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Wake-Up Call: The Real Dangers of Sleeping Pills

Addiction • Trips to the ER • The Hangover Effect • Minimal Benefit

Experts say sleeping pills work barely better than does a placebo. Furthermore, there’s a lack of clinical evidence in regard to the short-term and long-term dangers.

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Obviously, adequate sleep is essential to your health and well-being, but as many as 1 in 3 Americans don’t get the recommended 7–9 hours of sleep each night, according to Centers for Disease Control and Prevention (CDC).

Contributing to that: 50 million–70 million Americans have a sleep disorder, CDC says. About 10 percent of adults in the United States have chronic insomnia, which interrupts or prevents sleep at least three times per week for 3 months or longer. American Academy of Sleep Medicine (AASM) says 15 percent to 20 percent of U.S. adults have short-term insomnia, which lasts less than 3 months.

Depression, diabetes, heart disease and other serious health conditions are linked to receiving too little sleep, according to CDC’s National Center for Health Statistics (NCHS). A lack of sleep also can be deadly. Drowsy driving causes 328,000 crashes in the United States each year, including 6,400 fatal accidents, according to AAA.

To get more sleep, about 9 million Americans use prescription sleep medications, or sleeping pills, every year, CDC says. Millions more opt to take over-the-counter (OTC) sleeping pills, which make up 84 percent of sleeping-pill sales in the United States, according to Statista, which is a market-research company.

Sleeping-pill sales in the United States are expected to increase to $4.24 billion by 2021 from $3.38 billion in 2016, according to Research and Markets, which is another market-research company.

However, 15 experts tell Consumers Digest that more research is needed to improve the scientific understanding of the dangers of the short-term and long-term use of OTC and prescription sleeping pills. What’s more is that experts tell us that OTC and prescription sleeping pills work barely better than does a placebo.

COUNT SHEEP. Shannon Rhoades Kelly, who is a marketing director, tells us that she relied on sleeping pills in the weeks after her May 2006 heart transplant. Pain and worry kept her awake through the night and sometimes prevented her from getting sleep for days at a time.

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Desperate for rest, she took the prescription sleeping pill Ambien, which is one of the top-selling prescription sleeping pills in the United States. Rhoades Kelly was nervous about taking a sleeping pill in addition to the medication that she took for her transplant, so she occasionally took half of a prescribed 10-milligram dose, which she says helped her to sleep for 6 hours at a stretch. However, even after taking a reduced dose, she says she typically felt “fuzzyheaded” the next morning.

“Everything felt like it was in slow motion,” Rhoades Kelly says.

Rhoades Kelly’s slow-motion feeling is typical. Experts say OTC and prescription sleeping pills frequently produce a “hangover effect” that impairs balance and coordination well into the day after you take the medication.

What isn’t typical is that Rhoades Kelly took Ambien only a few times. Two-thirds of the people who take prescription sleeping pills that contain zolpidem, which is the active ingredient that’s found in Ambien and many other prescription sleeping pills, use and refill their prescriptions multiple times, according to a 2015 report from Institute for Safe Medical Practices (ISMP). AASM and Food and Drug Administration say OTC and prescription sleeping pills should be used only for short-term insomnia, such as during periods of grief or jet lag, and should be taken only for 7–10 days.

Besides the hangover effect, common side effects of taking OTC and prescription sleeping pills include confusion, constipation, dizziness, dry mouth, falls and urination problems. Prescription sleeping pills, which are more powerful than are OTC sleeping pills, because they work by manipulating neurotransmitters (brain chemicals), are linked to an increased risk of death from cancer, cardiac arrest, infection and pneumonia. A 2015 study in American Journal of Public Health concluded that the use of prescription sleeping pills nearly doubled the risk of an automobile crash. Prescription sleeping pills lead to more trips to the emergency room than does any other type of psychiatric medication, experts say.

American Geriatrics Society (AGS) says prescription sleeping pills pose a risk for patients age 65 and older regardless of the duration of their use.

