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Why the Best Insomnia Treatment Is Not A Drug

Consumer Reports Best Buy Drugs compares the effectiveness and safety of the most common treatments

Last updated: May 2017

At-A-Glance

Everyone has trouble sleeping from time to time—stressful life events like having to take a test the next day, or dealing with worries about home or work can keep you from falling asleep or staying asleep. Sleeping problems that happen once or twice a month can be annoying, but usually will resolve on their own.

But when sleep problems are ongoing and cause you distress—occurring several nights a week for three months or more—it’s time to see your doctor. It could be a more serious matter and may be chronic insomnia (though your doctor may call it “insomnia disorder”). Up to 10 percent of adult Americans suffer from this problem, and it’s not something to be ignored.

Besides making you feel lousy, not getting enough sleep over the long term has been associated with other problems: it puts you at a higher risk for type 2 diabetes and heart disease. It can also decrease cognitive function, and lower your productivity at work.

Insomnia might also leave you feeling anxious, sad, or irritable, and it’s been linked to a worsening of symptoms for people with depression and anxiety. Getting treatment is important to improving sleep and may help with other health conditions.

Frequently, doctors have relied on sleep medications like eszopiclone (Lunesta and generic); ramelteon (Rozerem and generic); zaleplon (Sonata and generic); zolpidem (Ambien, Ambien CR, Edluar, ZolpiMist, and generic); or other drugs like the antidepressant trazodone, to manage insomnia.

In fact, previous CR Best Buy Drug reports looked closely at the differences among these medications—how much faster did they help people get to sleep? Which ones helped people sleep longer during the night? The answers to those questions, along with considerations about the safety and side effect profile of each drug and its cost, had guided our earlier reports and selection of a “Best Buy” among these drugs.

New Research Changes Our Recommendations

But three important changes have since occurred. First, the recognition among clinicians that while sleep drugs might provide some benefit in the short term, their modest benefits may not outweigh their risk over the long term.

Our past reports on these treatments have found that the newer sedative medications add only between 8 to 20 minutes of sleep time, and none have been shown to improve how well people feel or perform the next day. And, they can also cause troubling side effects: next-day drowsiness, dizziness, and feeling unsteady—all of which can increase your risk of falls or accidents.

Sleeping pills can also cause dependency and even worsen the symptoms of chronic insomnia if taken for long periods. Sleep-walking, memory lapses, and hallucinations are rare, but have been reported with Ambien, as have cases of driving or eating while asleep within a few hours of taking a sleeping pill. Plus, most of these medications have only been tested over short time periods and in highly select patients. So, little is known about their long-term safety and effectiveness, especially in older individuals, those with serious medical conditions, or with less severe sleep problems.

Second, the release of a recent systematic review of insomnia treatments—drug treatments, behavioral therapy, and alternative therapies—by the federal Agency for Healthcare Research and Quality (AHRQ)—found strong scientific evidence that shows cognitive behavioral therapy (CBT) for insomnia is a consistently effective way to treat the problem.

It works like this: a provider is trained to help teach you better sleep habits, develop regular sleep cycles, and suggest ways to change your behavior, using techniques such as sleep restriction and controlling stimulus, while also working to change the way you think about sleep.

The report found CBT to be effective for most adults with chronic insomnia, and safer because there are few, if any, side effects. CBT might also potentially keep insomnia at bay longer than medication—even after the therapy ends.

Several medical groups, including the American Academy of Sleep Medicine and the American College of Physicians, have suggested that when chronic insomnia is diagnosed, to try CBT first, instead of sleep medication alone. (Some people may benefit from both, however.)

The AHRQ report also evaluated other types of medications—an older kind called benzodiazepines, sedative sleep drugs like zolpidem (Ambien and generic), and several antidepressants that can cause drowsiness as a side effect. The report found good evidence that when used for short periods the sedative drugs are effective at helping people fall asleep and stay asleep a bit longer.

Overall, across some 14 studies, from 50 percent to 85 percent of people diagnosed with chronic insomnia, as well as those who have not, get some benefit from the drugs, compared to 19 percent to 48 percent of people who took a placebo instead of the active drug.

However, the report found insufficient evidence that the benzodiazepine drugs, when compared to placebos, were helpful in combating insomnia. In addition, few studies adequately assessed the side effects the drugs can cause.

