New sleep med isn't worth the risk
There's a new sleep drug on the market -- but if you think it's safer or better than what's out there now, all I can say is: Keep dreaming.
This drug suvorexant (to be marketed as Belsomra) is so risky that the FDA actually rejected it last year.
Now, the second time around, the agency approved it -- but the drug didn't get any better over the past year. They didn't go back to the drawing board and improve it.
No, the drug hasn't changed at all. All that's changed is the dose.
Last year, the agency looked at doses of 20 mg and 40 mg and found that patients were so loopy they had difficulty driving, not hours after taking it but the next day.
So the company that makes the drug ditched the 40 mg dose and got Belsomra approved at doses of 5, 10, 15 and 20 mg instead. But even at lower doses, the drug can cause impairment problems so severe that the FDA is urging patients who take 20 mg to avoid driving or doing anything else that requires mental alertness the next day.
I don't know about you, but I think we all need to be mentally alert each day, whether we're driving or not.
And the risks don't end there.
Some patients who took the drug in clinical trials reported suicidal thoughts or behaviors, versus none reported in the placebo groups.
One person who took the drug in a study reported waking up and being unable to move -- as if someone was holding her down. She said she had the sensation of someone else being in bed with her... but there was no one there.
And this was at the now-approved dose of 20 mg.
The FDA said it's also concerned about unconscious nighttime activity -- people who get up and do things, like eating or even going out, all while still technically asleep.
Sounds to me like this could be a life-changing drug in all the wrong ways.
But you don't have to face big risks to get a good night's sleep. All you need is a new approach -- one that focuses on finding and correcting the cause of your sleep problems.
It's not as hard as it sounds.
I have everything you need to get started in this free report from my House Calls archives.