{
 "query": "suvorexant",
 "ingredient": "suvorexant",
 "slug": "suvorexant",
 "rxcui": "1547099",
 "brands": [
  "Belsomra"
 ],
 "names": [
  "suvorexant"
 ],
 "classes": [
  {
   "id": "N05CJ",
   "name": "Orexin receptor antagonists"
  }
 ],
 "alternatives": [
  "daridorexant",
  "lemborexant"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance ( 1 ).",
  "contraindications": "is contraindicated in patients with narcolepsy. BELSOMRA is contraindicated in patients with narcolepsy ( 4 ).",
  "warnings_and_cautions": "Depressant Effects and Daytime Impairment: Risk of impaired alertness and motor coordination, including impaired driving; risk increases with dose; caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness ( 5.1 ). Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Risk increases with dose. Immediately evaluate any new behavioral changes ( 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 ). Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with the use of BELSOMRA. Risk increases with dose ( 5.4 ). Compromised Respiratory Function: Effect on respiratory function should be considered ( 5.5 , 8.6 ). 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 BELSOMRA is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed....",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections: CNS Depressant Effects and Daytime Impairment [see Warnings and Precautions (5.1) ] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions (5.2) ] Complex Sleep Behaviors [see Warnings and Precautions (5.3) ] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms [see Warnings and Precautions (5.4) ] Patients with Compromised Respiratory Function [see Warnings and Precautions (5.5) ] The most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) with BELSOMRA was somnolence ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 clinical practice. In 3-month controlled efficacy trials (Study 1 and Study 2), 1263 patie...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance BELSOMRA contains suvorexant, a Schedule IV controlled substance. 9.2 Abuse Abuse of BELSOMRA poses an increased risk of somnolence, daytime sleepiness, impaired reaction time and impaired driving skills [see Warnings and Precautions (5.1) ] . Patients at risk for abuse may include those with prolonged use of BELSOMRA, those with a history of drug abuse, and those who use BELSOMRA in combination with alcohol or other abused drugs. Drug abuse is the intentional non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. 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 to other activities and obligations), and possible tolerance or physical dependence. In an abuse liability study conducted in recreational polydrug users (n=36), suvorexant (40, 80 and 150 mg) produced similar effects as zolpidem (15, 30 mg) on subjective ratings of \"drug liking\" and other measures of subjective drug effects. Because indiv...",
  "controlled_substance": "9.1 Controlled Substance BELSOMRA contains suvorexant, a Schedule IV controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). CNS Depressant Effects and Next-Day Impairment Tell patients that BELSOMRA has the potential to cause next-day impairment, and that this risk is increased with higher doses or if dosing instructions are not carefully followed. Patients using the 20 mg dose should be cautioned against next-day driving and other activities requiring full mental alertness as this dose is associated with a higher risk of impaired driving. Patients taking lower doses should also be cautioned about the potential for driving impairment because there is individual variation in sensitivity to BELSOMRA. Patients should not drive or engage in other activities requiring full alertness within 8 hours of dosing of BELSOMRA. Advise patients that increased drowsiness may increase the risk of falls in some patients [see Warnings and Precautions (5.1) ] . Sleep-Driving and Other Complex Behaviors Instruct patients to inform their families that BELSOMRA has been associated with getting out of bed while not being fully awake, and tell patients and their families to call their healthcare providers if this occurs. Hypnotics, like BELSOMRA, ...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 3/2025 MEDICATION GUIDE BELSOMRA \u00ae (bell-SOM-rah) suvorexant Tablets C-IV What is the most important information I should know about BELSOMRA? BELSOMRA may cause serious side effects including: Decreased awareness and alertness. The morning after you take BELSOMRA, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Do not take more BELSOMRA than prescribed. Do not take BELSOMRA unless you are able to stay in bed a full night (at least 7 hours) before you must be active again. Take BELSOMRA within 30 minutes of going to bed. See \" What are the possible side effects of BELSOMRA? \" for more information about side effects. What is BELSOMRA? BELSOMRA is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). It is not known if BELSOMRA is safe and effective in children under the age of 18. BELSOMRA is a federally controlled substance (C-IV) because it can be abused or cause dependence. Keep BELSOMRA in a safe place to prevent misuse and abuse. Selling or giving away BELSOMRA may harm others and is against ...",
