Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)
January 16, 2013
FDA has recommended labeling changes to lower the bedtime dose of zolpidem. This recommendation applies to all zolpidem products, generic and brand name products including Ambien, Ambien CR, Edluar, and Zolpimist. New information suggests mental alertness may be impaired the next morning due to high blood concentrations. Females eliminate zolpidem from the body more slowly than males and may be at greater risk of impairment. Also, patients taking extended-release zolpidem products may be at higher risk for reduced mental alertness the morning after taking a dose.
The new dosing recommendations are summarized below. The new recommendations do not include Intermezzo, which is a zolpidem-containing sublingual tablet approved to treat middle-of-the-night awakenings. The labeling for this product recommends a zolpidem dosage of 1.75 mg for women and 3.5 mg for men.
New dosing recommendations for zolpidem-containing products except Intermezzo
- Decrease dose from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist)
- Decrease dose from 12.5 mg to 6.25 mg for extended-release products (Ambien CR)
- Consider prescribing 5 mg for immediate-release products and 6.25 mg for extended-release products
Healthcare providers should prescribe the lowest dose of all sleep medications to treat sleep problems. Counsel patients that they may experience decreased impairment from all sleep medications even if they feel fully alert.
Zolpidem is a sedative-hypnotic used to treat insomnia and carries warnings about the risk of drowsiness when taking this medication. FDA has been monitoring the safety profile of this medication since its approval and continues to assess the risk of taking zolpidem. Additionally, FDA is monitoring and evaluating other insomnia medications for reduced mental-alertness the morning after an administered dose.
Patients should talk to their healthcare provider before making any dosing changes. Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
Additional information is available at the following links:
- MedWatch Alert:
- FDA News Release
- FDA Questions and Answers
- FDA Drug Safety Communication
- FDA Consumer Update
January 16, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.