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Transcept's night-waking cure gets FDA nod

(Reuters) A first-of-its-kind drug for patients who face difficulty in going back to sleep after abruptly waking up in the middle of the night is expected to hit market next year, with the U.S. approval Wednesday of Transcept Pharmaceuticals' Intermezzo…
Intermezzo, chemically known as zolpidem tartrate sublingual, is a lower dose formulation of zolpidem tartrate that was approved by FDA in 1992 as Sanofi's widely-used sleeping pill Ambien.
The drug has to be placed under the tongue to let it disintegrate completely before swallowing, and is designed to be taken only in the middle of the night.
Patients must have at least four hours of bedtime remaining after its intake, Transcept said in a statement.
"You only take it when you actually need it," [Transcept Chief Executive Glenn] Oclassen said.
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