Uses
Insomnia
Management of transient and chronic insomnia.
Decreases sleep latency and prolongs total sleep time in patients with chronic or transient insomnia; reportedly effective with repeated (i.e., nightly) use for periods up to 6 months in duration.
Sleep architecture (i.e., the percentage of time spent in each sleep stage) generally is preserved at usual dosages.
Evidence is lacking to suggest that sleep improvement is maintained following discontinuance; some clinicians suggest that use of hypnotic agents in the management of chronic insomnia should be reserved for patients nonresponsive to psychotherapy/behavioral therapies (e.g., relaxation techniques, sleep hygiene education, sleep curtailment, stimulus control therapy).
Dosage and Administration
Administration
Oral Administration
Administer only immediately before retiring (when ready to sleep) or after retiring when experiencing difficulty falling asleep.
Swallow tablets intact; do not chew, crush, or divide.
Avoid administration with or immediately after a heavy, high-fat meal; may decrease rate of absorption and effect on sleep latency.
Use only when able to get ≥8 hours of sleep before it is necessary to be active again.
Dosage
Individualize dosage; use smallest effective dosage to minimize adverse effects.
If used concomitantly with a potent CYP3A4 inhibitor, adjustment of eszopiclone dosage is recommended. (See Interactions.)
Adults
Insomnia
Oral
Adults <65 years of age: Initially, 2 mg. May consider an initial dosage of 3 mg or an increase in dosage to 3 mg if clinically indicated; 3-mg dosage is more effective than 2-mg dosage for sleep maintenance.
Special Populations
Dosage in Hepatic Impairment
In patients with severe hepatic impairment, 1 mg initially; doses >2 mg not recommended.
No dosage adjustment required in patients with mild to moderate hepatic impairment.
Dosage in Renal Impairment
No dosage adjustment required.
Geriatric Patients
In adults ≥65 years of age experiencing difficulty falling asleep, 1 mg initially. May increase dosage to 2 mg if clinically indicated.
In adults ≥65 years of age experiencing difficulty staying asleep, 2 mg.
Do not exceed 2 mg daily in adults ≥65 years of age.
Debilitated Patients
Do not exceed 1 mg.
Cautions
Contraindications
Warnings/Precautions
Warnings
Adequate Patient Evaluation
Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.
Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric and/or medical condition.
Adverse Psychiatric Events
Abnormal thinking and behavioral changes (e.g., decreased inhibition, uncharacteristic extroversion and aggressiveness, bizarre behavior, agitation, hallucinations, depersonalization, amnesia) may occur unpredictably. Immediately evaluate any new behavioral sign or symptom.
Complex Sleep-related Behaviors
Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug, with no memory of the event), making phone calls, or preparing and eating food while asleep.
Withdrawal Effects
Rapid dosage reduction or abrupt discontinuance of sedatives or hypnotics has resulted in signs and symptoms of withdrawal.
Rebound insomnia of 1 day’s duration reported in clinical trials of eszopiclone.
Abuse Potential
Abuse potential of high doses (2–4 times recommended hypnotic dose) in individuals with a history of benzodiazepine abuse appeared to be similar to that of benzodiazepines (e.g., diazepam 20 mg).
Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.
CNS Effects
Rapid onset of CNS effects (short-term memory impairment, hallucinations, impaired coordination, dizziness, lightheadedness); administer only immediately before going to bed or after unsuccessfully attempting to sleep.
Performance of activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle) may be impaired the day after ingestion.
Concurrent use of other CNS depressants may cause additive or potentiated CNS depression. (See Specific Drugs under Interactions.)
Sensitivity Reactions
Potential risk of anaphylaxis and angioedema; may occur as early as with the first dose of drug.
General Precautions
Concomitant Disease
Limited experience in patients with concomitant systemic disease. Use with caution in patients with diseases affecting metabolism and/or hemodynamic response.
Respiratory depression was not reported in clinical studies to date in healthy individuals receiving doses 2.5-fold higher than the recommended dose; however, caution is advised in patients with impaired respiratory function.
Debilitated Patients
Potential increased sensitivity to sedatives and hypnotics or impaired motor or cognitive performance after repeated exposure. Reduce dosage and monitor closely. (See Debilitated Patients under Dosage and Administration.)
Suicide
Use with caution in depressed patients. Potential for suicidal tendencies; overdosage more frequent in such patients. Prescribe and dispense drug in the smallest feasible quantity.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether distributed into human milk; however, racemic zopiclone is distributed into milk. Use not recommended.
Pediatric Use
Safety and efficacy not established in children <18 years of age.
Geriatric Use
Pharmacokinetic changes in geriatric patients compared with younger adults. (See Absorption and also Elimination, under Pharmacokinetics.)
Possibility exists of greater sensitivity to pharmacologic and adverse effects of sedatives and hypnotics in patients ≥65 years of age; reduce initial and maximum dosages. (See Geriatric Patients under Dosage and Administration.)
The adverse effect profile of the 2-mg dosage in geriatric patients (median age: 71 years) was similar to that observed in clinical trials of the drug in younger adults.
Hepatic Impairment
Use with caution. Systemic exposure increased twofold in patients with severe hepatic impairment compared with healthy individuals. Reduce dosage for severe hepatic impairment. (See Hepatic Impairment under Dosage and Administration.)
Common Adverse Effects
Headache, dry mouth, dizziness, somnolence, nervousness, dyspepsia, nausea, infection, unpleasant taste.
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