Federal health regulators say they have approved the first insomnia pill designed for people who wake up in the middle of the night and have trouble getting back to sleep.
Transcept Pharmaceuticals' Intermezzo pill is a lower dose of the key ingredient in Ambien, the popular sleep medication first approved in 1992. FDA officials say the new pill offers a safer option than taking a second dose of zolpidem tartrate, the ingredient in Sanofi's Ambien, to get back to sleep.
"With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving," said Dr. Robert Temple, director for clinical science in FDA's drug center.
The FDA's approval for Intermezzo follows two previous rejections 2009 and again in July 2011 due to safety issues. The FDA's concerns centered on the drug's potential side effects the following day, including potential impact on driving.
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The FDA said in a statement Intermezzo should only be used when patients have at least four more hours to sleep. The pill will come in a 1.75-milligram dose for women and a 3.5-milligram dose for men. The dose for women is lower because the drug clears the body at a slower rate in women than in men.
Intermezzo was studied in two studies involving more than 370 patients. Patients taking the drug fell back to sleep more quickly than those taking a placebo, or sugar pill.
Shares of Point Richmond, Calif.-based Transcept Pharmaceuticals rose 8 cents to $6.69 in afternoon trading.
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