eszopiclone (Lunesta)

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Introduction

Tradename: Lunesta (FDA-controlled substance class 4)

Indications

* carries same risks as benzodiazepines; not a safer alternative

Contraindications

Pregnancy category: C

Dosage

  • starting dose 1 mg QHS[3]
  • maintenance: 2-3 mg QHS; 1-2 mg QHS (elderly)*
  • lower dose for difficulty falling asleep; higher dose for difficulty maintaining sleep[2]
  • maximum dose of 1 mg with severe hepatic impairment

* recommended does reduced to 1 mg QHS because of impaired driving skills, memory impairment, & loss of coordination at 3 mg dose[4]

Tabs: 1,2,3 mg.

Pharmacokinetics

Adverse effects

* 3 mg QHS dose[4]

* carries same risks as benzodiazepines; not a safer alternative

* Boxed warning:

  • rare risks for sleepwalking, sleepdriving, & other unusual behaviors (i.e., using a stove while sleeping)[5]

Laboratory

Notes

Manufacturer: Sepracor

More general terms

References

  1. Prescriber's Letter 12(2): 2005 New Drugs Approved by the FDA in 2004 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210216&pb=PRL (subscription needed) http://www.prescribersletter.com
  2. Jump up to: 2.0 2.1 2.2 2.3 2.4 Prescriber's Letter 12(3): 2005 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210305&pb=PRL (subscription needed) http://www.prescribersletter.com
  3. Jump up to: 3.0 3.1 3.2 FDA MedWatch. May 15, 2014 Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397536.htm
  4. Jump up to: 4.0 4.1 4.2 Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018
  5. Jump up to: 5.0 5.1 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
  6. Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022
  7. Jump up to: 7.0 7.1 NEJM Knowledge+
    Winkelman JW Insomnia Disorder N Engl J Med 2015; 373:1437-1444. October 8, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26444730 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMcp1412740

Database