Eszopiclone | Lunesta

LUNESTA is indicated for the treatment of insomnia. LUNESTA has been shown to decrease sleep latency and improve sleep maintenance (1)

Dosage and Administration:

  • Use the lowest dose effective for the patient (2)
  • Recommended initial dose is 1 mg, immediately before bedtime, with at least 7-8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg (2.1)
  • Geriatric or debilitated patients: Dose should not exceed 2 mg (2.2)
  • Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg (2.3)
  • Do not take with or immediately after a meal (2.5)

Dosage Forms and Strengths: Tablets: 1 mg, 2 mg, and 3 mg

Lunesta

Eszopiclone | Lunesta Prescribing Information Highlights

The following points are shortened, highlighted information from prescribing information for this drug. For the full prescribing information PDF, click the button below to be directed to the FDA PDF label for this drug.

ESZOPICLONE | LUNESTA FULL PRESCRIBING INFO PDF

—–INDICATIONS AND USAGE—–

  • See description above.

—–DOSAGE AND ADMINISTRATION—–

  • See description above.

—–CONTRAINDICATIONS—–

  • Known hypersensitivity to eszopiclone (4)

—–WARNINGS & PRECAUTIONS—–

  • CNS depressant effects: Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose. Caution patients taking 3 mg dose against driving and against activities requiring complete mental alertness during the morning after use. (5.1)
  • Evaluate for Co-Morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use (5.2)
  • Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur (5.3)
  • Abnormal Thinking, Behavioral Changes (e.g., hallucinations), Complex Behaviors (e.g., “sleep-driving”): Immediately evaluate if occurs (5.4)
  • Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose (5.4, 5.7)
  • Withdrawal Effects: symptoms may occur with rapid dose reduction or discontinuation (5.5, 9.3)
  • Elderly Patients: Use lower dose due to impaired motor, cognitive performance and increased sensitivity (2.2, 5.7)
  • Patients with hepatic impairment, impaired respiratory function, impaired drug metabolism or hemodynamic responses: Use with caution (5.7)

—–ADVERSE REACTIONS—–

  • Most commonly observed adverse reactions (incidence ≥2%) were unpleasant taste, headache, somnolence, respiratory infection, dizziness, dry mouth, rash, anxiety, hallucinations, and viral infections (6.1)

—–DRUG INTERACTIONS—–

  • CNS Depressants: Additive CNS-depressant effects with combination use. Use with ethanol causes additive psychomotor impairment (7.1)
  • Rifampicin: Combination use may decrease exposure and effects of LUNESTA (7.2)
  • Ketoconazole: Combination use increases exposure and effect of LUNESTA. Dose reduction of LUNESTA is needed (7.2)

—–USE IN SPECIFIC POPULATIONS—–

  • Pregnancy: Based on animal data, may cause fetal harm (8.1)
  • Pediatric Use: Safety and effectiveness not established. Dizziness, dysgeusia, hallucinations, suicidal ideation reported (8.4)

More Information on Eszopiclone | Lunesta

For more information on this drug and dozens of other leading psychotropics, see our 2018 Black Book of Psychotropic Dosing and Monitoring. Available as a digital PDF download.