FDA Issues New Warning Label Requirement for Sleeping Pills

Yesterday the FDA issued a request to makers of sedative-hypnotic drug products, asking them to strengthen warning labels regarding potential risks including severe allergic reaction and face swelling and "complex sleep-related behaviors." The FDA says the latter may include sleep-driving and making phone calls and preparing/eating food while asleep. The prescription sleep drugs involved are: Ambien [CR] (Sanofi), Butisol Sodium (Medpointe Pharm), Carbrital (Parke-Davis), Dalmane (Valeant Pharma), Doral (Questcor Pharma), Halcion (Pharmacia & Upjohn), Lunesta (Sepracor), Placidyl and Prosom (Abbott), Restoril (Tyco), Rozerem (Takeda), Seconal (Lilly) and Sonata (King Pharma). The NY Times cites data from Verispan showing Sanofi-Aventis' Ambien CR was the most prescribed sleep aid in the U.S. last year at 27.6 million of 44m prescriptions filled, followed by Tyco Healthcare's Restoril and a generic, temazepam, with 7.3m, and Sepracor's Lunesta with 5.8m. Shares of Sanofi and Abbott Labs both lost 0.6% to $41.90 and $53.77, respectively yesterday, while Sepracor fell 0.9% to $48.38, Lilly lost 0.3% to $51.90, King Pharma gained 1.3% to $18.64 and Valeant Pharma rose 1.7% to $17.43.

Sources: FDA press release, Associated Press, Reuters, The New York Times, The Wall Street Journal
Commentary: King Pharmaceuticals: A Healthy Way to Recover from the Selloff • Biotech Day in Review: Lilly Buys Insomnia-Focused Hypnion
Stocks/ETFs to watch: Sanofi-Aventis (SNY), Tyco Int'l (TYC), Sepracor (SEPR), Abbott Labs (ABT), Eli Lilly (LLY), King Pharma. (KG), Valeant Pharma. Int'l (VRX), Questcor Pharma. (QSX), Takeda Pharma. (JP:4502). ETFs: iShares S&P Global Healthcare (IXJ), Pharmaceutical HOLDRs (PPH), Health Care Select Sector SPDR (XLV)
Related: NY Times podcast [mp3]

Seeking Alpha's news briefs are combined into a pre-market summary called Wall Street Breakfast. Get Wall Street Breakfast by email -- it's free and takes only seconds to sign up.