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sleep aid 6 articles

New sleeping pill gets FDA approval, awaits DEA clearance

A new type of prescription sleep aid has won approval from the Food and Drug Administration (FDA) and if given clearance from the Drug Enforcement Administration (DEA) should be commercially available later this year. Belsomra, made by Merck & Co., works by temporarily blocking chemicals in the brain that control sleep cycle and keep people awake at night. The sleeping pill is designed to help people with insomnia to sleep through the night. Belsomra was approved based on trials that pitted the medication against a placebo. It was not tested against other sleep aids, however, so it is not known ... Read More

Sleeping pills, anti-anxiety drugs send more people to the ER

Bad reactions to anti-anxiety medications and sedatives send more people to the emergency room than any other drugs, according to a new study published in JAMA Psychiatry. The findings come from an analysis of medical records from 63 hospitals from 2009 to 2011. Researchers noted that most of the ER visits involved adverse side effects or overdoses, and nearly 20 percent of those resulted in hospitalizations. The biggest problem-maker was the sedative zolpidem tartrate, the active ingredient in the brand-name sleep aid Ambien. The drug is available in other brands as well as in generic. The drug accounted for nearly ... Read More

FDA warns of next-day impairment with sleep aid Lunesta

The insomnia drug Lunesta (eszopiclone) can linger in users’ bloodstreams hours longer than intended, causing impairment of driving and other activities that require alertness, the Food and Drug Administration warned. The agency is recommending that starting doses be lowered to 1 mg at bedtime for both men and women. The drug labels for Lunesta and its generic counterparts will be updated to reflect the new warnings and recommended dosing. The new dosing is based on a study that found that the previously recommended dose of 3 mg can cause impairment of driving skills, memory and coordination that can last more ... Read More

FDA rejects experimental sleeping pill for people with insomnia

A first drug in a new class of insomnia treatments was rejected by the Food and Drug Administration (FDA) because the agency said safety data didn’t support approval of the treatment at the dosing proposed. The drug, called suvorexant, made by Merck & Co., was under review by the FDA in both 30- and 40-milligram doses. The FDA advised Merck that suvorexant was effective at doses as low as 10 milligrams up to 40 milligrams, with 10 milligrams seen as the starting point. As a result, the FDA advised that Merck seek approval for the lowest dosage before it grants ... Read More

FDA requires lower recommended dosage for insomnia drug Ambien

Many people who take the prescription sleep aid Ambien at bedtime still have high levels of the drug in their systems the morning after, which affects their alertness and impairs their ability to drive vehicles, the Food and Drug Administration (FDA) announced this week. The agency is requiring that the recommended dosage be lowered to reduce this risk. Ambien and Ambien CR, which contain the active ingredient zolpidem, are sold both in brand name and in generic versions. Zolpidem is also the drug used in the sleep aids Ediuar, Zolpimist and Intermezzo. The FDA issued a safety communication that also ... Read More

Experimental sleep aid helped test patients fall asleep faster, stay asleep longer

An experimental new drug to help insomniacs fall asleep faster and stay asleep longer is showing good results in clinical trials. Suvorexant, made by Merck, is a new type of sleep aid that works differently from others currently on the market. Suvorexant works by targeting and blocking chemical messengers known as orexins that are designed to keep you awake and alert. They originate in the hypothalamus, a major sleep center in the brain. The new drug was tested during a three-month period in two separate trials of more than 1,000 people who suffer from insomnia. Patients in the first trial ... Read More