Nov. 23, 2011 -- Insomniacs wide awake in the wee hours now have a get-back-to-sleep pill -- Intermezzo.
The FDA approved the pill on Wednesday. Designed by Transcept Pharmaceuticals for people who wake in the middle of the night, the drug is a fast-acting, low-dose form of zolpidem (best known as Ambien at its higher bedtime dose).
Citing safety concerns, the FDA had twice previously refused to approve Intermezzo. The FDA had one main worry: that people might get up and try to drive before the drug fully wears off. Studies clearly show that the drug badly impairs driving, and that this effect lasts longer in some people than in others.
Responding to FDA concerns, Transcept changed the Intermezzo label to state that the drug should only be taken when people have at least four hours of sleep time remaining. And the label tells people not to drive for at least one hour after waking and at least five hours after taking Intermezzo.
Moreover, people should not take Intermezzo if they've been drinking alcohol or if they've taken other sleep aids.
Waking During the Night
"For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," Robert Temple, MD, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research. "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."
Men clear zolpidem from their systems about twice as fast as women do. Transcept therefore offers Intermezzo in two dosages: a 3.5-milligram dose for men and a 1.75-milligram dose for women, taken only once per night.
Zolpidem in its full-dose, taken-at-bedtime form is best known as Ambien, made by Sanofi-Aventis. It's also available as a generic drug. Other forms of zolpidem include an under-the-tongue tablet (Edluar), a spray mist (Zolpimist), and an extended-release pill (Ambien CR).
Intermezzo, like other sleeping pills, can cause serious side effects. These include getting out of bed not fully awake and being unaware of doing things or remembering you did them.
Activities reported to the FDA while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking. Alcohol or other sleep medicines increase the risk of doing such things.
Like Edluar, Intermezzo is an under-the-tongue tablet designed for quick release. But Intermezzo contains only a quarter to a third as much zolpidem. And it is the only form approved for middle-of-the-night use.
And like other forms of zolpidem, Intermezzo is a controlled substance that can be abused or that can lead to drug dependence.