Content about insomnia treatment

October 4, 2011
Insomnia treatment under consideration for Rx-to-OTC switch

Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

SAN DIEGO — Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

January 31, 2011
Transcept announces PDUFA action date for Intermezzo

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

August 29, 2010
Somaxon, P&G to co-promote Silenor

A drug maker and a consumer packaged goods company will co-promote a newly approved insomnia...

SAN DIEGO A drug maker and a consumer packaged goods company will co-promote a newly approved insomnia treatment.

Somaxon Pharmaceuticals and Procter & Gamble announced their co-promotion agreement for Silenor, in which Somaxon's promotion of the drug will target physicans, while P&G will promote Silenor to targeted pharmacies.