive a car while still essentially unconscious. We could find no evidence to date of those problems having been reported with trazodone. Moreover, many doctors seem to believe that trazodone is less likely than even the newer sleep drugs to cause dependency and, when discontinued, renewed insomnia. Yet there's little evidence to prove or disprove those ideas.

And, trazodone has certain risks of its own. In particular, it's more likely than the newer sleep drugs, particularly the short-acting ones, to leave you feeling drowsy the next day, which increases the chance of accidents. It can also cause abnormally low blood pressure and, in turn, dizziness or even fainting, particularly in seniors.

Trazodone can also cause heart-rhythm disorders. It might possibly weaken the immune system. And some evidence suggests it can cause priapism, or persistent erection, a medical emergency that may require surgery and can lead to impotence if not treated promptly. Moreover, a black-box warning in the package insert notes that trazodone, like other antidepressants, can increase the risk of suicidal thoughts and behavior in children and adolescents.

Trazodone: Should you take it?

For the average person who has occasional brief bouts of insomnia, making certain changes to your lifestyle may help, including: avoiding big meals, alcohol, smoking and exercising late at night or working or watching TV in bed. (See sidebar for a full list.) If those don't work, our medical advisors recommend first trying an inexpensive over-the-counter drug containing an antihistamine such as diphenhydramine (Benadryl, Nytol, Sominex, and generic) or doxylamine (Unisom Nighttime Sleep-Aid and generic)—but only use those for a few nights.

If your insomnia last longer than a few nights and this continues for several weeks, you should see your doctor to determine if other conditions or drug side effects could be disturbing your sleep. If those are ruled out—or if your insomnia persists despite treatment of the underlying problem—nondrug sleep treatments such as cognitive behavioral therapy appear to yield better, more lasting results than medication. If possible, try that before resorting to medication, which can undermine your motivation to make the behavioral changes.

If your doctor recommends sleeping pills for more than a temporary bout of insomnia without mentioning nondrug therapy, you should mention it yourself. For more on such treatment, see our Best Buy Drug report on drugs to treat insomnia.

Of course, medication is sometimes needed for persistent insomnia—when nondrug treatment is refused, unavailable, or ineffective, or when the sleep disturbance is affecting your ability to carry out your daily activities. Here are the main considerations for using drug trazodone to treat insomnia:

• Insomnia without depression. Because there's so little supporting evidence, sleep experts generally recommend trazodone for insomnia only after the newer sleep drugs have failed. Trazodone may improve sleep initially, as found in one small study, but that effect could fade after several weeks. Researchers theorize that this could be due to residual sleepiness in the daytime, so a person is less physically active , which may contribute to the ability to sleep well at night.
• Insomnia with depression. Some conditions, such as depression, have a complex and intertwined relationship with insomnia, and the best treatment for these two issues together has not been determined. If you have both, discuss the options with your doctor, based on the severity of the depression, the nature of your sleep problem, your medical history and susceptibility to side effects, any possible drug interactions, and, of course, your personal preferences.  

Usually, the most important consideration is managing the depression, which should be treated separately with a more effective antidepressant medication, counseling, or both. A separate drug can then be prescribed for the insomnia—either a newer sleep medication or low-dose trazodone. Studies have suggested that trazodone plus another antidepressant can improve sleep in these cases. Alternatively, trazodone might be taken alone, at a higher, antidepressant dose, to treat both problems.

Although trazodone may improve sleep at first, the effect may not continue past several weeks. Taking trazodone may also worsen sleepiness during the daytime, and morning grogginess. Plus, the side effect of sedation may not actually improve depression or insomnia.

Precautions to take

• Because trazodone may not work well to treat insomnia after a few weeks, check in with your doctor periodically to discuss how or if it's still working.
• If you have trouble getting to sleep, take it several hours before you go to bed; if you have trouble staying asleep, take it within 30 minutes before bedtime.
• Avoid trazodone if you're recovering from a heart attack. Inform your doctor if you have abnormal heart rhythms, weakened immunity, active infection, or liver or kidney disease. Use it cautiously if you have heart disease.
• Watch for adverse effects. That's especially important for people over age 55 or so since they're more susceptible to falls caused by dizziness or drowsiness and to abnormal heart rhythms. Close monitoring is also crucial if you're taking trazodone with another antidepressant.
• As with any sleep medication, never mix trazodone with alcohol, and use it cautiously if you're taking other sedating medications or antihypertensive drugs. Ask your doctor or pharmacist about other possible drug interactions.
• If you develop an erection that is unusually prolonged or occurs without stimulation, discontinue the drug and contact your physician. Also call your doctor if you develop fever, sore throat, or other signs of infection while taking trazodone.

