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.

Pharmaceutical Technology Excellence Awards - Have you nominated?

Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact. This is your chance to showcase your achievements, highlight industry advancements, and gain global recognition. Don't miss the opportunity to be honoured among the best - submit your nomination today!

Nominate Now