Eszopiclone 1 mg Tablet, Film Coated, 30-count
Other active recalls for Eszopiclone (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Benzodiazepine related drugs class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Eszopiclone helps you fall asleep faster and stay asleep longer, and it's been studied for up to 6 months in adults. It treats the symptoms of insomnia rather than the underlying c...
- What exactly does eszopiclone do — will it just make me sleepy, or does it actually fix my insomnia?
- Eszopiclone is a federally controlled substance (Schedule IV) because it can be habit-forming with long-term use. Your doctor will prescribe the lowest effective dose for the short...
- Is it safe to take eszopiclone every night, or is it habit-forming?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Eszopiclone — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1735 | $5.21 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Eszopiclone 1 mg 00093-5537-56 | Teva | 30 tablets | $0.091 | AB | Availability likely | — |
| Eszopiclone 1 mg 00378-5270-01 | Mylan | 100 tablets | $0.091 | AB | Availability likely | — |
| Eszopiclone 1 mg 31722-0855-01 | Camber | 100 tablets | $0.091 | AB | Availability likely | — |
| Eszopiclone 1 mg 33342-0299-07 | Macleods | 30 tablets | $0.091 | AB | Availability likely | — |
| Eszopiclone 1 mg 65862-0967-01 | Aurobindo | 100 tablets | $0.091 | — | Availability likely | — |
| Eszopiclone 1 mg 68462-0382-01 | Glenmark | 100 tablets | $0.091 | AB | Availability likely | — |
| Eszopiclone 1 mg 69452-0347-13 | Bionpharma | 30 tablets | $0.091 | AB | Availability likely | — |
| Eszopiclone 1 mg 68180-0322-01 | Lupin | 100 tablets | $0.145 | — | FDA listed | — |
| Eszopiclone 1 mg 47335-0586-08 | Sun | 100 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 50090-7744-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 55111-0629-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 55700-0621-30 | Lake | 30 tablets | — | AB | Discontinued | — |
| Eszopiclone 1 mg 60429-0632-01 | Golden | 100 tablets | — | AB | Discontinued | — |
| Eszopiclone 1 mg 63187-0817-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 68788-7667-00 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 68788-8387-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 68788-8826-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 71205-0384-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 71205-0581-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 71335-0574-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 71335-0598-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 71335-9659-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 72189-0099-30 | DIRECT | 30 tablets | — | — | FDA listed | — |
| Eszopiclone 1 mg 76420-0026-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 76420-0352-00 | Asclemed | 1000 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 80425-0098-01 | Advanced | 60 tablets | — | — | FDA listed | — |
| Eszopiclone 1 mg 80425-0168-02 | Advanced | 60 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mg 80425-0407-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Lunesta 1 mg 80725-0010-30 | Waylis | 30 tablets | — | AB | FDA listed | — |
| Eszopiclone 1 mgthis 82804-0159-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82804-0159-30 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (82804-159-30) | 2026-02-06 | Active |
| 82804-0159-60 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-159-60) | 2025-03-12 | Active |
| 82804-0159-90 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-159-90) | 2024-10-11 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 82804-0159-30?
What is the difference between NDC 82804-0159-30 and NDC 82804-0159-60?
What NDC number is used to bill for this package of Eszopiclone 1 mg Tablet, Film Coated?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration.
The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets has been shown to decrease sleep latency and improve sleep maintenance ( Error!
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⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Use the lowest effective dose for the patient. • Use the lowest dose effective for the patient ( ) • Recommended initial dose is 1 mg, immediately before bedtime, with at least 7 to 8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg ( Error! Hyperlink reference not valid. ) • Geriatric or debilitated patients: Dose should not exceed 2 mg ( Error!
Hyperlink reference not valid. ) • Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg ( Error! Hyperlink reference not valid. ) • Do not take with or immediately after a meal ( Error! Hyperlink reference not valid. )
2.1Dosage in Adults The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [ see Error!
Hyperlink reference not valid. ]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [ see Error! Hyperlink reference not valid. ].
2.2Geriatric or Debilitated Patients The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [ see Error! Hyperlink reference not valid. ].
