It sounds like from the seeking alpha article we are going to need the following for the middle of the night:

1)driving safety study conducted -- didn't sound like it was too enormous of a study required;

2)Design the bottle such that only one dose (and not more) can be taken accidently. This may really be the rub. Query if priming is needed? That makes it harder to design something it think. Ideally you would put some lock mechanism that after one press you have to move the lock again. I really doubt NVD has thought this through and designed something in the bottle beyond just your typical spray bottle. i have seen no patents. If they can't work out some design fix to the bottle..it would seem Zolp..middle of the night could be tuff to get FDA approval with just warning labels.