Eszopiclone
Tablet, Film Coated · Oral, Oropharyngeal
Uses
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 have been shown to decrease sleep latency and improve sleep maintenance ( 1 ).
Dosage and administration
Use the lowest effective dose for the patient.
• Use the lowest dose effective for the patient ( 2 )
• 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 ( 2.1 )
• Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2 )
• Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg ( 2.3 )
• Do not take with or immediately after a meal ( 2.5 ) 2.1 Dosage 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 Warnings and Precautions ( 5.1 ) ]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions ( 5.6 ) ]. 2.2 Geriatric or Debilitated Patients The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients. 2.3 Patients 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 Warnings and Precautions ( 5.7 ) ]. 2.4 Use with CNS Depressants Dosage adjustments may be necessary when eszopiclone tablets are combined with other central nervous system (CNS) depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.1 ) ]. 2.5 Administration 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 Clinical Pharmacology ( 12.3 ) ].
Dosage forms and strengths
Eszopiclone Tablets, USP are available in 1 mg, 2 mg and 3 mg strengths for oral administration. Eszopiclone Tablets, USP, 3 mg are round, dark blue, film-coated tablets, debossed with ‘384’ on one side and ‘G’ on the other side. Eszopiclone Tablets, USP, 2 mg are round, white to off-white, film-coated tablets, debossed with ‘383’ on one side and ‘G’ on the other side. Eszopiclone Tablets, USP, 1 mg are round, light blue, film-coated tablets, debossed with ‘382’ on one side and ‘G’ on the other side. Tablets: 1 mg, 2 mg, and 3 mg ( 3 )
Contraindications
• Eszopiclone tablets are contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [see Warnings and Precautions ( 5.1 )] .
• Eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3 )].
• Patients who have experienced complex sleep behaviors after taking eszopiclone tablets ( 4 )
• Known hypersensitivity to eszopiclone ( 4 )
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. ( 5.2 )
• Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use ( 5.3 )
• Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur ( 5.4 )
• Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported. Immediately evaluate any new onset of behavioral changes ( 5.5 )
• Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose ( 5.5 , 5.8 )
• Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation ( 5.6 , 9.3 )
• Elderly Patients: Use lower dose due to impaired motor, cognitive performance and increased sensitivity ( 2.2 , 5.8 )
• Patients with Hepatic Impairment, Impaired Respiratory Function, Impaired Drug Metabolism or Hemodynamic Responses: Use with caution ( 5.8 ) 5.1 Complex Sleep Behaviors Complex sleep behaviors 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. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in fatal outcomes. 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 Drug Interactions ( 7.1 )]. Discontinue eszopiclone immediately if a patient experiences a complex sleep behavior . 5.2 CNS Depressant Effects and Next-Day Impairment Eszopiclone 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 may develop, patients using 3 mg eszopiclone 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 and concomitant CNS depressants should be considered [see Dosage and Administration ( 2.4 )]. The use of eszopiclone 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 is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants; or coadministered with other drugs that increase the blood levels of eszopiclone [see Dosage and Administration ( 2.3 ) and Clinical Studies ( 14.3 )]. Because eszopiclone can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls . 5.3 Need to Evaluate for Comorbid Diagnoses Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated . Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including eszopiclone. Because some of the important adverse effects of eszopiclone appear to be dose related, it is important to use the lowest possible effective dose, especially in the elderly [see Dosage and Administration ( 2.1 )] . 5.4 Severe Anaphylactic and Anaphylactoid Reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including eszopiclone. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with eszopiclone should not be rechallenged with the drug. 5.5 Abnormal Thinking and Behavioral Changes A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably.
