{ "query": "eszopiclone", "ingredient": "eszopiclone", "slug": "eszopiclone", "rxcui": "461016", "brands": [ "Lunesta" ], "names": [ "eszopiclone" ], "classes": [ { "id": "N05CF", "name": "Benzodiazepine related drugs" } ], "alternatives": [ "zaleplon", "zolpidem", "zopiclone" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 58, "OROPHARYNGEAL": 3 }, "boxed_warning": "WARNING: COMPLEX SLEEP BEHAVIORS WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: COMPLEX SLEEP BEHAVIOUR See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior ( 4 , 5.1 ).", "indications_and_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 ( 1 )", "contraindications": "\u2022 Eszopiclonetablet is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [see Warnings and Precautions (5.1) ]. \u2022 Eszopiclone tablet is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3) ]. \u2022 Patients who have experienced complex sleep behaviors after taking eszopiclone tablets ( 4 ) \u2022 Known hypersensitivity to eszopiclone ( 4 )", "warnings_and_cautions": "\u2022 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 ) \u2022 Evaluate for Comborbid Diagnoses Reevaluate if insomnia persists after 7 to 10 days of use ( 5.3 ) \u2022 Severe Anaphylactic/Anaphylactoid Reactions (angioedema and anaphylaxis have been reported): Do not rechallenge if such reactions occur ( 5.4 ) \u2022 Abnormal Thinking amd Behavioral Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported. Immediately evaluate any new onset of behavioral changes ( 5.5 ) \u2022 Worsening of Depression or Suicidal Thinking may occur: Prescribe the least number of tablets feasible to avoid intentional overdose ( 5.5 , 5.8 ) \u2022 Withdrawal Effects Symptoms may occur with rapid dose reduction or discontinuation ( 5.6 , 9.3 ) \u2022 Elderly Patients Use lower dose due to impaired motor, cognitive performance and increased sensitivity ( 2.2 , 5.8 ) \u2022 Patients with Hepatic Impairment, Impaired Respi...", "warnings": "", "adverse_reactions": "The following are described in more detail in the Warnings and Precautions section of the label: \u2022 Complex Sleep Behaviors [see Boxed Warning and Warnings and Precautions (5.1) ] \u2022 CNS Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2) ] \u2022 Need to Evaluate for Comorbid Diagnoses [see Warnings and Precautions (5.3) ] \u2022 Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions (5.4) ] \u2022 Abnormal Thinking and Behavioral Changes [see Warnings and Precautions (5.5) ] \u2022 Withdrawal Effects [see Warnings and Precautions (5.6) ] \u2022 Timing of Drug Administration [see Warnings and Precautions (5.7) ] \u2022 Special Populations [see Warnings and Precautions (5.8) ] 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...", "drug_abuse_and_dependence": "9.1 Controlled Substance Eszopiclone tablet is a Schedule IV controlled substance under the Controlled Substances Act. Other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. While eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines. 9.2 Abuse Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for nonmedical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug\u2019s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects. Addiction is a primary, chronic, neurobiologic...", "controlled_substance": "9.1 Controlled Substance Eszopiclone tablet is a Schedule IV controlled substance under the Controlled Substances Act. Other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. While eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines.", "recent_major_changes": "Boxed Warning 08/2019 Contraindications ( 4 ) 08/2019 Warnings and Precautions, Complex Sleep Behaviors ( 5.1 ) 08/2019 Warnings and Precautions, CNS Depressant Effects and Next-Day Impairment ( 5.2 ) 12/2018", "information_for_patients": "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 use...", "spl_medguide": "", "clinical_studies": "The effect of eszopiclone tablets on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18 to 86) with chronic and transient insomnia in six placebo-controlled trials of up to 6 months\u2019 duration. Two of these trials were in elderly patients (n=523). Overall, at the recommended adult dose (2 to 3 mg) and elderly dose (1 to 2 mg), eszopiclone tablets significantly decreased sleep latency and improved measures of sleep maintenance (objectively measured as wake time after sleep onset [WASO] and subjectively measured as total sleep time). 