The third shift in recent thinking derives from growing evidence that far too many people take sleep medicines for long periods—months or even years—leading to a kind of psychological addiction that can be both medically counterproductive and dangerous.

That's why our Best Buy pick isn’t a drug at all. 

For chronic insomnia, CR Best Buy Drugs recommends that you first try cognitive behavioral therapy. According to the evidence, even a single session can help, but best practice is to have at least four. Sessions done in a group setting or even online can also be effective. That doesn’t mean you should always avoid medication. Insomnia drugs can be helpful in the short term, and your doctor might recommend you take one for a brief period.

What Causes Insomnia?

Occasional problems with sleeping can arise spontaneously but can be triggered by a change in sleeping patterns or habits. For example, travel—jet lag and sleeping in different beds and locations—is a common cause.

Not being able to get to sleep or stay asleep can often be related to other symptoms like pain, hot flashes from menopause, frequent urination from bladder or prostate problems, fibromyalgia, heartburn from gastroesophageal reflux disease (GERD), heartburn, or conditions such as asthma, bladder fibromyalgia, sleep apnea, hyperthyroidism, Parkinson’s or Alzheimer’s disease.

Most notably, depression and anxiety are well-established sleep disruptors—and the more profound your symptoms of these are, the worse your insomnia may be.

In all these cases, successfully treating the underlying condition usually helps a person sleep better. That’s particularly true of heartburn, pain, and anxiety.

Some medicines also interfere with sleep. These include allergy and cold medications, beta-blockers, certain pain relievers, steroids, and asthma drugs. Indulging in alcohol or caffeinated beverages at night can disrupt sleep and is often a habit doctors and sleep specialists target right away.

How To Correct Poor Sleep Habits

Habit

Strategy to fix it

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. Light emitted from computers, mobile devices, and smart phones (so called “blue light”) signals daylight to the brain even more than ordinary light bulbs and has been shown in studies to delay falling asleep.

Drinking alcoholic or caffeinated drinks at night

Alcohol often leads to sleep disruption later in the night and may contribute to awakenings. Consume caffeine in moderation and not after midday.

Taking medicine late at night

Many prescription and nonprescription medicine 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

Stop working or doing strenuous housework at least 2 hours before going to bed. The best preparation for a good night’s rest is unwinding and relaxing.  

Varying bedtimes and wake-up times

Going to sleep at widely varying times–10 p.m. one night and 1 a.m. the next, for example–disrupts optimal sleep. Go to sleep about the same time every night, even on the weekends and wake up about 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

Don’t stay in bed if you are awake, tossing and turning. Get up and do something else relaxing, such as reading, until you are ready to go to sleep.  

Late-day napping

Naps can be wonderful but should not be taken after 3 p.m. because they can disrupt your ability to get to sleep at night. If you have sleeping problems, it may be best to avoid napping altogether.  

Poor sleep environment

Noise, a room that’s too hot or not dark enough, an uncomfortable bed, covers, or pillow–all can prevent a good night’s sleep. Solve those problems if you have them.  

Don’t Rely on Drugstore Products

One of the most common over-the-counter sleep aids is the antihistamine diphenhydramine, also used to treat seasonal allergies (found in Benadryl Allergy, for example). This decades-old drug blocks the histamine receptors in your brain that also control wakefulness—so drowsiness is a side effect for some people.

Diphenhydramine is found in dozens of products on drugstore shelves, including, Advil PM, Nytol, Simply Sleep, Sominex, Tylenol PM, Unisom SleepMinis, or ZzzQuil, from the makers of NyQuil. Other OTC sleep products may contain a similar drug, doxylamine.

These products advertise that they can help you with a night or two of insomnia—the instruction labels say not to exceed taking them for longer than two weeks. But the problem is that some people can develop a dependence on them.

In fact, a 2015 Consumer Reports national survey of 4,023 adults found that of the 20 percent who took an OTC medication within the past year to improve sleep, almost 1 in 5 respondents, or 18 percent, said they took it on a daily basis. Most concerning: 41 percent told us they used the drugs for a year or longer.

That's a problem because diphenhydramine can cause constipation, confusion, dizziness, and next-day drowsiness, according to the drug’s FDA labeling. Another concern is the “hangover effect”—impaired balance, coordination, and driving performance the day after you’ve taken the drug, heightening the risk for falls and accidents. And in a January 2015 study in JAMA Internal Medicine, the frequent, long-term use of first-generation antihistamines, including diphenhydramine, was linked to an increased risk of dementia, including Alzheimer’s disease.