Side effects
The following are described in more detail in the Warnings and Precautions section of the label:
• Complex Sleep Behaviors [see Boxed Warning and Warnings and Precautions ( 5.1 )] 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 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 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 ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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, and 1.4% of 72 patients who received 1 mg eszopiclone 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 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 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 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 1 Adverse Reaction Placebo (n=99) Eszopiclone 2 mg (n=104) Eszopiclone 3 mg (n=105) Body as a Whole Headache 13 21 17 Viral Infection 1 3 3 Digestive System Dry Mouth 3 5 7 Dyspepsia 4 4 5 Nausea 4 5 4 Vomiting 1 3 0 Nervous System Anxiety 0 3 1 Confusion 0 0 3 Depression 0 4 1 Dizziness 4 5 7 Hallucinations 0 1 3 Libido Decreased 0 0 3 Nervousness 3 5 0 Somnolence 3 10 8 Respiratory System Infection 3 5 10 Skin and Appendages Rash 1 3 4 Special Senses Unpleasant Taste 3 17 34 Urogenital System Dysmenorrhea * 0 3 0 Gynecomastia ** 0 3 0 1 Reactions for which the eszopiclone incidence was equal to or less than placebo are not listed on the table, but included the following: abnormal dreams, accidental injury, back pain, diarrhea, flu syndrome, myalgia, pain, pharyngitis, and rhinitis. * Gender-specific adverse reaction in females ** Gender-specific adverse reaction in males Adverse reactions from Table 1 that suggest a dose-response relationship in adults include viral infection, dry mouth, dizziness, hallucinations, infection, rash, and unpleasant taste, with this relationship clearest for unpleasant taste. Table 2 shows the incidence of adverse reactions from combined Phase 3 placebo-controlled studies of eszopiclone at doses of 1 or 2 mg in elderly adults (ages 65 to 86). Treatment duration in these trials was 14 days. The table includes only reactions that occurred in 2% or more of patients treated with eszopiclone 1 mg or 2 mg in which the incidence in patients treated with eszopiclone was greater than the incidence in placebo-treated patients. Table 2: Incidence (%) of Adverse Reactions in Elderly Adults (Ages 65 to 86 Years) in 2-Week Placebo-Controlled Trials with Eszopiclone 1 Adverse Reactions Placebo (n=208) Eszopiclone 1 mg (n=72) Eszopiclone 2 mg (n=215) Body as a Whole Accidental Injury 1 0 3 Headache 14 15 13 Pain 2 4 5 Digestive System Diarrhea 2 4 2 Dry Mouth 2 3 7 Dyspepsia 2 6 2 Nervous System Abnormal Dreams 0 3 1 Dizziness 2 1 6 Nervousness 1 0 2 Neuralgia 0 3 0 Skin and Appendages Pruritus 1 4 1 Special Senses Unpleasant Taste 0 8 12 Urogenital System Urinary Tract Infection 0 3 0 1 Reactions for which the eszopiclone incidence was equal to or less than placebo are not listed on the table, but included the following: abdominal pain, asthenia, nausea, rash, and somnolence. Adverse reactions from Table 2 that suggest a dose-response relationship in elderly adults include pain, dry mouth, and unpleasant taste, with this relationship again clearest for unpleasant taste.
Drug interactions
• CNS Depressants: Additive CNS-depressant effects with combination use. Use with ethanol causes additive psychomotor impairment ( 7.1 )
• Rifampicin: Combination use may decrease exposure and effects of eszopiclone ( 7.2 )
• Ketoconazole: Combination use increases exposure and effect of eszopiclone. Dose reduction of eszopiclone is needed ( 7.2 ) 7.1 CNS Active Drugs Ethanol: An additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol [see Warnings and Precautions ( 5.1 , 5.2 )] . 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. 7.2 Drugs 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 is needed for patients co administered eszopiclone with potent CYP3A4 inhibitors [see Dosage and Administration ( 2.3 )]. 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. Drug Interactions Eszopiclone is metabolized by CYP3A4 and CYP2E1 via demethylation and oxidation. There were no pharmacokinetic or pharmacodynamic interactions between eszopiclone and paroxetine. When eszopiclone was coadministered with olanzapine, no pharmacokinetic interaction was detected in levels of eszopiclone or olanzapine, but a pharmacodynamic interaction was seen on a measure of psychomotor function. Eszopiclone and lorazepam decreased each other’s C max by 22%. Coadministration of eszopiclone 3 mg to subjects receiving ketoconazole, a potent inhibitor of CYP3A4, 400 mg daily for 5 days, resulted in a 2.2-fold increase in exposure to eszopiclone. C max and t 1/2 were increased 1.4-fold and 1.3-fold, respectively. Eszopiclone would not be expected to alter the clearance of drugs metabolized by common CYP450 enzymes [see Warnings and Precautions ( 5.7 ), Dosage and Administration ( 2.3 )] . Paroxetine: Coadministration of single dose of eszopiclone and paroxetine produced no pharmacokinetic or pharmacodynamic interaction. The lack of a drug interaction following single-dose administration does not predict the complete absence of a pharmacodynamic effect following chronic administration. Lorazepam: Coadministration of single doses of eszopiclone and lorazepam did not have clinically relevant effects on the pharmacodynamics or pharmacokinetics of either drug. The lack of a drug interaction following single-dose administration does not predict the complete absence of a pharmacodynamic effect following chronic administration.