14.1 Transient Insomnia Healthy adults were evaluated in a model of transient insomnia (n=436) in a sleep laboratory in a double-blind, parallel-group, single-night trial comparing two doses of eszopiclone and placebo. Eszopiclone tablets 3 mg was superior to placebo on measures of sleep latency and sleep maintenance, including polysomnographic (PSG) parameters of latency to persistent sleep (LPS) and WASO. 14.2 Chronic Insomnia (Adults and Elderly) The effectiveness of eszopiclone tablets was established in five controlled studies in chronic insomnia. Three controlled studies were in adult subjec...", "brand_name": "Eszopiclone", "manufacturer": "Camber Pharmaceuticals, Inc.", "application_number": "ANDA205504", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20250220", "set_id": "00fc3250-3e29-4a4b-ac0c-74910659337c", "has_boxed_warning": true, "controlled": true, "mentions_rems": false }, "faers": { "total": 11937, "serious": 7059, "death": 1182, "hospitalization": 3218, "primary_suspect": 11923, "top_reactions": [ [ "Drug Ineffective", 1101 ], [ "Fatigue", 750 ], [ "Nausea", 723 ], [ "Insomnia", 719 ], [ "Headache", 548 ], [ "Pain", 489 ], [ "Off Label Use", 485 ], [ "Diarrhoea", 474 ], [ "Anxiety", 458 ], [ "Fall", 455 ], [ "Dizziness", 424 ], [ "Dyspnoea", 362 ], [ "Vomiting", 346 ], [ "Depression", 343 ], [ "Malaise", 340 ] ], "by_year": { "2019": 1171, "2020": 1073, "2021": 795, "2022": 820, "2023": 735, "2024": 823, "2025": 817, "2026": 388 }, "by_year_primary": { "2019": 1171, "2020": 1073, "2021": 793, "2022": 819, "2023": 731, "2024": 821, "2025": 814, "2026": 386 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20240604", "reason": "Failed Impurities/Degradation Specifications: Related Substances", "firm": "Dr. Reddy's Laboratories, Inc.", "status": "Ongoing" }, { "class": "Class II", "date": "20220616", "reason": "Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.", "firm": "Macleods Pharma Usa Inc", "status": "Terminated" } ], "recall_total": 2, "drugsfda": { "applications": 15, "nda": 1, "anda": 14, "first_approval": "20041215", "rems": false, "rems_last": "", "labeling_supplements": 10, "labeling_recent": 0, "sponsors": [ "AUROBINDO PHARMA", "CHARTWELL RX", "DR REDDYS", "GLENMARK PHARMS LTD", "HETERO LABS LTD V", "HIKMA", "IPCA LABS LTD", "LUPIN LTD" ], "unapproved": false, "first_approval_fmt": "12/15/2004" }, "trials": { "total": 76, "completed": 64, "terminated": 4, "with_results": 34, "industry": 48, "phase3": 17, "results_share": 0.53125, "terminated_share": 0.05263157894736842 }, "pubmed": { "rct": 41, "meta": 6, "recent_rct": 5, "cochrane": [ { "pmid": "30303519", "title": "Eszopiclone for insomnia", "year": "2018" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "eszopiclone", "Lunesta" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 843540, "beneficiaries": 187445, "spend": 24448973.14, "by_brand": [ { "brand": "Eszopiclone", "claims": 838132, "per_claim": 22.078691209, "is_generic": true }, { "brand": "Lunesta", "claims": 5408, "per_claim": 1099.133787, "is_generic": false } ], "per_claim": 28.98377449794912 }, "mdl": [], "dsc": [ { "date": "20140515", "title": "FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm397260.htm", "kind": "drug", "matched": "eszopiclone" } ], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 2021, "fills": 843540, "per_million": 2395.8555610877966, "ratio": 0.8652578681892251, "median": 2768.949753790441 }, "scores": { "safety": { "score": 52, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-8)", "2,396 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site", "Federally controlled substance: dependence and misuse risk (-10)", "Death share in reports is near or below the FAERS average (1.1x)" ], "weight": 0.35 }, "evidence": { "score": 46, "letter": "F", "why": [ "41 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed", "1 independent Cochrane review(s) exist", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 93, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 14 generic makers (-2)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (14 applications)", "3 same-class alternatives exist" ], "weight": 0.1 } }, "total": 69, "grade": "C", "questions": [ "In 2014 the FDA issued a safety communication about this drug (FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose). Does that risk apply to me?", "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "This is a controlled substance. What is the plan for how long I take it and how I stop?", "The most-reported problems in FDA's adverse event data are fatigue, nausea, insomnia. How would we recognize and handle those?", "Why this one over zaleplon, zolpidem, zopiclone? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }