The Medical Letter on Drugs and Therapeutics
Subscribers: Log in to read full issue.  Not a subscriber?  Subscribe or purchase issue.
FDA Requires Lower Dosing of Zolpidem

On January 10, 2013, the FDA issued a news release to announce that it was requiring the manufacturers of the zolpidem-containing products Ambien, Ambien CR, Edluar and Zolpimist, which are all approved for treatment of insomnia, to lower the doses for women and to recommend in their labeling consideration of a lower dose for men.1 No change will be required in the dose of Intermezzo, a low-dose sublingual formulation of zolpidem for middle-of-the-night awakening, which is already recommended in a lower dose for women.2

New Data – Driving simulation and laboratory studies recently submitted to the agency indicate that zolpidem serum concentrations >50 ng/mL can seriously impair driving performance. In pharmacokinetic studies, 8 hours after taking 10 mg of Ambien, 15% of women and 3% of men had ... more      

The Medical Letter is a subscriber-funded nonprofit organization that publishes critical appraisals of new prescription drugs and comparative reviews of drugs for common diseases.

Would you like to read the rest of this issue?  Gain access below.

Subscriptions to The Medical Letter on Drugs and Therapeutics include:
  • Print version published and mailed biweekly (26 issues/year)
  • Unlimited online access to current and past issues (1988 - present)
  • Mobile App for iOS, Android, and Kindle Fire
  • FREE online per issue CME/CE
Purchase this issue:
Title: Issue 1408
 Downloadable, electronic issue - $45

Gain access through your organization
Ask your librarian to consider an Institutional Subscription to The Medical Letter.
Recommend to your librarian