2.4Use with CNS Depressants Dosage adjustments may be necessary when eszopiclone tablets are combined with othercentral nervous system (CNS) depressant drugs because of the potentially additive effects [ see Error! Hyperlink reference not valid. ].
2.5Administration with Food Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Error! Hyperlink reference not valid. ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Eszopiclone tablets, USP are available in 1 mg, 2 mg and 3 mg strengths for oral administration. Eszopiclone tablets USP, 3 mg are dark blue to blue, round, biconvex, film-coated tablets debossed with ‘H’ on one side and ‘E16’ on the other side. Eszopiclone tablets USP, 2 mg are white to off-white, round, biconvex, film-coated tablets debossed with ‘H’ on one side and ‘E15’ on the other side.
Eszopiclone tablets USP, 1 mg are light blue, round, biconvex, film-coated tablets debossed with ‘H’ on one side and ‘E14’ on the other side. Tablets: 1 mg, 2 mg, and 3 mg ( Error! Hyperlink reference not valid. )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Eszopiclonetablet is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [see Error! Hyperlink reference not valid. ]. • Eszopiclone tablet is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Error!
Hyperlink reference not valid. ]. • Patients who have experienced complex sleep behaviors after taking eszopiclone tablets ( Error! Hyperlink reference not valid. ) • Known hypersensitivity to eszopiclone ( Error! Hyperlink reference not valid. )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • CNS Depressant Effects Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients taking 3 mg dose against driving and against activities requiring complete mental alertness during the morning after use.
( Error! Hyperlink reference not valid. ) • Evaluate for Comborbid Diagnoses Reevaluate if insomnia persists after 7 to 10 days of use ( Error! Hyperlink reference not valid. ) • Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur ( Error!
Hyperlink reference not valid. ) • Abnormal Thinking amd Behavioral Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported. Immediately evaluate any new onset of behavioral changes ( Error! Hyperlink reference not valid. ) • Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose ( Error!
Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • Withdrawal Effects Symptoms may occur with rapid dose reduction or discontinuation ( Error! Hyperlink reference not valid. , Error!
Hyperlink reference not valid. ) • Elderly Patients Use lower dose due to impaired motor, cognitive performance and increased sensitivity ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • Patients with Hepatic Impairment, Impaired Respiratory Function, Impaired Drug Metabolism or Hemodynamic Responses Use with caution ( Error!
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5.1Complex Sleep Behaviours Complex sleepbehaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of eszopiclone tablet. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome.
Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Post-marketing reports have shown that complex sleep behaviors may occur with eszopiclone alone at recommended dosages, with or without the concomitant use of alcohol or other CNS depressants [see Error!
Hyperlink reference not valid. ]. Discontinue eszopiclone immediately if a patient experiences a complex sleep behavior.
5.2CNS Depressant Effects and Next-Day Impairment Eszopiclone tablet is a CNS depressant and can impair daytime function in some patients at the higher doses (2 mg or 3 mg), even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of symptoms (or even with subjective improvement), and impairment may not be reliably detected by ordinary clinical exam (i.e., less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of eszopiclone tablets may develop, patients using 3 mg eszopiclone tablets should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.
Additive effects occur with concomitant use of other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of eszopiclone tablets and concomitant CNS depressants should be considered [see Error! Hyperlink reference not valid. ].
The use of eszopiclone tablets with other sedative-hypnotics at bedtime or the middle of the night is not recommended. The risk of next-day psychomotor impairment is increased if eszopiclone tablets are taken with less than a full night of sleep remaining (7- to 8 hours); if higher than the recommended dose is taken; if co-administered with other CNS depressants; or coadminis…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are described in more detail in the section of the label: • Complex Sleep Behaviors [see Boxed Warning and Error! Hyperlink reference not valid. ] • CNS Depressant Effects and Next-Day Impairment [see Error! Hyperlink reference not valid. ] • Need to Evaluate for Comorbid Diagnoses [see Error!
