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FDA Issues New Warnings About Effects of Common Sleep Drugs

FDA Issues New Warnings About Effects of Common Sleep Drugs
May 11
20:55 2019

There have been hundreds of news reports about the importance of getting a full night’s sleep. For adults, it has been recommended that regular sleep runs no less than 7 hours and no more than 9 hours. For teenagers the recommendation, at least from many reports, runs about 1-2 hours more than adults.

A number of health problems has been associated with the lack of the sleep. Those issues include type 2 diabetes, heart related issues, obesity and even cognitive functions.

With all the warnings, there are many people who continue to stay up late and get up early. Many others just have problems sleeping through the night – I’m one of these.

About 20 years ago, my doctor recommended a couple of sleep medications, one of which was Ambien. It helped for a short time, perhaps a few weeks, but after that, all it did was make me groggy when I first woke up.

When that didn’t work, he sent me to the sleep clinic at the local hospital where they discovered that I have 3 separate and distinct sleep disorders. The bad news was, that to treat the worst of the three (sleep apnea) it would most likely aggravate the other 2 and if he treated the other two, it would make the sleep apnea worse. Consequently, for the past 15 years, I sleep with a C-pap machine. It helps, but on a good night of laying down for 8 hours, I’m lucky to get 4-5 hours of total sleep. However, after the first good sleep that lasts about an hour and a half to two hours, the rest of the night I sleep in 10-15-minute increments or less, leaving me tired all day long. The only time I get a really good night’s sleep of close to 7 hours, is when I’m either really sick or the first few nights after getting acupuncture.

Millions of Americans rely on sleep drugs such as Ambien and Lunesta to help them get a good night’s sleep. Both of these sleep aids come with warnings of side effects such as being careful driving or operating heavy equipment, but most people generally ignore these warnings and do whatever they want. Some will wake up, get dressed and take right off to work, not realizing that they still could be under the effects of their sleep medication.

This has prompted the FDA to issue a new warning about the using sleep medications, as reported:

“The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.”

“As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.”

The FDA report goes on to explain the reasoning behind the new warnings:

“Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.”

“Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.”

buy pfizer brand viagra online purchase zithromax for chlamydia “Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death. Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior.”

“Patients should stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine.”

“We identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death (see Data Summary). This number includes only reports submitted to FDA or those found in the medical literature,…”

If you take one of these sleep medications, follow the FDA warning above and see your doctor to make sure you are taking the right medication and not becoming addicted to it. Best to be safe than sorry.

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