Pharmaceutical

New sleeping pill gets FDA approval, awaits DEA clearance

sleep 435x334 New sleeping pill gets FDA approval, awaits DEA clearanceA 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 whether the drug is safer or more effective than currently available sleeping pills.

The FDA approved four different doses of Belsomra, but said lower doses of the drug would cause fewer side effects, which include next-day drowsiness. The FDA recommends that Belsomra be taken only once per night within 30 minutes of going to bed, and users should allow at least seven hours for sleep. The maximum dosage should not exceed 20 milligrams in one day.

Common side effects associated with Belsomra include next-day drowsiness, which can cause impaired driving. Those who take the maximum dosage may still be impaired even if they feel totally awake.

The approval of a new sleeping pill comes just months after the FDA lowered the recommended dosages of Ambien, Lunesta and related sleep aids based on studies that linked the medications to next-day impairment that led to driving problems, and loss of memory and coordination.

If given DEA clearance, Merck & Co. would be required to collect post marketing safety data on Belsomra to observe potential adverse effects.

Sources:
PharmPro
Tech Times