This new med is so dangerous, even those who don’t take it are at risk

The drug that can kill you even if you don’t take a single pill

Things just got a lot more dangerous out there.

I’m talking about on the road — and even on the sidewalk.

And we have the FDA to thank.

It just gave the green light for a new kind of sleeping pill. One that is guaranteed to have a lot more people going right through lights, stop signs, and swerving all over the road.

And that warning about “next-day driving impairment”? Well, it comes directly from the FDA.

“I think that some patients will drive who shouldn’t be driving and some of those patients will crash.” That’s what an FDA reviewer had to say about this new sleeping pill called Belsomra.

The FDA was especially concerned about “psychomotor impairment.” That’s a fancy way to say someone isn’t fit to do anything that requires much thinking — or coordination.

And people under the influence of Belsomra won’t even know that they’re not fit to drive.

Now that little problem had the FDA really worried.

So what did the agency do about it? Why, of course — it approved Belsomra. The reason: it helped people fall asleep faster than a placebo!

Did you catch that?

Belsomra wasn’t even tested against other drugs on the market.

And because of that, the FDA admits it doesn’t know if Belsomra might be even more dangerous than other sleeping drugs already out there.

But it did give this warning: Anyone taking the 20 mg dose should be “cautioned” against driving the next day. Or doing anything else that requires “full mental alertness.”

Give me a break! How many people are going to listen to that — especially if they have to drive to work?

And if you’re taking a lower dose — even the very lowest one there is — you may drive just as dangerously. The FDA says that’s because it doesn’t know how the drug will affect different people.

Now that we know how dangerous that 20 mg dose is, we’re very lucky that Merck’s first stab at getting Belsomra approved didn’t work.

That was last year, when the FDA said “No” to what the drug company really wanted — a 40 mg pill! But it said that dose was way too dangerous to okay.

Now Belsomra works in a “special” new way. It’s so new and so special that no one knows exactly what the real-world effects of taking this drug might be.

It’s called an “orexin receptor antagonist.” It works by blocking a newly discovered brain chemical called orexin that researchers believe play a part in keeping us awake and alert.

But it’s obvious that we really don’t understand exactly what happens when orexin is interfered with.

Here’s what some people who took Belsomra reported:

A 58 year-old woman said that she had a dream that “something dark approached her.” When she woke up several times during the night, she was paralyzed and couldn’t speak. Later, she awoke standing in front of a window with no idea how she got there.

Others, ranging from 20-somethings to people in their late 60s, also had nightmares, heard screams in their sleep and were unable to move or speak.

People in the Belsomra study also had trouble staying awake while driving. One woman, who was taking the lower 20 mg dose fell asleep at the wheel and “drove across the middle line with her eyes closed.”

And besides sleep driving, sleeping drugs like this one can also cause sleep eating, sleep cooking, and even having sex — while still sleeping. The FDA advises calling your doctor if any of that happens to you (if you know about it, that is!).

Now considering all the risks involved with Belsomra, you would think at least people who take it would be sleeping better — that is sleeping in bed at night, not behind the wheel of a car.

But they didn’t. Belsomra didn’t even add much to total sleep time.

So if you’re having trouble falling asleep at night, there are many things you can do that will help — and won’t have you sleep-driving!

One good way is to up your melatonin levels. You can do that easily with a melatonin supplement, or with foods high in it, such as cherries and bananas.

Sources:
“FDA approves new type of sleep drug, Belsomra” August 13, 2014, FDA press release, fda.gov

“Merck wins FDA nod for a weaker form of its embattled sleep drug” Damian Garde, August 13, 2014, FierceBiotech, fiercebiotech.com