Is it possible to be killed by a med you're not even taking? In this case, yes!

Even if you steer clear of this drug, it can still ‘steer’ right into you

There are millions of people who take this drug every night. And if they get behind the wheel of a car the next morning, you’d better buckle up and watch out.

That’s because they may not be awake enough to drive — or even walk.

The FDA has known about this little problem for some time. It calls it “psychomotor impairment.” That’s a fancy way to say someone isn’t fit to do anything that requires much thinking — or coordination.

But it’s much worse than just being a little tipsy.

Because many have no idea that they’re in no shape to drive.

Now, after 10 years of people taking this drug, and many of them “sleep- driving” the following day, the FDA has finally stumbled into action in hopes of keeping us safer on the roads.

A wake-up call

The Lunesta Web site says that you’ll “fall asleep and stay asleep so you can wake up feeling rested.”

So rested, in fact, that you might still be sleeping. Only you won’t know it.

And now, after a decade of that green Lunesta moth flitting into people’s bedrooms at night, the FDA suddenly came out and said that it’s worried about that “next-day impairment” issue. So worried, in fact, that it’s going to officially cut the starting dose in half (and in some cases, by two-thirds) — down to 1 mg.

So what took it so long to come to this decision? We know the FDA works pretty slowly — when it works at all — but come on now, 10 years?

And it wasn’t as if they didn’t know about this “sleep driving” issue from the get-go, either.

The FDA said its new half-dose decision was made “in part,” because of a study of 91 adults who took a 3 mg-dose of Lunesta and had “severe next-morning” memory impairment. It said “driving skills,” as well as “memory and coordination” didn’t come back to normal even as long as 11 hours after the drug was taken!

But with over 31 million prescriptions flying off Rx pads for this drug since 2004, how did a study of 91 people manage to suddenly change the dose?

Well, there’s another little fact about Lunesta that didn’t get much attention.

It looks like the FDA’s decision was timed just right to help the drug’s maker, Sunovion Pharmaceuticals, squeeze every last dollar they could out of the drug.

The drug company managed to wrangle extensions for its patent — giving it exclusive rights to Lunesta sales — right up until May 31. That was just two weeks after the FDA’s announced dose change.

That’s money in Sunovion’s pocket. Big money, considering Lunesta made them well over $800 million last year. And those sales weren’t tainted by any announcements from the FDA about taking a lower dose so you don’t start driving in your sleep.

But even though Sunovion won’t be earning those big bucks after the end of May on Lunesta sales, it doesn’t mean the drug is going away — or that you’ll be any safer on the highway.

Because that’s when the generic versions will flood the pharmacy — and at a cheaper cost. So now, even more people might be taking it.

And driving around with no idea of what they’re doing.

The FDA says that it’s continuing “to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs” and will be letting us know as soon as new information is available.

Thanks FDA! I’ll figure we’ll be hearing back from you on this right after the 2024 Olympics.

Sources:
“FDA requiring lower starting dose for sleep drug Lunesta” FDA press release, May 15, 2014, fda.gov

“SUNOVION PHARMACEUTICALS RECEIVES SIX MONTH U.S. PEDIATRIC EXCLUSIVITY FOR LUNESTA® (eszopiclone)” Sunovion press release, July 26, 2012, ds-pharma.com