FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep

SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

The agency announced Wednesday the approval of Intermezzo (zolpidem tartrate) sublingual tablets, made by Port Richmond, Calif.-based Transcept Pharmaceuticals. The drug contains the same active ingredient as Sanofi's Ambien but at a lower dose. Zolpidem already has lost patent protection, allowing other companies not only to make generic versions of it, but also to develop "branded generics" that are novel formulations of it, as Transcept has done.

"For people whose insomnia causes them to wake in the 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," FDA Center for Drug Evaluation and Research deputy center director Robert Temple said. "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."

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