INDICATION AND USES:
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)
SIDE EFFECTS:
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)
CONTRAINDICATIONS:
- Patients who have experienced complex sleep behaviors after taking LUNESTA (4)
- Known hypersensitivity to eszopiclone (4)
WARNINGS AND PRECAUTIONS:
- CNS Depressant Effects Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients taking 3 mg dose against driving and against activities requiring complete mental alertness during the morning after use. (5.2)
- Evaluate for Comorbid Diagnoses Reevaluate if insomnia persists after 7 to 10 days of use (5.3)
- Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur (5.4)
- Abnormal Thinking and Behavioral Changes Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported. Immediately evaluate any new onset of behavioral changes (5.5)
- Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose (5.5, 5.8)
- Withdrawal Effects Symptoms may occur with rapid dose reduction or discontinuation (5.6, 9 3)
- Elderly Patients Use lower dose due to impaired motor, cognitive performance and increased sensitivity (2.2, 5.8)
- Patients with Hepatic Impairment, Impaired Respiratory Function, Impaired Drug Metabolism or Hemodynamic Responses Use with caution (5.8)
Lexapro
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)
OVERDOSE:
In clinical trials with eszopiclone, one case of overdose with up to 36 mg of eszopiclone was reported in which the subject fully recovered. Since commercial marketing began, spontaneous cases of eszopiclone overdoses up to 270 mg (90 times the maximum recommended dose of eszopiclone) have been reported, in which patients have recovered. Fatalities related to LUNESTA overdoses were reported only in combination with other CNS drugs or alcohol.
Signs and Symptoms: Signs and symptoms of overdose effects of CNS depressants can be expected to present as exaggerations of the pharmacological effects noted in preclinical testing. Impairment of consciousness ranging from somnolence to coma has been described. Rare individual instances of fatal outcomes following overdose with racemic zopiclone have been reported in European postmarketing reports, most often associated with overdose with other CNS-depressant agents. Methemoglobinemia in association with overdoses of racemic zopiclone has been reported.
Recommended Treatment: General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Flumazenil may be useful. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Consider monitoring methemoglobin in the setting of high-dose overdosage. The value of dialysis in the treatment of overdosage has not been determined. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-todate information on the management of hypnotic drug product overdosage.
- Uses
-
INDICATION AND USES:
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)
- Side Effects
-
SIDE EFFECTS:
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)
- Precautions
-
CONTRAINDICATIONS:
- Patients who have experienced complex sleep behaviors after taking LUNESTA (4)
- Known hypersensitivity to eszopiclone (4)
WARNINGS AND PRECAUTIONS:
- CNS Depressant Effects Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients taking 3 mg dose against driving and against activities requiring complete mental alertness during the morning after use. (5.2)
- Evaluate for Comorbid Diagnoses Reevaluate if insomnia persists after 7 to 10 days of use (5.3)
- Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur (5.4)
- Abnormal Thinking and Behavioral Changes Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported. Immediately evaluate any new onset of behavioral changes (5.5)
- Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose (5.5, 5.8)
- Withdrawal Effects Symptoms may occur with rapid dose reduction or discontinuation (5.6, 9 3)
- Elderly Patients Use lower dose due to impaired motor, cognitive performance and increased sensitivity (2.2, 5.8)
- Patients with Hepatic Impairment, Impaired Respiratory Function, Impaired Drug Metabolism or Hemodynamic Responses Use with caution (5.8)
Lexapro
- Interactions
-
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)
- Overdose
-
OVERDOSE:
In clinical trials with eszopiclone, one case of overdose with up to 36 mg of eszopiclone was reported in which the subject fully recovered. Since commercial marketing began, spontaneous cases of eszopiclone overdoses up to 270 mg (90 times the maximum recommended dose of eszopiclone) have been reported, in which patients have recovered. Fatalities related to LUNESTA overdoses were reported only in combination with other CNS drugs or alcohol.
Signs and Symptoms: Signs and symptoms of overdose effects of CNS depressants can be expected to present as exaggerations of the pharmacological effects noted in preclinical testing. Impairment of consciousness ranging from somnolence to coma has been described. Rare individual instances of fatal outcomes following overdose with racemic zopiclone have been reported in European postmarketing reports, most often associated with overdose with other CNS-depressant agents. Methemoglobinemia in association with overdoses of racemic zopiclone has been reported.
Recommended Treatment: General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Flumazenil may be useful. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Consider monitoring methemoglobin in the setting of high-dose overdosage. The value of dialysis in the treatment of overdosage has not been determined. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-todate information on the management of hypnotic drug product overdosage.