zolpidem (Ambien, Zolpimist, Edluar, Intermezzo)

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Introduction

Tradename: Ambien. DEA-controlled substance: class 4.

Indications

  • treatment of insomnia
    • delayed sleep onset or sleep maintenance in elderly
  • Ambien CR, but not Ambien is FDA approved for long-termuse
  • Intermezzo FDA-approved for early awakening

Contraindications

Caution:

pregnancy category = b

safety in lactation = -

Dosage

Tabs: 5 & 10 mg.

Ambien CR 6.25 & 12.5 mg.

  • 5 or 10 mg immediate release component & 1.25 or 2.5 mg of extended release component

Zolpimist oral spray

Edluar sublingual formulation

Intermezzo sublingual formulation

Pharmacokinetics

elimination via liver

1/2life = 2.5-5 hours

elimination by hemodialysis = -

protein binding = 92 %

Adverse effects

(infrequent)

* Boxed warning:

  • rare risks for sleepwalking, sleepdriving, & other unusual behaviors (i.e., using a stove while sleeping)[17]

Drug interactions

  • any drug that inhibits cyt P450 3A4 may increase levels of zolpidem
  • any drug that induces cyt P450 3A4 may diminish levels of zolpidem

Laboratory

  • therapeutic range: 80-150 ng/mL

Mechanism of action

Notes

  • higher than recommended doses in the elderly & prolonged use common[16]

More general terms

Additional terms

References

  1. The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. Medical Knowledge Self Assessment Program (MKSAP) 11, American College of Physicians, Philadelphia 1998
  3. Drugdex(R) Drug Evaluation
  4. Prescriber's Letter 13(3): 2006 Cytochrome P450 drug interactions Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220233&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. 5.0 5.1 Geriatric Dosage Handbook, 6th edition, Selma et al eds, Lexi-Comp, Cleveland, 2001
  6. Prescriber's Letter 12(9): 2005 Comparison of Insomnia Treatments Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=211015&pb=PRL (subscription needed) http://www.prescribersletter.com
  7. 7.0 7.1 Prescriber's Letter 13(4): 2006 Ambien-Induced Parasomnias (Sleep Disorders) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220402&pb=PRL (subscription needed) http://www.prescribersletter.com
  8. 8.0 8.1 Frey DJ et al. Influence of zolpidem and sleep inertia on balance and cognition during nighttime awakening: A randomized placebo- controlled trial. J Am Geriatr Soc 2011 Jan; 59:73 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21226678
  9. 9.0 9.1 Bocca M-L et al. Zolpidem and zopiclone impair similarly monotonous driving performance after a single nighttime intake in aged subjects. Psychopharmacology (Berl) 2011 Apr; 214:699 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21086117
  10. 10.0 10.1 Jeffrey S Medscape Oncology FDA Approves Intermezzo, First Drug for Early Wakening http://www.medscape.com/viewarticle/754201?sssdmh=dm1.736760&src=nl_newsalert
  11. Department of Veterans Affairs, VA National Formulary
  12. 12.0 12.1 Kolla BP et al Zolpidem is independently associated with increased risk of inpatient falls. Journal of Hospital Medicine, Nov 19, 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23165956 <Internet> http://onlinelibrary.wiley.com/doi/10.1002/jhm.1985/abstract
  13. 13.0 13.1 13.2 FDA MedWatch: Jan 10, 2013 Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses Including Ambien, Ambien CR, Edluar, and Zolpimist http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm
  14. 14.0 14.1 SAMHSA. May 1, 2013 The DAWN Report. Drug Abuse Reporting Network. Emergency Department Visits for Adverse Reactions Involving the Insomnia Medication Zolpidem. http://www.samhsa.gov/data/2k13/DAWN079/sr079-Zolpidem.htm
  15. 15.0 15.1 Lin F-Y et al. Retrospective population cohort study on hip fracture risk associated with zolpidem medication. Sleep 2014 Apr; 37:673 http://www.journalsleep.org/ViewAbstract.aspx?pid=29396
  16. 16.0 16.1 Moore TJ, Mattison DR. Assessment of patterns of potentially unsafe use of zolpidem. JAMA Intern Med 2018 Jul 16; PMID: https://www.ncbi.nlm.nih.gov/pubmed/30014137 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2687525
  17. 17.0 17.1 FDA News Release. April 30, 2019 FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines. Updated warnings for eszopiclone, zaleplon and zolpidem. https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warnings-about-rare-serious-incidents-related-certain-prescription-insomnia
  18. Marbin A et al Zaleplon Versus Zolpidem Use in Older Adults Being Treated for Insomnia: A Review. Am J Geriatr Psychiatr. 2023. 31(3)S68-S69 Not indexed in PubMed https://www.sciencedirect.com/science/article/abs/pii/S1064748123000544

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