{
 "query": "lemborexant",
 "ingredient": "lemborexant",
 "slug": "lemborexant",
 "rxcui": "2272403",
 "brands": [
  "Dayvigo"
 ],
 "names": [
  "lemborexant"
 ],
 "classes": [
  {
   "id": "N05CJ",
   "name": "Orexin receptor antagonists"
  }
 ],
 "alternatives": [
  "daridorexant",
  "suvorexant"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies ( 14.1 )] . DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )",
  "contraindications": "DAYVIGO is contraindicated in patients with narcolepsy. DAYVIGO is contraindicated in patients with narcolepsy. ( 4 )",
  "warnings_and_cautions": "CNS Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases with dose and use with other central nervous system (CNS) depressants. For patients taking DAYVIGO 10 mg, caution against next-day driving and other activities requiring complete mental alertness. ( 5.1 ) Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with use of DAYVIGO. ( 5.2 ) Complex Sleep Behaviors: Behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if a complex sleep behavior occurs. ( 5.3 ) Compromised Respiratory Function: Effect on respiratory function should be considered. ( 5.4 , 8.8 ) Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Prescribe the lowest number of tablets feasible to avoid intentional overdosage. ( 5.5 ) Need to Evaluate for Co-morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment. ( 5.6 ) 5.1 CNS Depressant Effects and Daytime Impairment DAYVIGO is a central nervous system (CNS) depressant that can impair daytim...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: CNS Depressant Effects and Daytime Impairment [see Warnings and Precautions ( 5.1 )] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms [see Warnings and Precautions ( 5.2 )] Complex Sleep Behaviors [see Warnings and Precautions ( 5.3 )] Patients with Compromised Respiratory Function [see Warnings and Precautions ( 5.4 )] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions ( 5.5 )] The most common adverse reaction (reported in \u22655% of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 practice. The safety of DAYVIGO was evaluated in 1418 adult patients with insomnia disorde...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance DAYVIGO contains lemborexant, a Schedule IV controlled substance. 9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential study conducted in recreational sedative abusers (n=29), lemborexant 10 mg, 20 mg (two times the maximum recommended dose), and 30 mg (three times the maximum recommended dose) produced responses on positive subjective measures such as \u201cDrug Liking,\u201d \u201cOverall Drug Liking,\u201d \u201cTake Drug Again,\u201d and \u201cGood Drug Effects\u201d that were statistically similar to those produced by the sedatives zolpidem (30 mg) and suvorexant (40 mg), and statistically greater than the responses on these measures that were produced by placebo. Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to DAYVIGO, follow such patients carefully. 9.3 Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. I...",
  "controlled_substance": "9.1 Controlled Substance DAYVIGO contains lemborexant, a Schedule IV controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Administration Instructions Advise patients to take DAYVIGO only when preparing for or getting into bed and only if they can stay in bed for a full night (at least 7 hours) before being active again [see Dosage and Administration ( 2.1 ) ] . Advise patients that the effect of DAYVIGO may be delayed if taken with or soon after a meal [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 )] . CNS Depressant Effects and Daytime Impairment Advise patients that DAYVIGO can impair daytime wakefulness even when used as prescribed. The risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken. If DAYVIGO is taken in these circumstances, caution patients against driving and other activities requiring complete mental alertness. Advise patients that increased drowsiness may increase the risk of falls in some patients [see Warnings and Precautions ( 5.1 )]. Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms Advise patients and their families that DAYVIGO may cause sleep p...",
