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November 27, 2011

FDA approves Intermezzo sublingual tablet for insomnia

The US Food and Drug Administration (FDA) has approved Transcept Pharmaceuticals' Intermezzo (zolpidem tartrate) C-IV, used to treat insomnia.

The US Food and Drug Administration (FDA) has approved Transcept Pharmaceuticals’ Intermezzo (zolpidem tartrate) C-IV, used to treat insomnia.

Intermezzo is available in doses of 1.75mg and 3.5mg as a sublingual tablet that contains a bicarbonate-carbonate buffer.

Women are recommended to take the 1.75mg dosage, while the 3.5mg is intended for men, as because women clear zolpidem from the body at a slower rate, the company said.

The approval is backed by two placebo-controlled studies which evaluated the safety and efficacy of Intermezzo for the treatment of patients with insomnia.

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