FDA doesn't require labeling changes for Intermezzo in review of sleep aids

theflyonthewall.com

The FDA announced earlier that it is requiring Sanofi (SNY), the manufacturer of Ambien, and some makers of other insomnia drugs that contain zolpidem, to lower the recommended dose. The FDA said the recommended bedtime dose should be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. The FDA said recommended doses of Transcept Pharmaceuticals' (TSPT) Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men, the FDA noted. In afternoon trading, shares of Transcept rose 16c, or 3.04%, to $5.43.

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