If you find you are turning to these medications beyond a two-week period as per their package instructions, it’s time to see a doctor because you may have chronic insomnia, and there’s a better and safer way to treat it.

Relief Without Medication

One nondrug approach—cognitive behavioral therapy (CBT) for insomnia—has been show to be effective in treating chronic insomnia, according to a recent large-scale, systematic review by the Agency for Heath Research and Quality, and published in the Annals of Internal Medicine.

Two medical groups—the American Academy of Sleep Medicine and the American College of Physicians—recommend it as a first-choice treatment for people who suffer from chronic insomnia.

Although there are variations of CBT, it usually involves undergoing a sleep assessment, followed by working with a therapist (usually a psychologist or clinical social worker, or possibly a doctor) to foster healthy beliefs about sleep (called “cognitive retraining”) and develop better behaviors and routines around sleep.

For example, you might be prohibited from watching TV in bed, be coached to get up at the same time every day, or taught relaxation or meditation techniques. You may be asked to keep a sleep diary. The idea is that through guided behavioral change and cognitive conditioning, you can improve your sleep and reduce or eliminate your insomnia.

How CBT Works

CBT for insomnia usually involves three to six, one-hour sessions with a trained therapist, plus directions for at-home activities. Ideally, your therapist will coordinate with other clinicians you are seeing, including your primary-care doctor. If your insomnia has been triggered by a life event or by depression or anxiety, you will likely be referred to a counselor or psychotherapist.

This approach helps between 70 to 80 percent of people with chronic insomnia—shortening the time people fall asleep by 12 to 40 minutes, and adding 20 to 45 minutes of total sleep time.

And, the benefits of CBT for insomnia are longer-lasting than medication, and continue even after your CBT ends. While formal research comparisons between CBT for insomnia and sleeping pills are inconclusive, many experts, including treatment guidelines from the American Academy of Sleep Medicine and the American College of Physicians, suggest CBT is a better path to permanent relief from chronic insomnia than long-term use of any kind of sleeping pill—primarily because it deals with the underlying triggers of insomnia. And, there is little downside or risk of side effects.

Indeed, CBT is not restricted to people with chronic insomnia. Some sleep specialists and clinics now use it to treat people who have intermittent bouts of insomnia as well. A study published in JAMA Internal Medicine in September 2015 involving an analysis of 37 studies of 2,189 people found that CBT for insomnia was also effective in those with co-existing illnesses and psychiatric conditions, included alcohol dependence, depression, post-traumatic stress disorder, cancer, chronic pain, and fibromyalgia.

If you see a primary-care provider or therapist for chronic insomnia and they first prescribe pills without mentioning cognitive behavioral therapy for insomnia as an option, you should bring it up. If they don’t know anything about it, find a provider who does.

Sedative Drugs

We evaluated five prescription sleeping pills. They are:

Generic Name(s)

Brand Name(s)

Available as a Generic?

Eszopiclone

Lunesta

Yes

Ramelteon

Rozerem

Yes

Suvorexant Belsomra No

Zaleplon

Sonata

Yes

Zolpidem

Ambien

Yes

Ambien CR

Yes

Edluar (dissolvable tablet)

No

Zolpimist (oral spray) No
Intermezzo (low dose dissolvable tablet) No

Three of these newer sleeping medicines—eszopiclone, zaleplon, and zolpidem—work the same way, by affecting a chemical in the brain called GABA.

Among them, zolpidem has been available in the U.S. the longest (since 1992); generic versions have been available since 2007. Only eszopiclone is currently approved for longer-term use. Ramelteon works differently: It affects the receptor in the brain for the hormone melatonin. Suvorexant, the newest prescription sleep medicine, works by affecting a group of chemicals in the brain that regulate the sleep-wake cycle.

How They Compare

All the newer sedative drugs have been shown to help people fall asleep faster—but only by a marginal amount.

First, it’s important to note that the placebo effect is fairly strong in studies that tested the sedative drugs. People who took a placebo (or sugar pill) got to sleep, on average about 20 minutes faster than they otherwise would. People who took a drug got to sleep, on average, 10 to 20 minutes faster than those who took placebo (so about 30-40 minutes faster overall).