  "clinical_studies": "14.1 Controlled Clinical Studies BELSOMRA was evaluated in three clinical trials in patients with insomnia characterized by difficulties with sleep onset and sleep maintenance. Two similarly designed, 3-month, randomized, double-blind, placebo-controlled, parallel-group studies were conducted (Study 1 and Study 2). In both studies, non-elderly (age 18-64) and elderly (age \u2265 65) patients were randomized separately. For the studies together, non-elderly adults (mean age 46 years; 465 females, 275 males) were treated with BELSOMRA 20 mg (n=291) or placebo (n=449). Elderly patients (mean age 71 years, 346 females, 174 males) were treated with BELSOMRA 15 mg (n=202) or placebo (n=318). In Study 1 and Study 2, BELSOMRA 15 mg or 20 mg was superior to placebo for sleep latency as assessed both objectively by polysomnography (Table 3) and subjectively by patient-estimated sleep latency (Table 4). BELSOMRA 15 mg or 20 mg was also superior to placebo for sleep maintenance, as assessed both objectively by polysomnography (Table 5) and subjectively by patient-estimated total sleep time (Table 6). The effects of BELSOMRA at night 1 (objective) and week 1 (subjective) were generally consistent wi...",
  "brand_name": "BELSOMRA",
  "manufacturer": "Merck Sharp & Dohme LLC",
  "application_number": "NDA204569",
  "pharm_class_epc": [
   "Orexin Receptor Antagonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250310",
  "set_id": "e5b72731-1acb-45b7-9c13-290ad12d3951",
  "has_boxed_warning": false,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 12888,
  "serious": 4437,
  "death": 696,
  "hospitalization": 2027,
  "primary_suspect": 12867,
  "top_reactions": [
   [
    "Drug Ineffective",
    3030
   ],
   [
    "Nightmare",
    740
   ],
   [
    "Somnolence",
    731
   ],
   [
    "Insomnia",
    680
   ],
   [
    "Abnormal Dreams",
    602
   ],
   [
    "Headache",
    545
   ],
   [
    "Feeling Abnormal",
    489
   ],
   [
    "Nausea",
    388
   ],
   [
    "Hallucination",
    374
   ],
   [
    "No Adverse Event",
    372
   ],
   [
    "Fatigue",
    360
   ],
   [
    "Dizziness",
    334
   ],
   [
    "Anxiety",
    312
   ],
   [
    "Fall",
    269
   ],
   [
    "Off Label Use",
    266
   ]
  ],
  "by_year": {
   "2019": 926,
   "2020": 783,
   "2021": 714,
   "2022": 600,
   "2023": 602,
   "2024": 491,
   "2025": 416,
   "2026": 187
  },
  "by_year_primary": {
   "2019": 926,
   "2020": 783,
   "2021": 712,
   "2022": 595,
   "2023": 598,
   "2024": 484,
   "2025": 415,
   "2026": 187
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250721",
   "reason": "Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.",
   "firm": "Merck & Co. Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 2,
  "nda": 1,
  "anda": 0,
  "first_approval": "20140813",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 6,
  "labeling_recent": 2,
  "sponsors": [
   "HETERO LABS LTD UNIT III",
   "MERCK SHARP DOHME"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/13/2014"
 },
 "trials": {
  "total": 69,
  "completed": 45,
  "terminated": 7,
  "with_results": 40,
  "industry": 28,
  "phase3": 7,
  "results_share": 0.8888888888888888,
  "terminated_share": 0.10144927536231885
 },
 "pubmed": {
  "rct": 47,
  "meta": 10,
  "recent_rct": 21,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 10.87,
  "records": 1,
  "by_name": [
   [
    "Belsomra",
    10.87
   ]
  ],
  "names_checked": [
   "suvorexant",
   "Belsomra"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 315401,
  "beneficiaries": 77098,
  "spend": 150180014.54,
  "by_brand": [
   {
    "brand": "Belsomra",
    "claims": 315401,
    "per_claim": 476.15579703,
    "is_generic": false
   }
  ],
  "per_claim": 476.1557970329834
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1086,
  "fills": 315401,
  "per_million": 3443.235753849861,
  "ratio": 1.2435168782446788,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 88,
   "letter": "A",
   "why": [
    "3,443 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site (-2)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "47 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": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III (-6)",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $11 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": 77,
 "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 nightmare, somnolence, insomnia. How would we recognize and handle those?",
  "Why this one over daridorexant, lemborexant? 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.)"
 ]
}