Last year we told you about a newly approved sleeping pill, called Belsomra (Suvorexant). When the American Food and Drug Administration (FDA) approved Belsomra late last year, the agency was especially concerned about one of its side effects: “psychomotor impairment ” – a fancy way to say someone isn’t fit to do anything that requires much thinking or coordination.
As a result, Belsomra was let loose on the market with a warning about “next-day driving impairment”… meaning Belsomra is guaranteed to have a lot more people going right through red traffic lights, stop signs, and swerving all over the road.
Let sleeping dogs lie
If you think the risks of Belsomra end with a few unruly swerves across the road, think again. In fact the side effects of this drug are terrifying.
I’m talking about depression, suicidal thoughts, problems breathing, sleep paralysis, and even a disturbing condition called cataplexy – a sudden loss of muscle function that can happen if you get too happy or even angry. Laugh too hard and your legs can give out, triggering a dangerous fall or even a bone break.
But the really big problem with Belsomra, the one Merck is trying desperately to sweep under the carpet and hide in the fine print of the drug’s information leaflet, is how easy it is to kill yourself and others when taking this drug.
Yes, you guessed it, it’s the side effect I mentioned earlier: psychomotor impairment.
Belsomra’s clinical trials found that psychomotor impairment was the most common side effect. And it is so serious that an FDA reviewer who studied the drug said: “I think that some patients will drive who shouldn’t be driving and some of those patients will crash.”
To make matters a little bit worse, people under the influence of Belsomra won’t even know that they’re not fit to drive ?¦ and that little problem had the FDA really worried.
And if you’re taking a lower dose you may still drive just as dangerously. That’s because the FDA says it doesn’t know how the drug will affect different people.
However, in true FDA-style, the agency went straight ahead and approved Belsomra. Their reason: it helped people fall asleep faster than a placebo!
That’s because Belsomra wasn’t even tested against other sleeping drugs on the market, which is why the FDA admits it doesn’t know if Belsomra might be even more dangerous than other sleeping drugs already out there.
It seems that Belsomra is so new and so ‘special’ that no one knows exactly what the real-world effects of taking this drug might be.
What we do know is this: Belsomra is an “orexin receptor antagonist.” It works by blocking a newly discovered brain chemical called orexin that researchers believe plays a part in keeping us awake and alert.
Frankly, the only thing the FDA is clear about is this warning: Anyone taking the recommended 20mg dose should be “cautioned” against driving the next day. Or doing anything else that requires “full mental alertness.”
We’ll add another warning to Belsomra: Don’t take this drug.
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“Merck ramps up Belsomra marketing, hoping to wake up a sleepy insomnia market” Beth Snyder Bulik, June 13, 2015, FiercePharma, fiercepharmamarketing.com
“Merck’s quest to revive the market for insomnia drugs” Arlene Weintraub, June 4, 2015, Forbes, forbes.com