Use in specific populations
• Pediatric Use: Safety and effectiveness not established. Dizziness, dysgeusia, hallucinations, suicidal ideation reported ( 8.4 ) 8.1 Pregnancy 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 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. 8.2 Lactation 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. 8.4 Pediatric Use Safety and effectiveness of eszopiclone have not been established in pediatric patients. Eszopiclone 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 to 17 years) with insomnia associated with ADHD (with 65% of the patients using concomitant ADHD treatments) were treated with oral tablets of eszopiclone (1 or 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 doses ≥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. 8.5 Geriatric 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 Adverse Reactions ( 6 )] . Eszopiclone 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 the elderly patients [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] . 8.6 Hepatic Impairment No dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. Exposure was increased in severely impaired patients compared with healthy volunteers.
Pregnancy
8.1 Pregnancy 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 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
8.4 Pediatric Use Safety and effectiveness of eszopiclone have not been established in pediatric patients. Eszopiclone 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 to 17 years) with insomnia associated with ADHD (with 65% of the patients using concomitant ADHD treatments) were treated with oral tablets of eszopiclone (1 or 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 doses ≥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
8.5 Geriatric 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 Adverse Reactions ( 6 )] . Eszopiclone 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 the elderly patients [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] .
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 overdoses were reported only in combination with other CNS drugs or alcohol. 10.1 Signs 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. 10.2 Recommended 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.
Description
Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methylpiperazine-1-carboxylic acid 6-(5-chloro-2-pyridyl)-7-oxo-6, 7-dihydro-5 H-pyrrolo [3,4-b]pyrazin-5(S)-yl ester. Its molecular weight is 388.81 g/mol, and its empirical 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 is a white to light yellow powder. Eszopiclone is slightly soluble in acetone, methanol and alcohol; practically insoluble in water. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, 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. eszopiclone-chemical-structure
Mechanism of action
12.1 Mechanism 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
Eszopiclone Tablets, USP, 3 mg are round, dark blue, film-coated, and identified with debossed markings of ‘384’ on one side, and ‘G’ on the other side and are supplied as: NDC 68462-384-30 bottle of 30 tablets NDC 68462-384-01 bottle of 100 tablets NDC 68462-384-10 bottle of 1000 tablets Eszopiclone Tablets, USP, 2 mg are round, white to off-white, film-coated, and identified with debossed markings of ‘383’ on one side, and ‘G’ on the other side and are supplied as: NDC 68462-383-01 bottle of 100 tablets NDC 68462-383-10 bottle of 1000 tablets Eszopiclone Tablets, USP, 1 mg are round, light blue, film-coated, and identified with debossed markings of ‘382’ on one side, and ‘G’ on the other side and are supplied as: NDC 68462-382-30 bottle of 30 tablets NDC 68462-382-01 bottle of 100 tablets NDC 68462-382-10 bottle of 1000 tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°F to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Patient information
See FDA-approved patient labeling (Medication Guide). 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, Warnings and Precautions ( 5.1 )]. 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 Warnings and Precautions ( 5.2 )]. Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with eszopiclone tablets Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions ( 5.4 )] . 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. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2025 logo1
Label text from the FDA structured product label by Glenmark Pharmaceuticals Inc. USA (revised Jan 30, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Eszopiclone in 90 products
Eszopiclone NDC products (90)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7745 | Eszopiclone 2 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-7744 | Eszopiclone 1 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-3514 | Eszopiclone 3 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-7746 | Eszopiclone 3 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 80425-0067 | Eszopiclone 3 mg/1 Tablet, Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0098 | Eszopiclone 1 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0066 | Eszopiclone 3 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0065 | Eszopiclone 3 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0064 | Eszopiclone 2 mg/1 Tablet, Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0063 | Eszopiclone 2 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0062 | Eszopiclone 2 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0407 | Eszopiclone 1 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0168 | Eszopiclone 1 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0115 | Eszopiclone 3 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 71610-409 | Eszopiclone 3 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 76420-354 | Eszopiclone 3 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-353 | Eszopiclone 2 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-352 | Eszopiclone 1 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-027 | Eszopiclone 3 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-026 | Eszopiclone 1 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-024 | Eszopiclone 2 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 65862-968 | Eszopiclone 2 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 65862-969 | Eszopiclone 3 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 65862-967 | Eszopiclone 1 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 69452-349 | Eszopiclone 3 mg/1 Tablet, Film Coated | Bionpharma Inc. | ANDA · DEA CIV |
