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eszopiclone (Lunesta)

Tradename: Lunesta (FDA-controlled substance class 4) Indications: - treatment of insomnia (non benzodiazepine)* only sleeping pill NOT labeled for short-term use [2] - useful for sleep maintenance [7] * carries same risks as benzodiazepines; not a safer alternative Contraindications: Pregnancy category: C Dosage: 1) starting dose 1 mg QHS [3] 2) maintenance: 2-3 mg QHS; 1-2 mg QHS (elderly)* 3) lower dose for difficulty falling asleep; higher dose for difficulty maintaining sleep [2] 4) 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: 1) protein-binding 52-59% 2) metabolized in the liver by cyt P450 3A4 & 2E1 [2] 3) tolerance does not develop within 6 months 4) 1/2 life = 6 hours Adverse effects: - bitter taste is most common adverse effect [2] - next-day impairment [3]* - impaired driving skills - memory impairment - loss of coordination - increased risk for falls* * 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: - eszopiclone in urine Mechnanism of action: 1) S-enantiomer of zopiclone, a cyclobenzopyrrlone 2) CNS depression Notes: Manufacturer: Sepracor

Interactions

drug adverse effects of psychotropic agents

General

sedative/hypnotic (tranquilizer) zopiclone (Imovane, Zimovane)

Database Correlations

PUBCHEM cid=969472

References

  1. Prescriber's Letter 12(2): 2005 New Drugs Approved by the FDA in 2004 Detail-Document#: 210216 (subscription needed) http://www.prescribersletter.com
  2. Prescriber's Letter 12(3): 2005 Detail-Document#: 210305 (subscription needed) http://www.prescribersletter.com
  3. 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. Medical Knowledge Self Assessment Program (MKSAP) 18, American College of Physicians, Philadelphia 2018
  5. 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. NEJM Knowledge+ - Winkelman JW Insomnia Disorder N Engl J Med 2015; 373:1437-1444. October 8, 2015 PMID: 26444730 http://www.nejm.org/doi/full/10.1056/NEJMcp1412740