Women taking sleep medication at greater risk of impairment the next day

Earlier this year, the U.S. Food and Drug Administration recommended giving patients lower doses of medications containing zolpidem. The recommendation comes after new evidence linking the active ingredient to impairment the morning after taking the medication – especially in women, who metabolize the medication more slowly. The risk appears to be highest with extended-release formulations and with higher doses of zolpidem medications. The FDA now requires manufacturers of medications containing zolpidem – which include Ambien®, Ambien CR®, Zolpimist® and Edluar® – to adjust their labels to reflect these new dosing recommendations. ¹

Throughout the past several years, several reports have linked zolpidem to motor vehicle accidents, but this association was difficult to confirm. During driving simulation and laboratory studies, blood concentrations exceeding 50ng/mL correlated with impaired driving ability and an increased risk of motor vehicle accidents. According to these studies, 8 hours after a dose of zolpidem, women were more likely to have blood level concentrations greater than 50ng/mL, even when they reported feeling fully awake. Finally, Ambien CR® was reported to have a higher likelihood of next-morning impairment versus Ambien® immediate-release products. The results of these studies directly influenced the recommended doses of the newest zolpidem product, Intermezzo®, as well as the new labeling recommendations for the other medications containing zolpidem.¹

For patients, other options are available:

  • Sleep hygiene and cognitive behavioral therapy remain the first line of treatment.²
  • Trazodone has been shown to be beneficial.²
  • Melatonin preparations may be helpful, especially when insomnia is related to jet lag.³
  • Lower doses of zolpidem products should be effective in most women and men.¹
  • Non-benzodiazepine hypnotic sleep agents are not effective for chronic use (longer than 90 days), and even in the short term, agents such as zolpidem have been shown to have only minimal improvements in sleep latency and duration.
Product New FDA Dosing Recommendations
For non-elderly adults
Dosing Recommendations for Elderly
Zolpidem immediate-release (Ambien®, Edluar®, Zolpimist®) Women:
5 mg once daily, before bedtime
Men:
5 or 10 mg once daily, before bedtime
Recommended to start with lower dose
Women and men:
5 mg once daily, before bedtime
Zolpidem extended-release (Ambien CR®) Women:
6.25 mg once daily, before bedtime
Men:
6.25 or 12.5 mg once daily, before bedtime
Recommended to start with lower dose
Women and men:
6.25 mg once daily, before bedtime
  1. FDA 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). Jan 2013.
  2. "Ambien CR, Intermezzo, Silenor Prior Authorization Policy." Providence Health Plans/Oregon Region Pharmacy and Therapeutics Committee. 08/2008.
  3. Schutte-Rodin S, Broch L, Buysse D, et al. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 :4 :487-504.