Poor sleep habits and how to correct them

 

Watching TV in bed	Don't. TV viewing is not conducive to calming down.
Computer work in bed	Don't work on a computer at all for at least an hour before going to bed.
Drinking alcoholic or caffeinated drinks at night	Don't drink either for at least 3 hours before going to bed.
Taking medicines late at night	Many prescription and nonprescription medicines can delay or disrupt sleep. If you take any on a regular basis, check with your doctor about this.
Big meals late at night	Not ideal especially if you are prone to indigestion or heartburn. Allow at least 3 hours between dinner and going to bed.
Smoking at night	Don't smoke for at least 3 hours before going to bed. (Better yet: quit!)
Lack of exercise	Just do it! Regular exercise promotes healthy sleep.
Exercise late at night	A no-no. Allow at least 4 hours between exercise and going to bed. It revs up your metabolism, making falling asleep harder.
Busy or stressful activities late at night	Another no-no. Stop working or doing strenuous house work at least 2 hours before going to bed. The best preparation for a good night's rest is unwinding and relaxing.
Varying bedtimes	Going to sleep at widely varying bed times -- 10:00 p.m. one night and 1:00 a.m. the next -- disrupts optimal sleep. The best practice is to go to sleep at around the same time every night, even on the weekends
Varying wake-up times	Likewise, the best practice is to wake up around the same time every day (with not more than an hour's difference on the weekends).
Spending too much time in bed, tossing and turning	Solving insomnia by spending too much time in bed is usually counter-productive; you'll become only more frustrated. Don't stay in bed if you are awake, tossing and turning. Get up and do something else until you are ready to go to sleep.
Late day napping	Naps can be wonderful but should not be taken after 3:00 pm. This can disrupt your ability to get to sleep at night.
Poor sleep environment	Noisy, too hot, uncomfortable bed, not dark enough, not the right covers or pillow -- all these can prevent a good night's sleep. Solve these problems if you have them.

Editor's Note: 

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

 

Sharp rise in emergency department visits involving the sleep medication zolpidem

Zolpidem is the active ingredient in Ambien, Ambien CR, Edluar and Zolpimist

A new report shows that the number of emergency department visits involving adverse reactions to the sleep medication zolpidem rose nearly 220 percent from 6,111 visits in 2005 to 19,487 visits in 2010. The Substance Abuse and Mental Health Services Administration (SAMHSA) report also finds that in 2010 patients aged 45 or older represented about three-quarters (74 percent) of all emergency department visits involving adverse reactions to zolpidem.

In 2010 there were a total of 4,916,328 drug-related visits to emergency departments throughout the nation.

From 2005 to 2010 there was a 274 percent increase in the number of female visits to emergency department involving zolpidem (from 3,527 visits in 2005 to 13,130 in 2010) -- in comparison to a 144 percent increase among males during the same period (2,584 visits in 2005 to 6,306 in 2010). In 2010 females accounted for more than two-thirds (68 percent) of all emergency department visits related to zolpidem.

Zolpidem is an FDA-approved medication used for the short-term treatment of insomnia and is the active ingredient in drugs such as Ambien, Ambien CR, Edluar and Zolpimist. These drugs have been used safely and effectively by millions of Americans, however, in January 2013, FDA responded to increasing numbers of reports of adverse reactions by requiring manufacturers of drugs containing Zolpidem to halve the recommended dose for females. FDA also suggested that manufacturers reduce the recommended dose for men as well.

Adverse reactions associated with the medication include daytime drowsiness, dizziness, hallucinations, agitation, sleep-walking and drowsiness while driving. When zolpidem is combined with other substances, the sedative effects of the drug can be dangerously enhanced. This is especially true when zolpidem is combined with certain anti-anxiety medications and narcotic pain relievers which depress the central nervous system. The report finds that in 2010 half of all emergency department visits related to zolpidem involved its use with other drugs. In 37 percent of all emergency department visits involving zolpidem it was used in combination with drugs that depress the central nervous system.

“Although short-term sleeping medications can help patients, it is exceedingly important that they be carefully used and monitored,” said SAMHSA Administrator Pamela S. Hyde. “Physicians and patients need to be aware of the potential adverse reactions associated with any medication, and work closely together to prevent or quickly address any problems that may arise.”

SAMHSA has several major efforts underway to promote prevention and risk reduction regarding prescription drug related problems. For example, SAMHSA ‘s Strategic Prevention Framework - Partnerships for Success II (SPF-PFS II) grant program provides funding to communities throughout the nation for programs raising awareness about the problems of prescription drug misuse and abuse among persons aged 12 to 25. SAMHSA has also partnered with the National Council on Patient Information and Education on the “Not Worth the Risk – Even If It’s Legal” campaign. The partnership has developed and distributed educational and outreach messages to encourage parents to communicate with their teens on prescription drug abuse and misuse. These messages have been distributed to television, radio and newspaper outlets across the nation.

The report entitled, Emergency Department Visits for Adverse Reactions Involving the Insomnia Medication Zolpidem is based on findings from the 2005 to 2010 Drug Abuse Warning Network (DAWN) reports. DAWN is a public health surveillance system that monitors drug-related morbidity and mortality through reports from a network of hospital across the nation.

The complete survey findings are available on the SAMHSA web site at: http://www.samhsa.gov/data/2K13/DAWN79/DAWN79-adverse-reactions-zolpidem.htm


For more information about SAMHSA visit: http://www.samhsa.gov/