Showing posts with label adverse reactions. Show all posts
Showing posts with label adverse reactions. Show all posts

Monday, April 25, 2016

Sleep aids carry an array of risks, including next-day hangover effects



Consumer Reports / April 22, 2016


Sleeplessness is complicated — but that hasn’t stopped millions from craving a simple chemical solution. Potions to ease the misery of insufficient sleep can be traced to the ancient Egyptians, who employed an extract of the opium poppy.

In a Consumer Reports survey, 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.

“But those benefits aren’t as great as many people assume, and the drugs have important harms,” says Dr. Lisa Schwartz, 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 pills.

What’s more, the 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.

Even taken as directed, sleeping pills pose risks, including next-day drowsiness. 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 seven or eight hours.

And to address the dangers of next-day drowsiness, the Food and Drug Administration 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 Consumer Reports’ survey found that about a quarter of sleep-aid users drove with less than seven hours of sleep at least once in the previous year.

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 Dr. Ariel Green, 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.

Consumer Reports’ medical experts recommend following these precautions, which apply to both 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 seven or eight 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 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).

Thursday, May 2, 2013

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/