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Medications: Lunesta® – eszopiclone

MEDICATIONS

Lunesta® – eszopiclone (View the FDA label)

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

DOSAGE AND ADMINISTRATION
Non-Elderly Adults: 2 mg starting dose immediately before bedtime. May start or increase to 3 mg if clinically indicated since 3 mg is more effective for sleep maintenance (2.1)

Elderly: For difficulty falling asleep 1 mg immediately before bedtime. For difficulty staying asleep 2 mg immediately before bedtime (2.1)

Severe Hepatic Impairment: Starting dose 1 mg (2.1) Patients Taking Concomitant Potent CYP3A4 Inhibitors: Do not exceed a 1 mg starting dose. Maximum dose is 2 mg (2.1)

Do not take with or immediately after a meal (2.1)

DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg (3)

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)

Evaluate for Co-Morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use (5.1)

Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur (5.2)

Abnormal Thinking, Behavioral Changes (e.g., hallucinations, Complex Behaviors (e.g., “sleep-driving”): Immediately evaluate if occurs (5.3)

Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose (5.3, 5.7)

Withdrawal Effects (symptoms may occur with rapid dose reduction or discontinuation) (5.4, 9.3)

CNS Depressant Effects: Use can impair alertness and motor coordination. If used in combination with other CNS depressants, dose reductions may be needed due to additive effects. Do not take together with ethanol (5.5, 5.7, 7.1)

Elderly Patients: Use lower dose due to impaired motor, cognitive performance and increased sensitivity (2.1, 5.7)

Patients with hepatic impairment, impaired respiratory function, impaired drug metabolism or hemodynamic responses: Use with caution (5.7)

Lexapro

CNS Depressants: Additive CNS-depressant effects with combination use. Use with ethanol causes additive psychomotor impairment (7.1)

Rifampicin: Combination use may decrease exposure to and effects of LUNESTA (7.2)

Ketoconazole: Combination use increases exposure to and effect of LUNESTA. Dose reduction of LUNESTA is needed (7.2)

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.

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. 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-to-date information on the management of hypnotic drug product overdosage.

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
Non-Elderly Adults: 2 mg starting dose immediately before bedtime. May start or increase to 3 mg if clinically indicated since 3 mg is more effective for sleep maintenance (2.1)

Elderly: For difficulty falling asleep 1 mg immediately before bedtime. For difficulty staying asleep 2 mg immediately before bedtime (2.1)

Severe Hepatic Impairment: Starting dose 1 mg (2.1) Patients Taking Concomitant Potent CYP3A4 Inhibitors: Do not exceed a 1 mg starting dose. Maximum dose is 2 mg (2.1)

Do not take with or immediately after a meal (2.1)

DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg (3)

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

Evaluate for Co-Morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use (5.1)

Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur (5.2)

Abnormal Thinking, Behavioral Changes (e.g., hallucinations, Complex Behaviors (e.g., “sleep-driving”): Immediately evaluate if occurs (5.3)

Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose (5.3, 5.7)

Withdrawal Effects (symptoms may occur with rapid dose reduction or discontinuation) (5.4, 9.3)

CNS Depressant Effects: Use can impair alertness and motor coordination. If used in combination with other CNS depressants, dose reductions may be needed due to additive effects. Do not take together with ethanol (5.5, 5.7, 7.1)

Elderly Patients: Use lower dose due to impaired motor, cognitive performance and increased sensitivity (2.1, 5.7)

Patients with hepatic impairment, impaired respiratory function, impaired drug metabolism or hemodynamic responses: Use with caution (5.7)

Lexapro

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 to and effects of LUNESTA (7.2)

Ketoconazole: Combination use increases exposure to 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.

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. 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-to-date information on the management of hypnotic drug product overdosage.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

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