The US Food & Drug Administration has updated its safety label changes database with several changes for sleep aids Ambien and Ambien CR (zolpidem tartrate), including the risk of respiratory depression.

As of February 23, updates (in italics) include:

  • The risk of respiratory depression should be considered prior to prescribing AMBIEN in patients with respiratory impairment including sleep apnea and myasthenia gravis or with concomitant opioid use
  • AMBIEN may affect the way other medicines work, and other medicines may affect how AMBIEN works. Especially tell your healthcare provider if you: take benzodiazepines, take opioids as it may increase the risk of breathing problems (respiratory depression), take tricyclic antidepressants, take other medicines that can make you sleepy or affect your breathing (including other zolpidem medicines), drink alcohol.
  • There have been postmarketing reports of delirium with zolpidem use. 
  • AMBIEN can make you sleepy or dizzy and can slow your thinking and motor skills. Because AMBIEN can make you sleepy or dizzy you are at a higher risk for falls.
  • Added to side effects: Problems with your nervous system caused by severe liver disease (hepatic encephalopathy).
  • Withdrawal symptoms. You may have withdrawal symptoms if you stop taking AMBIEN suddenly. Withdrawal symptoms can be serious and include stomach and muscle cramps, vomiting, sweating, shakiness, seizures, and confusion (delirium). Talk to your healthcare provider about slowly stopping AMBIEN to avoid withdrawal symptoms.
  • Keep AMBIEN in a safe place to protect it from theft.
  • AMBIEN is not recommended for use in children under the age of 18 years.

AMBIEN continues to have a black-box warning about rare but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines.