Suvorexant (Now Branded As Belsomra®) Clears FDA -- Good News For Whitehouse Station -- But Still Highly Likely To Be A Schedule IV Controlled Substance

The line quoted below -- in navy blue -- may sound like a punch line -- "while having sex. . ." but that is exactly the kind of thing Merck will be concerned about. Suvorexant has -- as many Schedule IV drugs do -- the real potential to be abused (even as a would be date rape drug). So, I'd not expect Belsomra^® to become a higher level multi billion dollar a year drug. Not likely. [Valentine's Day 2014 backgrounder, here.] Schedule IV drugs are kept under extraordinary security (beyond the usual lock and key), at pharmacies and in hospitals, and are subject to rigorous record keeping and evidentiary trails -- while in transit. Makes really deep -- and wide -- dispensing a little less likely.

In addition, the US Drug Enforcement Administration has not finally decided that suvorexant will be Schedule IV, though it seems highly likely. In any event, Merck cannot begin to sell the drug in the US until the DEA announces its final decision. From the FDA presser of this afternoon, then -- a bit:

. . . .Like other sleep medicines, there is a risk from Belsomra of sleep-driving and other complex behaviors while not being fully awake, such as preparing and eating food, making phone calls, or having sex. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy. Patients or their families should call the prescribing health care professional if this type of activity occurs.

Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance (Schedule-IV) because it can be abused or lead to dependence. . . .

Really?! While having sex?!

I really couldn't make this stuff up, even if I tried. I promise -- I couldn't. And I don't mean to make light of a potentially life altering experience. At a minimum, Merck may be sued for unwanted pregnancies -- where the allegation will be that he -- or she -- (or both!) didn't fully realize they were engaging in baby making behavior. "The Belsomra did it!"