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.
As Bloomberg reports, the CDC's National Center for Health Statistics looked at sleep-drug use from 2005 to 2010. The findings? About 4% of U.S. adults reported recently using a sleep aid, while 7% of those age 80 and older reported the same use. And more women than men reported using the medications.
But despite the growth in prescription numbers, the sleep-drug business is tough. Sales volume is shrinking, thanks to new generics, and more pharma players are jumping into the field.
They're battling in an overcrowded market. The expiration of Sanofi's ($SNY) Ambien patent opened the floodgates for generics, and newly approved sleep drugs have struggled. After plowing $100 million into an ad campaign for its new drug Intermezzo to little result, Purdue Pharma last year kicked in another $29 million for direct-to-consumer advertising and deployed hundreds of sales reps to detail the drug. Purdue's initial ad push was the biggest since 2005, when another sleep med, Lunesta, got a $100 million budget with a $320 million follow-up the year after.
Yet companies still see an opportunity. Current sleeping pills don't work for everyone, and even when they do, benefits can be marginal, leaving room in the market for new offerings. Merck ($MRK), for one, has high hopes for its blockbuster candidate suvorexant, which the company has repeatedly touted as a top pipeline prospect. Unlike competitors Lunesta and Ambien, suvorexant blocks a neurotransmitter responsible for keeping the body alert, making it less likely to interfere with a person's memory or attention, researchers have said. An FDA panel recently backed a low dose of the drug.
Sleep drugs come with their fair share of safety concerns. The FDA has blamed some sleep aids for car accidents caused by still-sleepy drivers and has been cautious about approving new ones for that very reason. In January, the agency required makers of Ambien and its relatives containing the API zolpidem to halve recommended doses for women. Then, in May, Merck met with FDA worries about suvorexant. Its expert panelists voted against higher doses of the drug--despite the fact that the higher doses proved more effective--because of safety concerns.
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