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LUNESTA (ESZOPICLONE): PRECAUTIONS

General

Timing of Drug Administration

Lunesta (Eszopiclone) tablets should be taken immediately before bedtime. Taking a sedative/hypnotic while still up and about may result in short-term memory impairment, hallucinations, impaired coordination, dizziness, and lightheadedness.

Use in The Elderly and/or Debilitated Patients

Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. The recommended starting dose of Lunesta (Eszopiclone) for these patients is 1 mg.

Use in Patients with Concomitant Illness

Clinical experience with eszopiclone in patients with concomitant illness is limited. Eszopiclone (Lunesta) should be used with caution in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

A study in healthy volunteers did not reveal respiratory-depressant effects at doses 2.5-fold higher (7 mg) than the recommended dose of eszopiclone. Caution is advised, however, if Lunesta (Eszopiclone) is prescribed to patients with compromised respiratory function.

The dose of Eszopiclone (Lunesta) tablets should be reduced to 1 mg in patients with severe hepatic impairment, because systemic exposure is doubled in such subjects. No dose adjustment appears necessary for subjects with mild or moderate hepatic impairment. No dose adjustment appears necessary in subjects with any degree of renal impairment, since less than 10% of eszopiclone is excreted unchanged in the urine.

The dose of Lunesta should be reduced in patients who are administered potent inhibitors of CYP3A4, such as ketoconazole, while taking Eszopiclone. Downward dose adjustment is also recommended when this medicine is administered with agents having known CNS-depressant effects.

Use in Patients with Depression

Sedative/hypnotic drugs should be administered with caution to patients exhibiting signs and symptoms of depression. Suicidal tendencies may be present in such patients, and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.

Information for Patients

Patients should be instructed to read the accompanying Medication Guide with each new prescription and refill. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be given the following information:

  • Patients should be instructed to take Lunesta (Eszopiclone) immediately prior to going to bed, and only if they can dedicate 8 hours to sleep.
  • Patients should be instructed not to take Lunesta (Eszopiclone) tablets with alcohol or with other sedating medications.
  • Patients should be advised to consult with their physician if they have a history of depression, mental illness, or suicidal thoughts, have a history of drug or alcohol abuse, or have liver disease.
  • Women should be advised to contact their physician if they become pregnant, plan to become pregnant, or if they are nursing.

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