zolpidem (Ambien, Zolpimist, Edluar, Intermezzo)

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[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]

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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