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Wake-Up Call: The Real Dangers of Sleeping Pills (cont.)

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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.”

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