Dosing & Uses
Dosage Forms & Stengths
tablet: Schedule IV
- 1mg
- 2mg
- 3mg
Insomnia
Starting dose: 1 mg PO HS for nonelderly adults (both men and women)
Dose may be increased to 2-3 mg HS if clinically indicated
Higher doses are known to cause next morning drowsiness/impairment
Dosing Considerations
Data in adults (aged 25-40 yr) taking eszopiclone 3 mg showed blood levels may remain high enough the following morning (7.5 hr after administration) to impair activities that require alertness, including driving
Impairment to driving skills, memory, and coordination persisted as long as 11 hr after the drug was taken
Despite these long-lasting effects, patients were often unaware they were impaired
Dosage Modifications
CYP3A inhibitors: Do not exceed starting dose of 1 mg HS; may increase to 2 mg if needed
Renal impairment: No dose adjustment required
Dosage adjustments may be needed when coadministered with other CNS depressants to avoid additive effects
Hepatic impairment
- Mild-to-moderate: No dose adjustment required
- Severe: 1 mg PO HS
Administration
Take immediately before bedtime, with at least 7-8 hr remaining before the planned before awakening
Taking with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce efficacy
Safety and efficacy not established
Insomnia
Starting dose: 1 mg PO HS recommended for elderly or debilitated individuals
Not to exceed 2 mg total dose
Higher doses are known to cause next morning drowsiness/impairment
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Headache (13-21%)
Unpleasant taste (17-34% in non-elderly)
1-10%
Abnormal dreams (elderly)
Accidental injury (elderly)
Diarrhea
Dizziness
Dry mouth
Dyspepsia
Nervousness
Neuralgia
Pain
Pruritus
Rash (in non-elderly)
Somnolence
Unpleasant taste (elderly)
UTI
<1%
Agitation
Alopecia
Angioedema
Asthma
Anorexia
Cystitis
Dysphagia
Fever
Epistaxis
Hypertension
Hostility
Hypercholesterolemia
Hypokalemia
Postmarketing Reports
Dysosmia
Complex sleep behaviors
Warnings
Black Box Warnings
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur with therapy; some of these events may result in serious injuries, including death; discontinue therapy immediately if patient experiences a complex sleep behavior
Contraindications
Documented hypersensitivity
Patients who have experienced complex sleep behaviors after receiving therapy
Cautions
Take immediately before going to bed - taking earlier may cause memory loss, hallucinations, dizziness, lightheadedness
Can impair daytime function in some patients at the higher doses (2 mg or 3 mg), even when used as prescribed; monitor for next day next-day psychomotor impairment
Take only when able to have a full night of sleep (7-8 hr); coadministration with other sedative-hypnotics at bedtime or taking eszopiclone the middle of the night is not recommended because of risk for next-day psychomotor impairment
May cause CNS depression and impair physical and mental abilities
May worsen clinical depression
Use minimum dose that will effectively treat patient; write prescription for smallest quantity consistent with good patient care
May cause abnormal thinking & bizarre behavior
May impair ability to drive or operate heavy machinery
Caution in history of drug or substance abuse, respiratory diseases, hepatic impairment
Amnesia may occur
Failure of sleep disturbance to resolve after 7-10 days may indicate psychiatric and/or medical illness
Abrupt discontinuation or rapid dose decreases may lead to withdrawal symptoms
Therapy can cause drowsiness and a decreased level of consciousness; patients, particularly the elderly, are at higher risk of falls
Complex sleep behavior
- Behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following first or any subsequent use of drug
- Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) also reported
- Patients can be seriously injured or injure others during complex sleep behaviors
- Patients usually do not remember events
- Post-marketing reports have shown that complex sleep behaviors may occur with drug alone at recommended dosages, with or without the concomitant use of alcohol or other CNS depressants
- Concomitant administration with other CNS depressants, may increase risk of sleep-related episodes
- Discontinue treatment in patients reporting any sleep-related activities
Pregnancy & Lactation
Pregnancy
Available pharmacovigilance data with use in pregnant women are insufficient to identify drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
- In animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity; administration to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; lowest dose was approximately 200 times maximum recommended human dose (MRHD) of 3 mg/day based on mg/ m² body surface area
Lactation
There are no data on prescence in either human or animal milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Unknown, may interact with GABA receptor complexes at binding domains allosterically couppled to benzodiazepine receptors
Pharmacokinetics
Absorption: Rapid (attenuated by high-fat meal)
Protein Bound: 52-59%
Peak Plasma Time: 1 hr
Half-life, elimination: 6 hr (<65 years old); 9 hr (≥65 years)
Metabolism: Primarily by CYP3A4 & CYP2E1 via oxidation & demethylation
Metabolites: (S)-zopiclone-N-oxide & (S)-N-desmethylzopiclone
Excretion: Urine (85%)
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Patient Handout
Formulary
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