An exploration of sleep and insomnia, with a single destination in mind:
a good night's sleep.

Monday, December 28, 2015

Belsomra Report Card: Meh

By Ken Mallows

            Readers of this blog know that we're not particular fans of sleep drugs. We're not against the occasional use of prescription medicine for sleeplessness, but the science shows that continual use of sleeping pills may do more harm than good. Plus, they really don't solve your sleep issues; they mask them.
            We think that natural remedies and techniques are best in the long run.
            We're always willing to have our minds changed – we believe in modern medicine – but such is not the case with a relatively new drug known as Belsomra from drug maker Merck. Belsomra is a new type of sleep medicine called an orexin receptor. The chemical name is suvorexant. Most sleeping pills increase GABA a neurotransmitter that slow brain activity so you can nod off.  Belsomra decreases the neurotransmitter Orexin which keeps you up.
            Merck's TV commercials have been a big hit, using an odd (and to me, scary looking) plush creature that is supposed to show the drug gently purring you to sleep. Belsomra has been around a little over the year and doctors wrote 4,000 prescriptions when it first hit pharmacy shelves. It may turn out to be the best selling insomnia medication ever which is saying something because the FDA estimates that docs handed out more than 42 million sleep aids scripts in the U.S. in 2014.
            So what's the problem?
            Clinical tests show that Belsomra may really not work any better than Lunesta and Ambien, which both have their own problems. According to  Dr. Gregg Jacobs, an insomnia specialist at the Sleep Disorders Center at the UMass Memorial Medical Center: "At the 20 mg dose [the highest] that was approved by the FDA, people ... only obtained an extra 16 minutes of sleep. This is meaningless clinically." Participants also only fell asleep an average of six minutes faster than those who took a placebo.
            Consumer Reports also weighed in and commissioned two drug safety experts—Steven Woloshin, M.D., and Lisa M. Schwartz, M.D., both at the Geisel School of Medicine at Dartmouth—to review the research about Belsomra. Schwartz served on an FDA advisory committee of experts that looked at Belsomra in 2013. According to their analysis "people who took a 15 mg or 20 mg dose of Belsomra every night for 3 months fell asleep just 6 minutes faster on average than those who got a placebo pill. And the Belsomra group slept only 16 minutes longer—6 hours and 12 minutes total vs. 5 hours and 56 minutes for the placebo group, Consumer Reports reported.
            Like other pills such as Ambien and Lunesta, users also reported being drowsy the next day not to mention a drop in memory and other cognitive functions. Other tests of the Belsomra showed that it worked about the same as a placebo and that cognitive behavior therapy worked better than all drugs. In fact, CBT works on about 80 percent of those with insomnia. Studies also show other tricks like relaxation, cutting back on blue light before bedtime, exercise and cutting back on caffeine all help to give you a good night's sleep.

            Belsomra's success in the marketplace cannot be denied, however, but it speaks more to advertising and patient pleas to their doctors just to get the good night's sleep that they so dearly want and need – and will do most anything to achieve. 

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