The range varies widely, depending on the severity of a person’s insomnia and sensitivity to the drug’s effect.

Zolpidem (Ambien and generic) and zaleplon (Sonata and generic) tend to act more quickly in the body and thus appear more effective at helping you fall asleep.

In one study that directly compared the two drugs in the same group of patients, Sonata was slightly better than zolpidem—by about 17 minutes on average—in bringing sleep about. Other studies, however, have consistently found zolpidem better than Sonata at producing longer duration sleep. Also, people taking zolpidem have reported “better quality” sleep than those taking Sonata.

Eszopiclone, zolpidem, and suvorexant may improve short-term global and sleep outcomes for adults with chronic insomnia, but the comparative effectiveness and long-term efficacy of drug therapy for insomnia are not known. Plus, drug treatments may cause cognitive and behavioral changes and may be associated with infrequent but serious harms.

Most of the clinical trials were done in small groups of people, and did not last beyond a few weeks. That makes it difficult to generalize the trial findings to large populations and to know anything about taking the medication for a longer period.

Side Effects

All of the sedative drugs drugs can cause side effects in adults and do so at about the same rate. None of these drugs offer an advantage over another in that regard.

Two of the most common are headaches and dizziness, and in some cases an unpleasant taste. Less common is something called “rebound” insomnia, especially for suvorexant and zolpidem. Only about 2 to 6 percent of people in these studies stop using the drugs because of these problems.

Sedative drugs cause more side effects in older people. And, studies have shown that these medications increase the risk of hip fracture in older people, too, because they can lead to accidents and falls.
 
Other side effects include:

Next-day drowsiness: A 2015 Consumer Reports survey of 4,023 people found that 36 percent said they were drowsy the next day after taking any sleep drug.


Previous Best Buy Drug reports have shown that Ambien CR causes more next-day drowsiness than the other drugs. Belsomra 20 mg caused impaired next-day driving performance in some men and women, but it is not clear how the frequency of next-day drowsiness compares with that of the other newer drugs.

Driving risks: Several sleeping-pill directions caution users to take the medications only if they can stay in bed for at least 7 to 8 hours. And, partially to address the dangers of next-day drowsiness, the FDA has cut in half the recommended doses for Ambien and Lunesta for women and older people. The labels for Ambien CR and Belsomra 20 milligrams, specifically, warns users not to drive at all the day after taking the pill, until you are accustomed to taking the drug.

 

The same Consumer Reports survey found that about a quarter of people who use any sleep-aid said they drove with less than 7 hours of sleep at least once in the previous year. Four percent admitted they dozed off while driving.

 

A study of nearly 410,000 adults published August 2015 in the American Journal of Public Health found that people prescribed sleeping pills were almost twice as likely to be in car crashes as other people who had not taken a sleeping pill.

 

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.

Rebound insomnia: Occurred in some people taking zolpidem, Ambien CR, and Lunesta, but not Sonata, Rozerem, or Belsomra. But the problem is usually short-term.

Dependence: There have been reports of dependence and associated abuse with zolpidem, and most have occurred among people who had problems with drug or alcohol dependence in the past. Because they work differently, Rozerem and Belsomra are not considered to have the potential for dependence and abuse that the other new insomnia medicines have.

Sleep-walking, amnesia, and hallucinations are rare. However, reports of these problems should be a warning that excessive use or when taken with alcohol or an especially excessive dose in the middle of the night can all raise the risk of serious problems.

Other Sedating Drugs

Benzodiazepines

These drugs came into public awareness in the early 1960s when diazepam (Valium and generic), was prescribed for “restless” housewives. The benzodiazepines also include such drugs as alprazolam (Xanax and generic) and lorazepam (Ativan and generic). These three are prescribed primarily to treat anxiety.

But the FDA has approved five benzodiazepines to treat insomnia: estazolam (generic only), flurazepam (Dalmane and generic), quazepam (Doral), temazepam (Restoril and generic), and triazolam (Halcion and generic). These may be used if a person has an anxiety disorder or their insomnia is linked to a recent life trauma that has led to anxiety and/or emotional distress.

Benzodiazepines carry serious risks, especially if taken for long periods.

Several studies indicate that benzodiazepines cause more day-after sleepiness, confusion, and grogginess, and are associated with a significantly higher risk of dependency and rebound insomnia (when the insomnia returns after the person stops taking the medication) than the newer insomnia drugs.

