New data show that evening dosing of any formulation of zolpidem leads to high morning blood levels in some patients. This may lead to impairment of mental alertness, including impairments to driving.11 The data also show who has the highest risk when using the extended-release forms of these drugs, with women appearing more vulnerable due to slower zolpidem elimination compared to men. Manufacturers of brand name products of zolpidem are being mandated by the FDA to lower the recommended dose. For the immediate-release product, the recommended dose for women will be lowered from 10 mg to 5 mg, and the recommended dose for the extended-release products will be lowered from 12.5 mg to 6.25 mg. The lower dose Intermezzo product will not undergo a label change. The same lower doses are also recommended for men. In the pharmacokinetic data reviewed by the FDA, zolpidem blood concentrations exceeding 50 ng/mL approximately eight hours postdosing were found in approximately 33% of women and 25% of men. In addition, approximately 5% of patients had blood levels greater than or equal to 100 ng/mL. Zolpidem blood levels above 50 ng/mL seem capable of impairing driving, increasing motor vehicle accident risk. The FDA is evaluating next-morning impairment with other hypnotic agents.
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Explore This IssueMarch 2013
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Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City, a clinical pharmacist at New York Downtown Hospital, and adjunct faculty at Touro College of Pharmacy.
- FDA approves Kineret for the treatment of NOMID. Published January 8, 2013. Available at www.firstwordpharma.com/node/1047984. Accessed January 9, 2013.
- U.S. Food And Drug Administration (FDA) accepts new drug application for bazedoxifene/conjugated estrogens, an investigational treatment for symptoms associated with menopause and prevention of osteoporosis. Published December 13, 2012. Available at http://investor.ligand.com/Investors/News-and-Events/Press-Releases/Press-Release-Details/2012/US-Food-And-Drug-Administration-FDA-Accepts-New-Drug-Application-For-BazedoxifeneConjugated-Estrogens-An-Investigational-Trea/default.aspx. Accessed January 17, 2013.
- Interleukin-1 beta inhibitor provides significant relief in childhood arthritis. Published December 20, 2012. Available at www.empr.com/interleukin-1-beta-inhibitor-provides-significant-relief-in-childhood-arthritis/article/273433/. Accessed January 17, 2013.
- AstraZeneca announces top-line results of OSKIRA-4 Phase IIb study of fostamatinib as a monotherapy for rheumatoid arthritis. Published December 13, 2012. Available at www.astrazeneca.com/Media/Press-releases/Article/20121213-AstraZeneca-announces-results-OSKIRA-4-study-fostamatinib. Accessed January 18, 2013.
- Pittman D. FDA panel to review opioid. Published December 6, 2012. Available at www.medpagetoday.com/PainManagement/PainManagement/36295. Accessed December 7, 2012.
- Breckenridge launches generic Prevacid capsules. Published December 19, 2012. Available at www.empr.com/breckenridge-launches-generic-prevacid-capsules/article/273244/. Accessed January 7, 2013.
- Antares Pharma announces submission of new drug application for Otrexup. Published December 17, 2012. Available at www.antarespharma.com/files/3513/5575/4546/OTREXUP_NDA_SUBMISSION_Final_Decemebr_14_2102 .pdf. Accessed January 17, 2013.
- Dennis M. Eli Lilly ends late-stage study of experimental arthritis drug tabalumab due to lack of efficacy. Published December 13, 2012. Available at www.firstwordpharma.com/forward/emailref?path=node/1041616. Accessed December 14, 2012.
- FDA approves expanded indication for ACTEMRA in Rheumatoid arthritis. Published October 12, 2012. Available at www.gene.com/media/press-releases/14187/2012-10-12/fda-approves-expanded-indication-for-act/. Accessed January 17, 2013.
- Chappelle R. FDA approves Varizig for reducing chicken pox symptoms. Published December 21, 2012. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333233.htm. Accessed January 18, 2013.
- 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). Published January 10, 2013. Available at www.fda.gov/Drugs/DrugSafety/ucm334033.htm. Accessed January 10, 2013.