FDA approves Transcept Pharma's Intermezzo mid-night insomnia treatment

US drugmaker Transcept Pharmaceuticals (Nasdaq: TSPT) saw its shares jump 11% to $7.34 yesterday, after it said that the Food and Drug Administration has approved Intermezzo (zolpidem tartrate sublingual tablet) C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than four hours of bedtime remaining before the planned time of waking. This is the first time the FDA has approved a drug for this condition.

The news follows an earlier delay in the approval of Intermezzo, as the FDA issued a complete response letter on the drug’s re-submitted New Drug Application (The Pharma Letter July 15), with the agency stating that it could conclude that Intermezzo can be used safely based on the information in the NDA.