NAPSR News: FDA Approves Merck’s BELSOMRA® To Treat Insomnia

Merck specializes in developing new therapies that treat and prevent diseases to help people in need around the world.
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WASHINGTON - Aug. 14, 2014 - PRLog -- The FDA has approved BELSOMRA® (suvorexant) developed by Merck & Co to treat insomnia in adults. The drug’s therapeutic effect is that of a highly selective antagonist for orexin receptors. Orexin is a neurotransmitter that regulates wakefulness and arousal.

FDA approval was based on the results of clinical trials involving 500 participants assessing sleep latency and sleep maintenance both objectively by polysomnography and subjectively by patient-estimated sleep latency. The administration of BELSOMRA®  produced superior results compared to the placebo. The suggested dosage of the drug is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of waking and the dosage amount should not exceed 20mg once daily, according to the company.

“Today’s approval of BELSOMRA allows for the introduction of a new treatment option for patients suffering from insomnia,” said 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."

The FDA has proposed a Schedule IV drug classification by the U.S. Drug Enforcement Administration (DEA) under the Controlled Substances Act.  A decision has to be made by the DEA on the prescribing restrictions before the drug hits the market.  Pending the DEA’s decision, once launched the drug is estimated to generate $305 million in sales by 2017, according to the analysts’ estimates compiled by Bloomberg,

The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community.

The CNPR® Program represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Pharmaceutical sales candidates who have this training will differentiate themselves from other individuals looking for open positions. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. CNPR® graduates should immediately utilize the NAPSRx® Career Center to apply for pharmaceutical sales positions.

Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(NAPSRx) for more information or visit the website at

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