Last year Americans spent $2 billion on sleep drugs, a big drop from the $3.6 billion recorded by IMS Health back in 2006. The reason for the plunge is simple: Longtime standard treatments like Ambien have gone generic. And some of the most prominent developers in the business--companies like GlaxoSmithKline and Sanofi--have abandoned experimental sleep drug programs after hitting a snag.
Regulators can be as tough on sleep drug applications as they are on obesity treatments, a lesson that Transcept learned the hard way after the FDA rejected its generic form of Ambien last week, citing safety concerns over the prospect of lingering amounts of the drug in drivers as they slid behind the wheel. One of the most recent sleep drugs to be approved, Somaxon's Silenor, has earned only meager revenue. But none of that has stopped Merck and a few of its rivals from developing new sleep drugs that target a novel set of mechanisms.
An in-depth article the Wall Street Journal takes a close look at Merck's late-stage orexin inhibitor, hoping to blunt a chemical that triggers alertness. In a Phase IIb study, the Journal notes, researchers said that side effects included drowsiness, vivid dreams and occasional dizziness. Neurim Pharmaceuticals, meanwhile, is angling for FDA approval of a prescription strength dose of melatonin, which helps people nod off.
One reason why sleep drugs haven't performed better is that many physicians like to stick with simple strategies like sticking with a healthy sleeping schedule, avoiding late-night sessions with the TV or computer and shunning caffeine when it's likely to keep you up. When regulators have risk-free alternatives to a potentially unsafe treatment, the safety bar always rises to a high level.
- here's the WSJ story