FDA staffers found clear evidence to prove that Merck's blockbuster drug candidate suvorexant is quite effective in promoting sleep, but the internal review cites multiple safety issues for the high doses studied in clinical trials.
What's one of FDA's biggest worries about sleeping-pill safety? Auto accidents caused by still-sleepy drivers.
The regulatory road to the FDA is littered with the burned wreckage of once-promising sleep drug programs. Merck, though, is making an ambitious bid to change the entire game on sleep drugs.
Ambien's sleep-driving side effect is back in the news: Kerry Kennedy told cops on the scene of her DUI arrest that she'd taken the sleep aid, sold by Sanofi and several generics makers.
Merck unveiled a full slate of Phase III data on its experimental sleep drug suvorexant, claiming a success in safely promoting a good night's rest among patients suffering from insomnia. And the pharma giant's team leader on the project says the late-stage results pave the way for an NDA later this year on one of the biggest late-stage drug prospects in its pipeline.
The DTC juggernaut is weakening. As The New York Times reports, industry spending on TV ads fell by 2% in 2011, the fourth consecutive year of decline. Altogether, TV spending is down 20% from 2007...
Popular sleep drugs such as Ambien can leave even the healthiest older people groggy and prone to stumbling, falling and confusion when they wake up, U.S. researchers reported. Report
No question psychiatric drugs are widely used, but Forbes quantifies that today--and tells us just which drugs ride the highest. Psych drugs were prescribed 250 million times last year, according to
An animal study is shedding new light on the complicated chemistry of the brain, and how a drug intended to do one thing can have entirely unintended consequences. Researchers at Georgetown
A new study in mice may help explain some of the rare but strange side effects in people taking the Sanofi-Aventis sleep drug Ambien, including sleep walking, midnight binges and driving while not