A new drug solution for insomnia might require an additional solution to keep users of the drug awake

Having trouble nodding off? Merck has dreamed up a new solution for insomnia.

It’s a drug called suvorexant. It doesn’t have a proper brand name yet. But Merck has high hopes that it will be a major blockbuster.

Suvorexant blocks neurotransmitters that help keep you awake. Simple, right?

Yeah… Just a couple of problems.

Tests show that lower suvorexant doses aren’t very effective. Higher doses work better. But higher doses cause side effects. Like suicidal ideation. And narcolepsy symptoms.

In case you don’t know this, people with narcolepsy often fall into deep sleep during normal daily activities. You know… like driving.

It’s this point that’s causing some anxiety at the FDA. (Don’t worry… I’m sure Merck has something for that, too.)

According to one report, officials are concerned that some suvorexant study subjects “weren’t really able to tell when they were fully awake enough to drive.”

One FDA drug reviewer said, “I think that some patients will drive who shouldn’t be driving and some of those patients will crash.”

Yikes!

The FDA hasn’t approved suvorexant yet. But… surprise, surprise… it looks like they will. Probably at the lower dose. Then it’s up to the savvy insomniacs to bump up the dosage to get it to work.

I’ll let you know if it does get approval and what the official brand name is… so you can avoid taking it and warn your friends.

Hopefully, if it is approved, the FDA will include a black box warning… but not for the box — for the users’ cars!

“Warning: the FDA has deemed that this driver may not be able to tell if he’s fully awake enough to drive. This message sponsored by Merck.”

Sources:
“FDA panel backs low-dose rollout of Merck’s sleep drug suvorexant” John Carroll, Fierce Biotech, 5/22/13, fiercebiotech.com