| 69452-348 | Eszopiclone 2 mg/1 Tablet, Film Coated | Bionpharma Inc. | ANDA · DEA CIV |
| 69452-347 | Eszopiclone 1 mg/1 Tablet, Film Coated | Bionpharma Inc. | ANDA · DEA CIV |
| 71335-0089 | Eszopiclone 2 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0116 | Eszopiclone 3 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0512 | Eszopiclone 2 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0574 | Eszopiclone 1 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0598 | Eszopiclone 1 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2002 | Eszopiclone 3 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2698 | Eszopiclone 2 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-9659 | Eszopiclone 1 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 31722-857 | Eszopiclone 3 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 31722-856 | Eszopiclone 2 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 31722-855 | Eszopiclone 1 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72189-099 | Eszopiclone 1 mg/1 Tablet, Film Coated | DIRECT RX | ANDA · DEA CIV |
| 61919-033 | Eszopiclone 2 mg/1 Tablet, Film Coated | DIRECT RX | ANDA · DEA CIV |
| 55111-617 | Eszopiclone 3 mg/1 Tablet, Coated | Dr. Reddy's Laboratories Limited | ANDA · DEA CIV |
| 55111-619 | Eszopiclone 2 mg/1 Tablet, Coated | Dr. Reddy's Laboratories Limited | ANDA · DEA CIV |
| 55111-629 | Eszopiclone 1 mg/1 Tablet, Coated | Dr. Reddy's Laboratories Limited | ANDA · DEA CIV |
| 68462-382 | Eszopiclone 1 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc. USA | ANDA · DEA CIV |
| 68462-383 | Eszopiclone 2 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc. USA | ANDA · DEA CIV |
| 68462-384 | Eszopiclone 3 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc. USA | ANDA · DEA CIV |
| 60429-632 | Eszopiclone 1 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 60429-633 | Eszopiclone 2 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 60429-634 | Eszopiclone 3 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 68180-324 | Eszopiclone 3 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68180-322 | Eszopiclone 1 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68180-323 | Eszopiclone 2 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 33342-299 | Eszopiclone 1 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA · DEA CIV |
| 33342-301 | Eszopiclone 3 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA · DEA CIV |
| 33342-300 | Eszopiclone 2 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA · DEA CIV |
| 0378-5270 | Eszopiclone 1 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA · DEA CIV |
| 0378-5272 | Eszopiclone 3 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA · DEA CIV |
| 0378-5271 | Eszopiclone 2 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68071-2403 | Eszopiclone 3 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-3376 | Eszopiclone 3 mg/1 Tablet, Film Coated | NuCarePharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-067 | Eszopiclone 3 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 43063-795 | Eszopiclone 3 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68788-8826 | Eszopiclone 1 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-8387 | Eszopiclone 1 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-7169 | Eszopiclone 3 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-7029 | Eszopiclone 2 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-7667 | Eszopiclone 1 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 82804-076 | Eszopiclone 2 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 82804-159 | Eszopiclone 1 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 71205-581 | Eszopiclone 1 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 63187-817 | Eszopiclone 1 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 63187-843 | Eszopiclone 3 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 63187-970 | Eszopiclone 2 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 71205-384 | Eszopiclone 1 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 71205-513 | Eszopiclone 2 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 71205-633 | Eszopiclone 3 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 71205-236 | Eszopiclone 3 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 55700-610 | Eszopiclone 3 mg/1 Tablet, Film Coated | Quality Care Products LLC | ANDA · DEA CIV |
| 55700-581 | Eszopiclone 2 mg/1 Tablet, Film Coated | Quality Care Products LLC | ANDA · DEA CIV |
| 70518-4398 | Eszopiclone 2 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-4361 | Eszopiclone 2 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3576 | Eszopiclone 3 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-1310 | Eszopiclone 2 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA · DEA CIV |
| 60760-526 | Eszopiclone 2 mg/1 Tablet, Film Coated | St Mary's Medical Park Pharmacy | ANDA · DEA CIV |
| 47335-588 | Eszopiclone 3 mg/1 Tablet, Film Coated | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIV |
| 47335-587 | Eszopiclone 2 mg/1 Tablet, Film Coated | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIV |
| 47335-586 | Eszopiclone 1 mg/1 Tablet, Film Coated | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIV |
| 0093-5539 | Eszopiclone 3 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 0093-5538 | Eszopiclone 2 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
| 0093-5537 | Eszopiclone 1 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CIV |
Eszopiclone recalls
- D-0581-2024 Jul 10, 2024 · Class III · Ongoing
Failed Impurities/Degradation Specifications: Related Substances - D-1174-2022 Jul 13, 2022 · Class II · Terminated
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Frequently asked questions
What is Eszopiclone used for?
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…
What are the side effects of Eszopiclone?
The following are described in more detail in the Warnings and Precautions section of the label: • Complex Sleep Behaviors [see Boxed Warning and Warnings and Precautions ( 5.1 )] 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… See the full label for the complete list.
Who makes Eszopiclone?
Eszopiclone is listed by 27 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC, Aphena Pharma Solutions - Tennessee, LLC.
Has Eszopiclone been recalled?
The FDA enforcement database lists 2 recalls for Eszopiclone, most recently D-0581-2024 (class iii): Failed Impurities/Degradation Specifications: Related Substances