Sleep aids have landed in the safety spotlight recently, with regulatory agencies lowering dosages on some meds to ease side effect worries. But overmedication has its own set of risks, and a new study says those resulted in a doubling of emergency department visits between 2005 and 2010.
Sleep drugs have been the root of plenty of safety worries over the years, especially when it comes to driving while under their influence. Now, just a week after the wrap of one of the highest-profile cases to revolve around Ambien generic zolpidem--Kerry Kennedy's--the European Medicines Agency's Pharmacovigilance Risk Assessment Committee is recommending updates to its product information to underscore the drug's associated risks.
As more and more sleep drugs hit the market, the customer pool is expanding, too. New data from the CDC says prescriptions for sleep drugs have tripled over the last 20 years--with older people recording the highest rate of use.
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