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                Drug Safety and Availability

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          FDA Drug Safety Communication: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CRDrug Safety and Availability FDA Drug Safety Communication: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR
  
  	
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    PrintThis update is in follow-up to the FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) issued on 1/10/2013.

en Español

**Safety Announcement**

**[5-14-2013]** The U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs.

FDA is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR)―either 6.25 mg or 12.5 mg―should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities. This new recommendation has been added to the *Warnings and Precautions* section of the physician label and to the patient Medication Guide for zolpidem extended-release (Ambien CR).

Also included in the updated label are the dosing recommendations previously stated in FDA’s January 2013 Drug Safety Communication: The recommended initial dose of certain immediate-release zolpidem products (Ambien and Edluar) is 5 mg for women and either 5 mg or 10 mg for men. The recommended initial dose of zolpidem extended-release (Ambien CR) is 6.25 mg for women and either 6.25 or 12.5 mg for men. If the lower doses (5 mg for immediate-release, 6.25 mg for extended-release) are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release. However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness.

Health care professionals and patients can access the latest drug labels below.

AmbienAmbien CREdluar

Related Information

FDA Drug Safety Podcast: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR
	FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)
	Ambien Drug Details
	Ambien CR Drug Details
	Edluar Drug Details
	Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA aprueba cambios de etiqueta para los productos con zolpidem, que incluyen nueva dosificaciÃn y una recomendaciÃn de evitar conducir el dÃ­a posterior al uso de Ambien CR

                                                                                  Content current as of:
      12/11/2017
              
              
Regulated Product(s)
		 DrugsDrug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
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