The U.S. Food and Drug Administration (FDA) has approved a new sleeping pill called Belsomra made by Merck & Co.
The new drug will help people with insomnia, who cannot sleep or have difficulty staying asleep. The FDA explains that Orexin is a neurotransmitter in the brain that keeps an individual awake. Belsomra changes the orexin signaling in the brain, which assists a person in sleeping properly.
Sleep is considered an important element of public health. According to the U.S. Centers for Disease Control and Prevention (CDC), insufficient sleep can lead to diseases like hypertension, obesity, diabetes, depression as well as cancer. Moreover, insufficient sleep can cause industrial errors, as well as motor accidents if the driver falls asleep unintentionally.
Merck & Co. suggests that the latest Belsomra has lesser side effects than current sleeping pills. Belsomra will be available in four strengths: 5, 10, 15 and 20 milligrams.
"Today's approval of BELSOMRA allows for the introduction of a new treatment option for patients suffering from insomnia," says Dr. David Michelson, vice president, Neurosciences, Merck Research Laboratories. "BELSOMRA is the result of more than a decade of Merck research in neuroscience and provides tangible evidence of our long-standing commitment to innovation."
FDA says that using the lowest strength of the sleeping pill can reduce side effects such as next-day drowsiness. The FDA recommends that the new Belsomra sleeping pill should only be taken once per night and within 30 minutes of going to bed. The government agency also recommends that a person should take Belsomra with at least 7 hours remaining to wake up. The maximum dosage of Belsomra should not exceed 20 milligrams in a day.
The FDA points out that the common side-effect reported by participants of clinical trial was drowsiness. The highest dosage of the sleeping pill may also cause drowsiness the next day, which can impair driving ability that requires alertness in a person. The FDA suggests that people who take the maximum dosage of Belsomra may be impaired even if they feel totally awake.
The new sleeping pill is estimated to generate $305 million in sales by 2017 and Merck & Co. hopes to get a green signal from the U.S. Drug Enforcement Administration (DEA). Once the DEA makes its final decision, the sleeping pill may be commercially available by late 2014 and early 2015.