“They should be avoided for any length of time,” says Dr. Nicole Brandt, who is a professor of pharmacy at University of Maryland and a member of the committee of medical experts who develop AGS’s Beers Criteria, which is list of medications that should be avoided by older patients.

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Addiction and dependence also are dangers. People who have a history of alcoholism or substance abuse are at the highest risk to develop a dependence on prescription sleeping pills, says Dr. Raj Dasgupta, who is a pulmonary sleep doctor at University of Southern California (USC).

AASM says doctors and sleep specialists also are concerned about the potential for dangerous interactions between prescription sleeping pills and other medications, in particular prescription pain killers. In a May 2015 report, ISMP noted that 22 percent of consumers who took a sleeping pill that contained the active ingredient zolpidem used it in combination with an opioid painkiller. Thirty percent of opioid-related overdose deaths in the United States involve prescription sleeping pills, according to a 2016 American Academy of Pain Management study.

STILL SLEEPLESS. Almost all OTC sleeping pills, which typically cost $10 for a bottle of 100 pills, are simple antihistamines (think: allergy medication), which make people drowsy.

Mayo Clinic says most people develop a tolerance to antihistamines within a few days. In other words, the effectiveness of OTC sleeping pills quickly diminishes, and users end up taking more of them to try to get to sleep. Their psy- chological dependence on the medication can feel a lot like addiction, Dasgupta says.

Most prescription sleeping pills, which typically cost $17–$60 for a week’s supply, according to American Board of Internal Medicine, make you sleepy by increasing gamma-aminobutyric acid, which is a neurotransmitter that slows brain activity. Belsomra, which is made by Merck and was approved in 2015, is the only sleeping pill that affects a neurotransmitter (orexin) that promotes wakefulness. Hyped by a $96 million advertising campaign as a sleeping pill that “works differently,” Belsomra is on pace to become one of the best-selling sleeping pills of all time. Merck doesn’t claim that it works better or faster than do other sleeping pills, because head-to-head studies haven’t been conducted. Nevertheless, experts say Belsomra will spawn similar medications that affect orexin. (At press time, pharmaceutical company Eisai was conducting clinical trials on a similar medication.)

Experts say all OTC and prescription sleeping pills, regardless of their active ingredients, help people to fall asleep and stay asleep only 10–20 minutes faster than do placebos. Experts also say people who take sleeping pills typically (and incorrectly) conclude that the medication helped them to sleep better than they actually did. That’s because sleeping pills create an amnesic effect, which causes users to forget how much time that they spent being awake after they took the medication.

USC psychiatrist Dr. Daniel F. Kripke, who studied sleeping pills for 40 years and is considered to be one of the most prominent sleeping-pill researchers in the country, says FDA should act to protect consumers from prescription sleeping pills, particularly in regard to the dangers that they pose to elderly users and those who take medications for other health problems. Kripke says recent studies identified health risks that weren’t evident when FDA approved the sleeping pills, so further study is needed.

In 2015, Kripke filed a citizen petition that asked FDA to require pharmaceutical-makers to put stronger warnings on the labels for the most common prescription sleeping pills, so patients and doctors would understand better the risks and the limited scientific understanding of those risks.

“If people could see the warnings, a wise doctor wouldn’t prescribe those pills, and a wise patient wouldn’t take them,” Kripke tells us.

Kripke’s petition also calls on FDA to require sleeping-pill manufacturers to carry out new post-market clinical trials that would establish the risks and the benefits that sleeping pills have. FDA is required by law to order such studies when new research suggests that an approved product has unanticipated dangers, Kripke says.

Kripke updated his petition to FDA in 2016 and in early 2017, so it included new studies that show that sleeping pills contribute to the U.S. prescription-medication “overdose epidemic,” cause infections and “are a pathway to depression and suicide.”

“Almost every month, new information appears about the risks of [sleeping pills],” he says.

