Ambien CR

See also: Generic Ambien

Ambien CR is a brand name of zolpidem, approved by the FDA in the following formulation(s):

AMBIEN CR (zolpidem tartrate - tablet, extended release; oral)

• 
  Manufacturer: SANOFI AVENTIS US
  
  Approval date: September 2, 2005
  
  Strength(s): 12.5MG ^[RLD][AB], 6.25MG ^[AB]

Has a generic version of Ambien CR been approved?

A generic version of Ambien CR has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Ambien CR and have been approved by the FDA:

zolpidem tartrate tablet, extended release; oral

• 
  Manufacturer: ACTAVIS S ATLANTIC
  
  Approval date: October 13, 2010
  
  Strength(s): 6.25MG ^[AB]


• 
  Manufacturer: ANCHEN PHARMS
  
  Approval date: December 3, 2010
  
  Strength(s): 12.5MG ^[AB]


• 
  Manufacturer: ANCHEN PHARMS
  
  Approval date: April 14, 2011
  
  Strength(s): 6.25MG ^[AB]


• 
  Manufacturer: SANDOZ
  
  Approval date: July 1, 2011
  
  Strength(s): 12.5MG ^[AB], 6.25MG ^[AB]


• 
  Manufacturer: SYNTHON PHARMS
  
  Approval date: April 12, 2011
  
  Strength(s): 6.25MG ^[AB]


• 
  Manufacturer: SYNTHON PHARMS
  
  Approval date: June 6, 2011
  
  Strength(s): 12.5MG ^[AB]

ZOLPIDEM TATRATE (zolpidem tartrate tablet, extended release; oral)

• 
  Manufacturer: ACTAVIS S ATLANTIC
  
  Approval date: June 6, 2011
  
  Strength(s): 12.5MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ambien CR. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Controlled-release dosage forms comprising zolpidem or a salt thereof
  Patent 6,514,531
  Issued: February 4, 2003
  Inventor(s): Gérard; Alaux & Gareth; Lewis & Frédéric; Andre
  Assignee(s): Sanofi-Synthelabo
  The present invention relates to controlled-release dosage forms of zolpidem or salts thereof adapted to release zolpidem over a predetermined time period, according to a biphasic profile of dissolution, where the first phase is an immediate release phase and the second phase is a prolonged release phase and particular embodiments thereof intended to avoid abuse.
  
  Patent expiration dates:
  
  
  • December 1, 2019
    
    ✓ 
    Drug product
  
  
  
  • June 1, 2020
    
    ✓ 
    Pediatric exclusivity
  
  

See also...

• Ambien CR Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Ambien CR Consumer Information (Cerner Multum)
• Ambien CR Advanced Consumer Information (Micromedex)
• Zolpidem Consumer Information (Drugs.com)
• Zolpidem Consumer Information (Wolters Kluwer)
• Zolpidem Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Zolpidem Oral Spray Consumer Information (Wolters Kluwer)
• Zolpidem Consumer Information (Cerner Multum)
• Zolpidem Oral, Oromucosal Advanced Consumer Information (Micromedex)
• Zolpidem Tartrate AHFS DI Monographs (ASHP)