Hyperlink reference not valid. ] • Severe Anaphylactic and Anaphylactoid Reactions [see Error! Hyperlink reference not valid. ] • Abnormal Thinking and Behavioral Changes [see Error! Hyperlink reference not valid. ] • Withdrawal Effects [see Error!
Hyperlink reference not valid. ] • Timing of Drug Administration [see Error! Hyperlink reference not valid. ] • Special Populations [see Error! Hyperlink reference not valid. ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The premarketing development program for eszopiclone tablets included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. The conditions and duration of treatment with eszopiclone tablets varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure.
Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.
Most commonly observed adverse reactions (incidence ≥2%) were unpleasant taste, headache, somnolence, respiratory infection, dizziness, dry mouth, rash, anxiety, hallucinations, and viral infections ( Error! Hyperlink reference not valid. ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or ww.fda.gov/medwatch.
6.1Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment In placebo-controlled, parallel-group clinical trials in the elderly, 3.8% of 208 patients who received placebo, 2.3% of 215 patients who received 2 mg eszopiclone tablets, and 1.4% of 72 patients who received 1 mg eszopiclone tablets discontinued treatment due to an adverse reaction. In the 6-week parallel-group study in adults, no patients in the 3 mg arm discontinued because of an adverse reaction. In the long-term 6-month study in adult insomnia patients, 7.2% of 195 patients who received placebo and 12.8% of 593 patients who received 3 mg eszopiclone tablets discontinued due to an adverse reaction.
No reaction that resulted in discontinuation occurred at a rate of greater than 2%. Adverse Reactions Observed at an Incidence of ≥2% in Controlled Trials Table 1 shows the incidence of adverse reactions from a Phase 3 placebo-controlled study of eszopiclone tablets at doses of 2 or 3 mg in nonelderly adults. Treatment duration in this trial was 44 days.
The table includes only reactions that occurred in 2% or more of patients treated with eszopiclone tablets 2 mg or 3 mg in which the incidence in patients treated with eszopiclone was greater than the incidence in placebo-treated patients. Table 1: Incidence (%) of Adverse Reactions in a 6-Week Placebo-Controlled Study in Nonelderly Adults with Eszopiclone Tablets 1 Adverse Reaction Placebo (n=99) Eszopiclone tablets 2 mg (n=104…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • CNS Depressants Additive CNS-depressant effects with combination use. Use with ethanol causes additive psychomotor impairment ( Error! Hyperlink reference not valid. ) • Rifampicin Combination use may decrease exposure and effects of eszopiclone tablets ( Error!
Hyperlink reference not valid. ) • Ketoconazole Combination use increases exposure and effect of eszopiclone tablets. Dose reduction of eszopiclone tablet is needed ( Error! Hyperlink reference not valid. )
7.1CNS Active Drugs Ethanol: An additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ]. Olanzapine: Coadministration of eszopiclone and olanzapine produced a decrease in DSST scores. The interaction was pharmacodynamic; there was no alteration in the pharmacokinetics of either drug.
7.2Drugs that Inhibit or Induce CYP3A4 Drugs that Inhibit CYP3A4 (Ketoconazole) CYP3A4 is a major metabolic pathway for elimination of eszopiclone. The exposure of eszopiclone was increased by coadministration of ketoconazole, a potent inhibitor of CYP3A4. Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly.
Dose reduction of eszopiclone tablet is needed for patient co-administered eszopiclone tablets with potent CYP3A4 inhibitors [see Error! Hyperlink reference not valid. ] . Drugs that Induce CYP3A4 (Rifampicin) Racemic zopiclone exposure was decreased 80% by concomitant use of rifampicin, a potent inducer of CYP3A4.
A similar effect would be expected with eszopiclone. Combination use with CYP3A4 inducer may decrease the exposure and effects of eszopiclone tablets.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pediatric Use Safety and effectiveness not established. Dizziness, dysgeusia, hallucinations, suicidal ideation reported ( Error! Hyperlink reference not valid. )
8.1Pregnancy Risk Summary Available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. Administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose was approximately 200 times the maximum recommended human dose (MRHD) of 3 mg/day based on mg/m 2 body surface area (See Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) throughout organogenesis showed no evidence of teratogenicity up to the highest doses tested. In rats, reduced fetal weight and increased incidences of skeletal variations and/or delayed ossification were observed at the mid and high doses. The no-observed-effect dose for adverse effects on embryofetal development is 200 times the maximum recommended human dose (MRHD) of 3 mg/day on a mg/m 2 basis.
