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news.The US Food and Drug Administration (FDA) has issued approval for Transcept Pharmaceuticals' Intermezzo (zolpidem tartrate sublingual tablet) C-IV, used to treat insomnia.
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Intermezzo is available in doses of 1.75 mg and 3.5 mg as a sublingual tablet that contains a bicarbonate-carbonate buffer.
The approval is backed by two placebo-controlled studies which evaluated the safety and efficacy of Intermezzo for the treatment of patients with insomnia.
Transcept, along with Purdue will develop and commercialise Intermezzo in the US.