Kripke’s concerns aren’t isolated. Dr. Barbara Phillips, who is a sleep researcher at University of Kentucky, called on FDA in support of Kripke’s petition to “immediately limit” the most commonly prescribed sleeping pills. She described most prescribing doctors as being “woefully unaware” of sleeping pills’ risks and possibly more likely to prescribe the medications than they are to discuss the risks with their patients.

University of California, Los Angeles (UCLA) sleep researcher Jerome Siegel, who is a past president of Sleep Research Society and who helped to discover the cause of narcolepsy, also supports Kripke’s petition. He suggests that FDA consider limiting the use of common sleeping pills to “1 or 2 weeks with no refills” or “completely withdraw them from the market.”

An FDA spokesperson tells us that Kripke’s petition “raises complex issues requiring extensive review and analysis,” and the agency will respond after it completes its analysis of the petition. FDA wouldn’t tell us how long that the review process will take nor comment on Kripke’s petition.

In the past 4 years, FDA acted to address the hangover effect of sleeping pills. In 2013, FDA halved the recommended starting dose of Ambien for women and warned users of sleeping pills that contain zolpidem that they shouldn’t drive the day after they take the medication. In 2014, FDA reduced the recommended starting dose for Lunesta.

Kripke worries that FDA will “delay for years” taking action on his petition. He claims that manufacturers know that sleeping pills are dangerous and won’t conduct post-market clinical trials out of fear of what they’ll find. We asked Pharmaceutical Research and Manufacturers of America, which is an industry organization, to respond to Kripke’s call, but the organization declined and said it doesn’t comment on “specific products.”

BACK TO SLEEP. Experts tell us that plenty of evidence exists that cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for chronic and short-term insomnia. CBT-I consists of four to eight treatment sessions that involve in-person therapy and are spaced several weeks apart.

In 2008, AASM recommended CBT-I, rather than sleeping pills, as its first-choice treatment for chronic insomnia. The January 2017 issue of JAMA Psychiatry notes that the principles of CBT-I are “well-tested.”

CBT-I sessions are designed to help patients to change their sleep-related attitudes and behaviors, such as going to bed at the same time every day, avoiding the intake of caffeine after 4 p.m., refraining from eating and exercising shortly before bedtime, and using the bed only for sleep and sex.

At the beginning of the therapy, patients typically feel worse before they feel better, because they have to get out of bed upon waking, so they create a sleep deficit that helps them to fall asleep the next night, says Jennifer Martin, who is a clinical psychologist and a sleep expert at UCLA. A 2015 study that was published in Annals of Internal Medicine found that people who undergo CBT-I fall asleep about 24 minutes faster than do those who take a sleeping-pill placebo, and that they maintained the benefits of therapy long term.

CBT-I falls under mental-health coverage. If you have insurance that covers mental health, your plan should pay for at least some of the cost of CBT-I. The cost can be steep. We found a range of $160–$200 for a 45-minute session.

Unfortunately, experts say the number of therapists who are trained in CBT-I falls short of the demand for it. Experts also say no standards exist for CBT-I, so treatment programs might differ from therapist to therapist. However, technology is expanding patient access. Recent studies suggest that CBT-I that’s in the form of online programs and mobile apps can be effective for people who are comfortable using those media.

Online CBT-I programs cost $45–$135 for weekly sessions that run 5–6 weeks. Sleep experts at Department of Defense developed a CBT-I app that’s available to download for free through the Apple iOS App Store and Android’s Google Play store. Online variations of CBT-I are “promising” in terms of their effectiveness to help users to sleep, according to the January 2017 issue of JAMA Psychiatry. However, experts say more studies are needed for researchers to conclude whether online or app-based CBT-I is as effective as are face-to-face sessions.

Sara Bongiorni is a regular contributor to Consumers Digest. She also has written for The Boston Globe, Christian Science Monitor and the Los Angeles Times.

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