No effects on embryofetal development were observed in rabbits; the highest dose tested is approximately 100 times the MRHD on a mg/m 2 basis. Oral administration of eszopiclone (60, 120, or 180 mg/kg/day) to pregnant rats throughout the pregnancy and lactation resulted in increased post-implantation loss, decreased postnatal pup weights and survival, and increased pup startle response at all doses. The lowest dose tested is approximately 200 times the MRHD on a mg/m 2 basis.
Eszopiclone had no effects on other developmental measures or reproductive function in the offspring.
8.2Lactation Risk Summary There are no data on the presence of eszopiclone in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for eszopiclone and any potential adverse effects on the breastfed infant from eszopiclone or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness of eszopiclone tablets have not been established in pediatric patients. Eszopiclone tablets failed to demonstrate efficacy in controlled clinical studies of pediatric patients with Attention-Deficit/Hyperactivity (ADHD) associated insomnia. In a 12–week controlled study, 483 pediatric patients (aged 6 to17 years) with insomnia associated with ADHD (with 65% of the patients using concomitant ADHD treatments) were treated with oral tablets of eszopiclone (1, 2 or 3 mg tablets, n=323), or placebo (n=160).
Eszopiclone did not significantly decrease latency to persistent sleep, compared to placebo, as measured by polysomnography after 12 weeks of treatment. Psychiatric and nervous system disorders comprised the most frequent treatment-emergent adverse reactions observed with eszopiclone versus placebo and included dysgeusia (9% vs.1%), dizziness (6% vs. 2%), hallucinations (2% vs.
0%) and suicidal ideation (0.3% vs. 0%). Nine patients on eszopiclone (3%) discontinued treatment due to an adverse reaction compared to 3 patients on placebo (2%).
In studies in which eszopiclone (2 to 300 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, neurobehavioral imp…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. Administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose was approximately 200 times the maximum recommended human dose (MRHD) of 3 mg/day based on mg/m 2 body surface area (See Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) throughout organogenesis showed no evidence of teratogenicity up to the highest doses tested. In rats, reduced fetal weight and increased incidences of skeletal variations and/or delayed ossification were observed at the mid and high doses. The no-observed-effect dose for adverse effects on embryofetal development is 200 times the maximum recommended human dose (MRHD) of 3 mg/day on a mg/m 2 basis.
No effects on embryofetal development were observed in rabbits; the highest dose tested is approximately 100 times the MRHD on a mg/m 2 basis. Oral administration of eszopiclone (60, 120, or 180 mg/kg/day) to pregnant rats throughout the pregnancy and lactation resulted in increased post-implantation loss, decreased postnatal pup weights and survival, and increased pup startle response at all doses. The lowest dose tested is approximately 200 times the MRHD on a mg/m 2 basis.
Eszopiclone had no effects on other developmental measures or reproductive function in the offspring.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of eszopiclone tablets have not been established in pediatric patients. Eszopiclone tablets failed to demonstrate efficacy in controlled clinical studies of pediatric patients with Attention-Deficit/Hyperactivity (ADHD) associated insomnia. In a 12–week controlled study, 483 pediatric patients (aged 6 to17 years) with insomnia associated with ADHD (with 65% of the patients using concomitant ADHD treatments) were treated with oral tablets of eszopiclone (1, 2 or 3 mg tablets, n=323), or placebo (n=160).
Eszopiclone did not significantly decrease latency to persistent sleep, compared to placebo, as measured by polysomnography after 12 weeks of treatment. Psychiatric and nervous system disorders comprised the most frequent treatment-emergent adverse reactions observed with eszopiclone versus placebo and included dysgeusia (9% vs.1%), dizziness (6% vs. 2%), hallucinations (2% vs.