  "spl_medguide": "MEDICATION GUIDE DAYVIGO \u00ae (daye-vi'-goe) (lemborexant) tablets, for oral use , CIV What is the most important information I should know about DAYVIGO? DAYVIGO may cause serious side effects including: Decreased awareness and alertness. The morning after you take DAYVIGO, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. \u25cb Do not take more DAYVIGO than prescribed. \u25cb Do not take DAYVIGO unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again. \u25cb Take DAYVIGO right before going to bed. See \u201cWhat are the possible side effects of DAYVIGO?\u201d for more information about side effects. What is DAYVIGO? DAYVIGO is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). It is not known if DAYVIGO is safe and effective in children under the age of 18 years. DAYVIGO is a federally controlled substance (CIV) because it can be abused or cause dependence. Keep DAYVIGO in a safe place to prevent misuse and abuse. Selling or giving away DAYVIGO may harm others and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, pres...",
  "clinical_studies": "14.1 Controlled Clinical Studies DAYVIGO was evaluated in two clinical trials in patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance (Study 1, NCT02952820 and Study 2, NCT02783729). Study 1 was a 6-month, randomized, double-blind, placebo-controlled, multi-center trial in adult patients age 18 or older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly. The primary efficacy endpoint was the mean change from baseline to end of treatment at 6 months for log-transformed patient-reported (subjective) sleep onset latency (sSOL), defined as the estimated minutes from the time that the patient attempted to sleep until sleep onset. Pre-specified secondary efficacy endpoints for sleep maintenance were change from baseline to end of treatment at 6 months for patient-reported sleep efficiency (sSEF) and wake after sleep onset (sWASO). sSEF is defined as the proportion of time spent asleep per time in bed. sWASO is defined as the minutes of wake from the onset of sleep until wake time. The primary and pre-specified secondary efficacy endpoints were meas...",
  "brand_name": "DAYVIGO",
  "manufacturer": "Eisai Inc.",
  "application_number": "NDA212028",
  "pharm_class_epc": [
   "Orexin Receptor Antagonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250224",
  "set_id": "7074cb65-77b3-45d2-8e8d-da8dc0f70bfd",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 1",
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 2744,
  "serious": 2108,
  "death": 326,
  "hospitalization": 1206,
  "primary_suspect": 2726,
  "top_reactions": [
   [
    "Drug Ineffective",
    309
   ],
   [
    "Off Label Use",
    191
   ],
   [
    "Suicide Attempt",
    148
   ],
   [
    "Somnolence",
    140
   ],
   [
    "Condition Aggravated",
    131
   ],
   [
    "Suicidal Ideation",
    130
   ],
   [
    "Fall",
    105
   ],
   [
    "Nausea",
    95
   ],
   [
    "Headache",
    93
   ],
   [
    "Dizziness",
    90
   ],
   [
    "Insomnia",
    87
   ],
   [
    "Sleep Paralysis",
    87
   ],
   [
    "Malaise",
    79
   ],
   [
    "Nightmare",
    77
   ],
   [
    "Pyrexia",
    77
   ]
  ],
  "by_year": {
   "2019": 2,
   "2020": 199,
   "2021": 320,
   "2022": 376,
   "2023": 418,
   "2024": 554,
   "2025": 598,
   "2026": 275
  },
  "by_year_primary": {
   "2019": 2,
   "2020": 199,
   "2021": 319,
   "2022": 371,
   "2023": 414,
   "2024": 551,
   "2025": 593,
   "2026": 275
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20191220",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 4,
  "labeling_recent": 3,
  "sponsors": [
   "EISAI INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/20/2019"
 },
 "trials": {
  "total": 51,
  "completed": 26,
  "terminated": 3,
  "with_results": 15,
  "industry": 29,
  "phase3": 7,
  "results_share": 0.5769230769230769,
  "terminated_share": 0.058823529411764705
 },
 "pubmed": {
  "rct": 35,
  "meta": 10,
  "recent_rct": 27,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 29045.86,
  "records": 9,
  "by_name": [
   [
    "Dayvigo",
    29045.86
   ]
  ],
  "names_checked": [
   "lemborexant",
   "Dayvigo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 57890,
  "beneficiaries": 14593,
  "spend": 20975238.22,
  "by_brand": [
   {
    "brand": "Dayvigo",
    "claims": 57890,
    "per_claim": 362.32921437,
    "is_generic": false
   }
  ],
  "per_claim": 362.32921437208495
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "35 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $29,046 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 60,
   "letter": "D",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "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 suicide attempt, somnolence. 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?",
  "Why this one over daridorexant, suvorexant? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}