But few well-designed studies have directly compared the newer insomnia drugs with benzodiazepines, and many researchers think it’s unclear whether the newer sedative drugs are more effective or safer.

Trazodone

Although no longer used to treat depression, an older antidepressant called trazodone (generic only) has a side effect of causing drowsiness. As a result, it is widely prescribed for insomnia—especially for people who have been diagnosed with both depression and insomnia. Some doctors prescribe it for people who have insomnia, but are not diagnosed with depression as well, although it is not FDA-approved for this use.
 
For short-term use, studies indicate it helps people with depression fall asleep and stay asleep. But there is little evidence as yet that it is effective in treating insomnia in people who have not been diagnosed with depression or in those with chronic insomnia. In the one study conducted with non-depressed people, trazodone came out only slightly better than a placebo but was not as helpful as zolpidem (Ambien). Very little is known about its long-term risks.

What's Behind Our Recommendations

Our evaluation is primarily based on an independent scientific review of the evidence on the effectiveness, safety, and adverse effects of the newer sleeping pills and non-drug insomia treatments. A team of physicians and researchers at the Minnesota Evidence-Based Practice Center conducted the analysis for the Agency for Healthcare Research & Quality Effective Healthcare Program. They reviewed 181 unique studies of treatments for insomnia published in or before January, 2015.


A synopsis of AHRQ’s analysis of the insomnia drugs forms the basis for this report. The synopsis was based on AHRQ’s analysis as well as a search for recent trials, systematic reviews, and FDA information. The findings were subsequently used by the American College of Physicians to develop treatment recommendations for patients with insomnia disorder. A consultant to Consumer Reports Best Buy Drugs has experience with the Evidence-based Practice Program and has no financial interest in any pharmaceutical company or product.


References to earlier 2012 CR Best Buy Drugs report on insomnia treatments was based on a an earlier analysis developed by the Drug Effectiveness Review Project, or DERP. DERP is a first-of-its-kind multi-state initiative to evaluate the comparative effectiveness and safety of hundreds of prescription drugs. It was previously conducted by a team of physicians and researchers at Oregon Health & Science University Evidence-Based Practice Center. A synopsis of DERP’s analysis of the insomnia drugs forms the basis for our previous 2014 report.


References

Brasure M, MacDonald R, Fuchs E, Olson CM, Carlyle M, Khawaja IS, Diem S, Koffel E, Ouellette J, Butler M, Kane RL, Wilt TJ. Management of Insomnia Disorder. Comparative Effectiveness Review No. 159. AHRQ Publication No.  15(16)-EHC027-1-EF. Rockville, MD: Agency for Healthcare Research and Quality. December 2015.
https://www.effectivehealthcare.ahrq.gov/ehc/products/548/2164/Insomnia-executive-151230.pdf

Buscemi N., et al, “Manifestations and management of chronic insomnia in adults. Evidence report/technology assessment No. 125. Rockville, MD: Prepared by the University of Alberta Evidence-based Practice Center; 2005.

Buscemi N, Vandermeer B, Friesen C, et al. The Efficacy and Safety of Drug Treatments for Chronic Insomnia in Adults: A Meta-analysis of RCTs. J Gen Intern Med. 2007;22(9):1335-1350. doi:10.1007/s11606-007-0251-z.

Carson S, McDonagh M, Thakurta S, Yen P. Drug class review: Insomnia. 2008.  http://www.ncbi.nlm.nih.gov/books/NBK47207/  Accessed May 30, 2015.

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FDA. Statistical review of eszopiclone. http://www.fda.gov/cder/foi/nda/2004/021476_Lunesta_statr.PDF.

FDA. Statistical review of ramelteon. http://www.fda.gov/cder/foi/nda/2005/021782s000_Rozerem_statr.pdf.

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Liu J, Wang L -n. Ramelteon in the treatment of chronic insomnia: systematic review and meta-analysis: Ramelteon for chronic insomnia. Int J Clin Pract. 2012;66(9):867-873. doi:10.1111/j.1742-1241.2012.02987.x.

Mendelson, W.B., A review of the evidence for the efficacy and safety of trazodone in insomnia,” J. Clin. Psychiatry (April 2005): 66 (4) 469-476.

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Editor's Note:

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



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