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11/22/2024 08:47:56 am

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New Insomnia Pill, Belsomra, Approved by the FDA

Sleep

(Photo : Reuters)

Insomniacs might never have to lose sleep over losing sleep again.

The U.S. Food and Drug Administration has just approved a new sleeping drug, Belsomra (suvorexant), developed by the pharmaceutical company, Merck & Co.

David Michelson, head of neurosciences at Merck Research Laboratories, said the FDA approval "allows for the introduction of a new treatment option for patients suffering from insomnia."

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Belsomra works by turning off wakefulness rather than by inducing sleep.

The ingredients in Belsomra temporarily block orexins, chemicals that regulate sleep cycles and cause people to have trouble sleeping at night.

Insomnia, which ranges from mild to severe, is a condition where an individual has trouble falling or staying asleep. The sleep condition can leave a person anxious, depressed and irritable. Along with these side effects, insomnia can also affect a person's cognitive functions.

The FDA approved Belsomra in four different doses for varying degrees of insomnia. Doses available are 5, 10, 15 and 20 milligrams.

The highest dosage for the drug is 20 milligrams. The dosage has caused users of the drug to feel groggy and have difficulty functioning in the morning.

Because of this, physicians have warned patients not to take the high dosage if they have to drive the next day or undertake in activities that require concentration.

"Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness," said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research.

Only one tablet per night should be taken, within a half hour before bedtime. Belsomra will be sold with a patient medication guide that notes how the pill should be taken.

The drug is considered a controlled substance because its usage may lead to abuse or dependence.

Merck stated that the recommended dose for Belsomra is 10 milligrams. The drug will be available by late 2014 or early 2015.

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