{ "query": "clonazepam", "ingredient": "clonazepam", "slug": "clonazepam", "rxcui": "2598", "brands": [ "Klonopin" ], "names": [ "clonazepam" ], "classes": [ { "id": "N03AE", "name": "Benzodiazepine derivatives" } ], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 94 }, "boxed_warning": "WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including Klonopin, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Klonopin and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ) . The continued use of benzodiazepines, including Klonopin, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher...", "indications_and_usage": "INDICATIONS AND USAGE Seizure Disorders Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder Klonopin is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Klonopin was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials ). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abrup...", "contraindications": "CONTRAINDICATIONS Klonopin is contraindicated in patients with the following conditions: History of sensitivity to benzodiazepines Clinical or biochemical evidence of significant liver disease Acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy).", "warnings_and_cautions": "", "warnings": "WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Klonopin, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Klonopin concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Klonopin is used with opioids (see PRECAUTIONS: Information for Patients and PRECAUTIONS: Drug Interactions ). Abuse, Misuse, and Addiction The use of benzodiazepines, including KLONOPIN, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but n...", "adverse_reactions": "ADVERSE REACTIONS The adverse experiences for Klonopin are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders The most frequently occurring side effects of Klonopin are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Others, listed by system, including those identified during postapproval use of Klonopin are: Cardiovascular: Palpitations Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema Gastrointestinal: Anorexia, coated tongue, constipation, diarrhea, dry mouth, encopresis, gastritis, increased appetite, nausea, sore gums Genitourinary: Dysuria, enuresis, nocturia, urinary retention Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase Musculoskeletal: Muscle weakness, pains Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain Neurologic: A...", "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Controlled Substance Klonopin contains clonazepam, a Schedule IV controlled substance. Abuse Klonopin is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of ...", "controlled_substance": "Controlled Substance Klonopin contains clonazepam, a Schedule IV controlled substance.", "recent_major_changes": "", "information_for_patients": "Information for Patients A Klonopin Medication Guide must be given to the patient each time Klonopin is dispensed, as required by law. Patients should be instructed to take Klonopin only as prescribed. Physicians are advised to discuss the following issues with patients for whom they prescribe Klonopin: Risks from Concomitant Use with Opioids Inform patients and caregivers that potentially fatal additive effects may occur if Klonopin is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider (see WARNINGS: Risks from Concomitant Use with Opioids and PRECAUTIONS: Drug Interactions ). Abuse, Misuse, and Addiction Inform patients that the use of KLONOPIN, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances . Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS: Abuse, Misuse, and Addiction an...", "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 1/2023 MEDICATION GUIDE KLONOPIN (KLON-oh-pin) (clonazepam) tablets, for oral use, CIV What is the most important information I should know about KLONOPIN? KLONOPIN is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking KLONOPIN and opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including KLONOPIN, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including KLONOPIN. These serious side effects may also include delirium, paranoia, suicidal th...", "clinical_studies": "", "brand_name": "Klonopin", "manufacturer": "H2-Pharma, LLC", "application_number": "NDA017533", "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "route": [ "ORAL" ], "effective_time": "20251201", "set_id": "cfa0d79a-843c-4b88-95a1-e9511d649ca1", "has_boxed_warning": true, "controlled": true, "mentions_rems": false }, "faers": { "total": 132688, "serious": 92433, "death": 14549, "hospitalization": 