0%) and suicidal ideation (0.3% vs. 0%). Nine patients on eszopiclone (3%) discontinued treatment due to an adverse reaction compared to 3 patients on placebo (2%).
In studies in which eszopiclone (2 to 300 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, neurobehavioral impairment (altered auditory startle response) and reproductive toxicity (adverse effects on male reproductive organ weights and histopathology) were observed at doses ≥5 mg/kg/day. Delayed sexual maturation was noted in males and females at ≥10 mg/kg/day. The no-effect dose (2 mg/kg) was associated with plasma exposures (AUC) for eszopiclone and metabolite (S)-desmethylzopiclone [(S)-DMZ] approximately 2 times plasma exposures in humans at the MRHD in adults (3 mg/day).
When eszopiclone (doses from 1 to 50 mg/kg/day) was orally administered to young dogs from weaning through sexual maturity, neurotoxicity (convulsions) was observed at doses ≥ 5 mg/kg/day. Hepatotoxicity (elevated liver enzymes and hepatocellular vacuolation and degeneration) and reproductive toxicity (adverse effects on male reproductive organ weights and histopathology) were noted at dose ≥10 mg/kg/day. The no-effect dose (1 mg/kg) was associated with plasma exposures (AUC) to eszopiclone and (S)-DMZ approximately 3 and 2 times, respectively, plasma exposures in humans at the MRHD in adults.
🧓 Geriatric Use ▾
8.5Geriatric Use A total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age. The overall pattern of adverse events for elderly subjects (median age = 71 years) in 2-week studies with nighttime dosing of 2 mg eszopiclone was not different from that seen in younger adults [see ]. Eszopiclone tablets 2 mg exhibited significant reduction in sleep latency and improvement in sleep maintenance in the elderly population.
Compared with nonelderly adults, subjects 65 years and older had longer elimination and higher total exposure to eszopiclone. Therefore, dose reduction is recommended in elderly patients [see Error! Hyperlink reference not valid. , Error!
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🆘 Overdosage ▾
10 OVERDOSAGE 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 eszopiclone tablets overdoses were reported only in combination with other CNS drugs or alcohol.
10.1Signs 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.
Methemoglobinemia in association with overdoses of racemic zopiclone has been reported.
10.2Recommended 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. Consider monitoring methemoglobin in the setting of high-dose overdosage.
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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of eszopiclone as a hypnotic is unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.
12.3Pharmacokinetics The pharmacokinetics of eszopiclone have been investigated in healthy subjects (adult and elderly) and in patients with hepatic disease or renal disease. In healthy subjects, the pharmacokinetic profile was examined after single doses of up to 7.5 mg and after once-daily administration of 1, 3, and 6 mg for 7 days. Eszopiclone is rapidly absorbed, with a time to peak concentration (t max) of approximately 1 hour and a terminal-phase elimination half-life (t 1/2 ) of approximately 6 hours.
In healthy adults, eszopiclone tablets does not accumulate with once-daily administration, and its exposure is dose-proportional over the range of 1 to 6 mg. Absorption and Distribution Eszopiclone is rapidly absorbed following oral administration. Peak plasma concentrations are achieved within approximately 1 hour after oral administration.
Eszopiclone is weakly bound to plasma protein (52 to 59%). The large free fraction suggests that eszopiclone disposition should not be affected by drug-drug interactions caused by protein binding. The blood-to-plasma ratio for eszopiclone is less than one, indicating no selective uptake by red blood cells.
Metabolism Following oral administration, eszopiclone is extensively metabolized by oxidation and demethylation. The primary plasma metabolites are ( S )-zopiclone-N-oxide and ( S )-N-desmethyl zopiclone; the latter compound binds to GABA receptors with substantially lower potency than eszopiclone, and the former compound shows no significant binding to this receptor. In vitro studies have shown that CYP3A4 and CYP2E1 enzymes are involved in the metabolism of eszopiclone.
Eszopiclone did not show any inhibitory potential on CYP450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 in cryopreserved human hepatocytes. Elimination After oral administration, eszopiclone is eliminated with a mean t 1/2 of approximately 6 hours. Up to 75% of an oral dose of racemic zopiclone is excreted in the urine, primarily as metabolites.
