eszopiclone (Rx)

Brand and Other Names:Lunesta
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Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

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            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

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            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

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            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.

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            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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            Images

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            Lunesta oral
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            Lunesta oral
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            Lunesta oral
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            Patient Handout

            Patient Education
            eszopiclone oral

            ESZOPICLONE - ORAL

            (es-zoe-PIK-lone)

            COMMON BRAND NAME(S): Lunesta

            WARNING: Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous (possibly fatal) to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. You should not take this medication or similar medications (such as zaleplon, zolpidem) if you have this reaction to the medication.

            USES: This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Eszopiclone belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using eszopiclone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually just before you get into bed. Do not take it with or right after a high-fat or heavy meal since it may not work as well. The dosage is based on your medical condition, age, liver function, other medications you may be taking, and response to treatment. Do not take more of this medication than prescribed because your risk of side effects will increase. The starting dose is 1 milligram at bedtime as directed. That dosage lessens the risk of having trouble safely doing activities requiring alertness the next day (such as driving or operating machinery). Also, you may not be fully alert the next day, yet you think you are fully alert. If you are prescribed the 3 milligram dosage of eszopiclone, you should not do activities the next day that require alertness. Ask your doctor or pharmacist for more details.If you are an older adult or you have liver disease, a low dose will usually be prescribed to lessen the risk of being impaired the next day. Do not stop your medication without talking to your doctor or pharmacist.Do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss and may have trouble safely doing any activity that requires alertness, such as driving or operating machinery. (See also Precautions section.)If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea, vomiting, flushing, stomach cramps, nervousness, shakiness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used eszopiclone for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.Tell your doctor if your condition lasts after 7 to 10 days, or if it gets worse.You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1 or 2 nights. If this effect continues, contact your doctor.

            SIDE EFFECTS: See also Warning section.Dizziness, dry mouth, unpleasant taste, or difficulty with coordination may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness or falling, get up slowly when rising from a sitting or lying position.This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: See also Warning section.Before taking eszopiclone, tell your doctor or pharmacist if you are allergic to it; or to zopiclone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), mental/mood problems (such as depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of sleepwalking, a certain muscle disease (myasthenia gravis).The effects of this drug can last even after you wake up the next day. If you did not get 7 to 8 hours of sleep or took other medications that made you sleepy or are more sensitive to this drug, you may feel alert but not think clearly enough to drive. Alcohol or marijuana (cannabis) can also make you more sleepy. Wait at least 8 hours after taking this drug before driving, and do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). If you take the 3 milligram dosage of eszopiclone, do not drive, use machinery, or do anything that needs alertness the next day.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling. Also see the How To Use section.During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who take this medication near the time of delivery may have undesirable effects such as excessive sleepiness. Tell your doctor if you notice such effects in your newborn. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: sodium oxybate.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.Eszopiclone is very similar to zopiclone. Do not use medications containing zopiclone while using eszopiclone.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, a deep sleep from which you cannot be awakened.

            NOTES: Do not share this medication with others. Sharing it is against the law.As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.

            MISSED DOSE: If you miss a dose, do not take it unless you have time to sleep for 7 to 8 hours afterward. (See also How to Use section.)

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised January 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.