41096, "primary_suspect": 131819, "top_reactions": [ [ "Drug Ineffective", 12456 ], [ "Fatigue", 8849 ], [ "Off Label Use", 8532 ], [ "Nausea", 7536 ], [ "Headache", 7107 ], [ "Anxiety", 6935 ], [ "Pain", 6576 ], [ "Depression", 6094 ], [ "Dyspnoea", 5970 ], [ "Fall", 5896 ], [ "Dizziness", 5818 ], [ "Malaise", 5641 ], [ "Insomnia", 5525 ], [ "Diarrhoea", 5522 ], [ "Vomiting", 5458 ] ], "by_year": { "2019": 13448, "2020": 12376, "2021": 10564, "2022": 9692, "2023": 8472, "2024": 8250, "2025": 8233, "2026": 4177 }, "by_year_primary": { "2019": 13435, "2020": 12344, "2021": 10460, "2022": 9509, "2023": 8292, "2024": 8151, "2025": 8070, "2026": 4103 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class I", "date": "20241118", "reason": "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.", "firm": "Endo USA, Inc.", "status": "Ongoing" }, { "class": "Class I", "date": "20241118", "reason": "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.", "firm": "Endo USA, Inc.", "status": "Ongoing" }, { "class": "Class I", "date": "20241118", "reason": "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.", "firm": "Endo USA, Inc.", "status": "Ongoing" }, { "class": "Class I", "date": "20241118", "reason": "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.", "firm": "Endo USA, Inc.", "status": "Ongoing" }, { "class": "Class I", "date": "20240710", "reason": "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.", "firm": "Endo Pharmaceuticals, Inc.", "status": "Terminated" } ], "recall_total": 5, "drugsfda": { "applications": 19, "nda": 2, "anda": 17, "first_approval": "19750604", "rems": false, "rems_last": "20120719", "labeling_supplements": 22, "labeling_recent": 2, "sponsors": [ "ACCORD HLTHCARE", "ACTAVIS ELIZABETH", "ALEMBIC", "AUROBINDO PHARMA USA", "BARR", "CHARTWELL RX", "CHEPLAPHARM", "PH HEALTH" ], "unapproved": false, "first_approval_fmt": "06/04/1975" }, "trials": { "total": 57, "completed": 30, "terminated": 7, "with_results": 8, "industry": 8, "phase3": 9, "results_share": 0.26666666666666666, "terminated_share": 0.12280701754385964 }, "pubmed": { "rct": 90, "meta": 9, "recent_rct": 10, "cochrane": [ { "pmid": "35187637", "title": "Clonazepam monotherapy for treating people with newly diagnosed epilepsy", "year": "2022" }, { "pmid": "32309880", "title": "Clonazepam add-on therapy for drug-resistant epilepsy", "year": "2020" }, { "pmid": "31742671", "title": "Clonazepam monotherapy for treating people with newly diagnosed epilepsy", "year": "2019" }, { "pmid": "29717488", "title": "Clonazepam add-on therapy for refractory epilepsy in adults and children", "year": "2018" }, { "pmid": "22592742", "title": "Clonazepam for neuropathic pain and fibromyalgia in adults", "year": "2012" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "clonazepam", "Klonopin" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 8859699, "beneficiaries": 1316477, "spend": 74458747.71, "by_brand": [ { "brand": "Clonazepam", "claims": 8844831, "per_claim": 8.0333398829, "is_generic": true }, { "brand": "Klonopin", "claims": 14868, "per_claim": 229.02973366, "is_generic": false } ], "per_claim": 8.404207378828557 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "RemovedFromEml", "name": "clonazepam", "matched": "clonazepam", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 20324, "fills": 8859699, "per_million": 2293.983125160347, "ratio": 0.828466866190003, "median": 2768.949753790441 }, "scores": { "safety": { "score": 35, "letter": "F", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "2,294 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x 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 (1.2x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)", "5 Class I recall(s): reasonable probability of serious harm (-20)" ], "weight": 0.35 }, "evidence": { "score": 39, "letter": "F", "why": [ "90 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed", "5 independent Cochrane review(s) exist", "Only 27% of completed registered trials posted results (-15)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 66, "letter": "C", "why": [ "Recalls since 2016: 5 Class I, 0 Class II, 0 Class III across 17 generic makers (-30)", "2 label changes approved since 2021 (-4)" ], "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": 70, "letter": "C", "why": [ "Generic versions approved (17 applications)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 54, "grade": "D", "questions": [ "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. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "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.)" ] }