Merck & Co. Offers New Sleep Aid: Insomnia Still Prevalent

Merck & Co.

Merck & Co.’s new sleep aid, Belsomra (suvorexant), offers an additional sleep aid option for the sleepless, yet insomnia is still prevalent in the United States, plaguing approximately 30 percent of adults, according to the National Institutes of Health (NIH). While pharmaceutical sleep aids are designed to provide a much-needed quick fix to the problem of insomnia, some drugs may carry side effects that ultimately defeat the purpose for which they were originally taken.

Insomnia is defined by the NIH as difficulty falling asleep, staying asleep or receiving nonrestorative sleep, despite an adequate opportunity for sleep. Before prescribing a sleeping pill for anyone suffering from insomnia, a diligent physician will ensure that a person’s difficulty sleeping has resulted in daytime distress more than three times a week for at least one month.

Belsomra works differently from other popular sleeping pills. Orexins are chemicals that help regulate the sleep-wake cycle. By altering the way orexins signal the brain to stimulate wakefulness, Belsomra allows a person to fall asleep and stay asleep more easily. Other popular sleep aids, such as Sanofi’s Ambien (zolpidem tartrate) and Sumitomo Dainippon Pharma Co.’s Lunesta (eszopiclone), which both work by calming the central nervous system. Belsomra’s novel mode of action may allow it to be prescribed for people who are unable to tolerate central nervous system depressants.

Belsomra, like all pharmaceutical drugs, carries side effects. One especially noteworthy side effect of suvorexant is next-day drowsiness. Both Merck & Co. and the Food & Drug Administration (FDA) have noted that Belsomra’s next-day drowsiness effect is significant enough to impair driving as well as other activities requiring concentration, especially at higher doses. Individual variation in the intensity of a drug’s effects can be expected, and it is important to note that certain individuals, especially women, may retain the effects of certain drugs in their bodies for a long time. Belsomra may generate $305 million in sales for Merck & Co. in 2017, according to industry analysts’ estimates.

Further studies are ongoing, and despite Merck & Co.’s new sleep aid offering, insomnia is still prevalent. While the FDA’s Aug. 13, 2014, approval of Belsomra moves the new sleep aid one step closer to market, the drug must still undergo Drug Enforcement Agency (DEA) approval to determine prescribing restrictions. Belsomra is expected to be available by prescription in early 2015.

Meanwhile, individuals who suffer from insomnia may benefit from non-pharmaceutical sleep aids. The National Center for Complementary and Alternative Medicine (NCCAM) recommends implementing lifestyle change as a first-line approach to counteracting insomnia. Strategies for lifestyle changes that can alleviate insomnia include setting a consistent bedtime, eliminating electronic stimulation in the bedroom, blocking excess light in the sleeping area, eating a balanced diet and exercising regularly.

While many herbal remedies are available for alleviating insomnia, the NCCAM states on its website that the agency cannot recommend them because “the evidence for other complementary approaches is either inconsistent or too limited to draw conclusions” about their effectiveness. Individuals interested in trying herbal or holistic sleep aids are advised to do their own research, use common sense, and consult with their health care providers before trying anything new.

NCCAM admits, however, that sufficient scientific evidence does in fact support relaxation techniques and the dietary supplement, melatonin, for alleviating insomnia. Relaxation techniques such as yoga, tai chi, and mindfulness meditation relax the mind and body. Melatonin is a hormone that helps regulate the sleep-wake cycle and is available as a dietary supplement.

While the prevalence of insomnia continues to grow, new sleep aids such as Belsomra, from Merck & Co., will continue to find an appropriate niche in the marketplace. Consumers who still value a good night’s sleep will work with their doctors to choose the sleep aid that work best for them.

By Lane Therrell

Sources:

FDA
NIH
NCCAM (Sleep Disorders)
NCCAM (Sleep Disorders and Complementary Health Approaches: What You Need To Know
ABC News
Bloomberg

Your Thoughts?