Ambien and Ambien CR Warning Labels Expanded
August 19, 2016 – The FDA is requiring warnings on the labels of Ambien® (zolpidem) and Ambien CR® (zolpidem extended-release) tablets to highlight their potential association with psychomotor (conscious input into movement) problems. The manufacturer, Sanofi, must clearly explain in the labeling the possibility that residual effects, such as dizziness, drowsiness, slowed response time and vision changes may interfere with driving and other tasks on the day following Ambien use. To reduce risks, patients taking either product to treat insomnia should allow at least seven hours for sleep after taking Ambien or Ambien CR. Doses should not be repeated during the night and patients should not take doses that are higher than recommended amounts. Additionally, patients should avoid taking certain other drugs (including some antidepressants and antifungal agents) and drinking alcohol while they are using Ambien or Ambien CR.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.