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
Contraindicated (2)
- calcium/magnesium/potassium/sodium oxybates
eszopiclone, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.
- sodium oxybate
eszopiclone, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.
Serious - Use Alternative (31)
- abametapir
abametapir will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- amobarbital
amobarbital will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- apalutamide
apalutamide will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- benzhydrocodone/acetaminophen
benzhydrocodone/acetaminophen, eszopiclone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.
- chloramphenicol
chloramphenicol will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- cobicistat
cobicistat will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- conivaptan
conivaptan will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- enzalutamide
enzalutamide will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fentanyl
fentanyl, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.
- fentanyl intranasal
fentanyl intranasal, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.
- fentanyl transdermal
fentanyl transdermal, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.
- fentanyl transmucosal
fentanyl transmucosal, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.
- hydrocodone
hydrocodone, eszopiclone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.
- idelalisib
idelalisib will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- itraconazole
itraconazole will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- ketoconazole
ketoconazole will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lemborexant
lemborexant, eszopiclone. Either increases effects of the other by sedation. Avoid or Use Alternate Drug. Use of lemborexant with other drugs to treat insomnia is not recommended.
- metoclopramide intranasal
eszopiclone, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.
- mifepristone
mifepristone will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nefazodone
nefazodone will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- oxycodone
eszopiclone and oxycodone both increase sedation. Avoid or Use Alternate Drug. Additive CNS depression may lead to hypotension, profound sedation, respiratory depression, or coma
- phenobarbital
phenobarbital will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- posaconazole
posaconazole will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- primidone
primidone will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- secobarbital
secobarbital will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. May also enhance CNS depressant effect of eszopiclone
- selinexor
selinexor, eszopiclone. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- sufentanil SL
sufentanil SL, eszopiclone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.
- tucatinib
tucatinib will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- valerian
valerian and eszopiclone both increase sedation. Avoid or Use Alternate Drug.
- voxelotor
voxelotor will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (59)
- atazanavir
atazanavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- bosentan
bosentan will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- brexanolone
brexanolone, eszopiclone. Either increases toxicity of the other by sedation. Use Caution/Monitor.
- buprenorphine, long-acting injection
eszopiclone increases toxicity of buprenorphine, long-acting injection by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of buprenorphine and benzodiazepines or other CNS depressants increases risk of adverse reactions including overdose, respiratory depression, and death. Cessation of benzodiazepines or other CNS depressants is preferred in most cases. In some cases, monitoring at a higher level of care for tapering CNS depressants may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate.
- carbamazepine
carbamazepine will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
cenobamate, eszopiclone. Either increases effects of the other by sedation. Use Caution/Monitor. - clarithromycin
clarithromycin increases levels of eszopiclone by enhancing GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
clarithromycin increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day. - clobazam
eszopiclone, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).
- crizotinib
crizotinib increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- crofelemer
crofelemer increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.
- darunavir
darunavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- deutetrabenazine
eszopiclone and deutetrabenazine both increase sedation. Use Caution/Monitor.
- diazepam intranasal
diazepam intranasal, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may potentiate the CNS-depressant effects of each drug.
- dichlorphenamide
dichlorphenamide and eszopiclone both decrease serum potassium. Use Caution/Monitor.
- duvelisib
duvelisib will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.
- efavirenz
efavirenz will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- elagolix
elagolix will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- encorafenib
encorafenib, eszopiclone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.
- erythromycin base
erythromycin base increases levels of eszopiclone by enhancing GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
erythromycin base increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day. - erythromycin ethylsuccinate
erythromycin ethylsuccinate increases levels of eszopiclone by enhancing GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
erythromycin ethylsuccinate increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day. - erythromycin lactobionate
erythromycin lactobionate increases levels of eszopiclone by enhancing GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
erythromycin lactobionate increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day. - erythromycin stearate
erythromycin stearate increases levels of eszopiclone by enhancing GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
erythromycin stearate increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day. - esketamine intranasal
esketamine intranasal, eszopiclone. Either increases toxicity of the other by sedation. Use Caution/Monitor.
- etravirine
etravirine will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- flibanserin
eszopiclone and flibanserin both increase sedation. Modify Therapy/Monitor Closely. Risk for sedation increased if flibanserin is coadministration with other CNS depressants.
- fosamprenavir
fosamprenavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- fosphenytoin
fosphenytoin will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- gabapentin
gabapentin, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.
- gabapentin enacarbil
gabapentin enacarbil, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.
- iloperidone
iloperidone increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- indinavir
indinavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- istradefylline
istradefylline will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- lasmiditan
lasmiditan, eszopiclone. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.
- lemborexant
eszopiclone, lemborexant. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.
- letermovir
letermovir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lopinavir
lopinavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- lorlatinib
lorlatinib will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lurasidone
lurasidone, eszopiclone. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.
- midazolam intranasal
midazolam intranasal, eszopiclone. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.
- nafcillin
nafcillin will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nelfinavir
nelfinavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- oliceridine
oliceridine, eszopiclone. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.
- phenytoin
phenytoin will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- pregabalin
pregabalin, eszopiclone. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.
- remimazolam
remimazolam, eszopiclone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.
- ribociclib
ribociclib will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifabutin
rifabutin will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifampin
rifampin will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. According to prescribing information, zopiclone AUC was decreased 80% by concomitant use of rifampin. A similar effect would be expected with eszopiclone (S-enantiomer of zopiclone).
- rifapentine
rifapentine will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ritonavir
ritonavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- rucaparib
rucaparib will increase the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- saquinavir
saquinavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- stiripentol
stiripentol, eszopiclone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
stiripentol, eszopiclone. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. - tazemetostat
tazemetostat will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- tipranavir
tipranavir increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
- voriconazole
voriconazole increases levels of eszopiclone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce eszopiclone starting dose to 1 mg/day.
Minor (0)
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%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Lunesta oral - | 3 mg tablet |  | |
| Lunesta oral - | 2 mg tablet |  | |
| Lunesta oral - | 1 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 3 mg tablet |  | |
| eszopiclone oral - | 2 mg tablet |  | |
| eszopiclone oral - | 1 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 persists after 7 to 10 days, or if it worsens.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 persist or worsen, 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 your doctor has prescribed this medication because he or she 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.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. 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.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 August 2019. Copyright(c) 2021 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.
Formulary
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