A similar excretion profile would be expected for eszopiclone, the S-isomer of racemic zopiclone. Less than 10% of the orally administered eszopiclone dose is excreted in the urine as parent drug. Effect of Food In healthy adults, administration of a 3 mg dose of eszopiclone after a high-fat meal resulted in no change in AUC, a reduction in mean C max of 21%, and delayed t max by approximately 1 hour.
The half-life remained unchanged, approximately 6 hours. The effects of eszopiclone tablets on sleep onset may be reduced if it is taken with or immediately after a high-fat/heavy meal. Specific Populations Age Compared with nonelderly adults, subjects 65 years and older had an increase of 41% in total exposure (AUC) and a slightly prolonged elimination of eszopiclone (t 1/2 approximately 9 hours).
C max was unchanged. Therefore, in elderly patients the dose should not exceed 2 mg. Gender The pharmacokinetics of eszopiclone in men and women are similar.
Race In an analysis of data on all subjects participating in Phase 1 studies of eszopiclone, the pharmacokinetics for all races studied appeared similar. Hepatic Impairment Pharmacokinetics of a 2 mg eszopiclone dose were assessed in 16 healthy volunteers and in 8 subjects with mild, moderate, and severe liver disease. Exposure was increased 2-fold in severely impaired patients compared with the healthy volunteers.
C max and t max were unchanged. No dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. Dose reduction is recommended for patients with severe hepatic impairment.
Eszopiclone tablets should be used with caution in patients with hepatic impairment [see Error! Hyperlink reference not valid. ]. Renal Impairm…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of eszopiclone as a hypnotic is unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING NDC 82804-159-90 Eszopiclone tablets USP, 1 mg are light blue, round, biconvex, film-coated tablets debossed with ‘H’ on one side and ‘E14’ on the other side. Bottles of 30 tablets NDC 82804-159-30 Bottles of 60 tablets NDC 82804-159-60 Bottles of 90 tablets NDC 82804-159-90 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Eszopiclone is a hypnotic agent/nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methyl-1-piperazinecarboxylic acid 6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5 H pyrrolo[3,4- b ]pyrazin-5-(S)-yl ester. Its molecular weight is 388.81, and its molecular formula is C 17 H 17 ClN 6 O 3 .
Eszopiclone has a single chiral center with an ( S )-configuration. It has the following chemical structure: Eszopiclone USP is a white to slight yellowish powder. Eszopiclone USP is soluble in methylene chloride and dilute hydrochloric acid; practically insoluble in water and in alcohol.
Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, hypromellose lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2/indigo carmine aluminium lake. eszopiclonestructure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Error! Hyperlink reference not valid. ). Inform patients and their families about the benefits and risks of treatment with eszopiclone tablets.
Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with eszopiclone tablets and with each prescription refill. Review the eszopiclone tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that eszopiclone tablets should be taken only as prescribed.
Complex Sleep Behaviors Instruct patients and their families that ESZOPICLONE TABLETS may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue ESZOPICLONE TABLETS and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning , Error!
Hyperlink reference not valid. ]. CNS Depressant Effects and Next-Day Impairment Tell patients that eszopiclone tablets can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients taking the 3 mg dose against driving and other activities requiring complete mental alertness the day after use.
Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Error! Hyperlink reference not valid. ].
Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with eszopiclone. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Error! Hyperlink reference not valid. ].
Suicide Tell patients to immediately report any suicidal thoughts. Alcohol and Other Drugs Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use eszopiclone tablets if they drank alcohol that evening or before bed.
Tolerance, Abuse, and Dependence Tell patients not to increase the dose of eszopiclone tablets on their own, and to inform you if they believe the drug "does not work.” Administration Instructions Patients should be counseled to take eszopiclone tablets right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again. Eszopiclone tablets should not be taken with or immediately after a meal. Advise patients NOT to take eszopiclone tablets if they drank alcohol that evening.
Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd.
Sangareddy - 502313, Telangana, India. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 01/2023 eszopiclonecamberlogo