{
 "query": "temazepam",
 "ingredient": "temazepam",
 "slug": "temazepam",
 "rxcui": "10355",
 "brands": [
  "Restoril"
 ],
 "names": [
  "temazepam"
 ],
 "classes": [
  {
   "id": "N05CD",
   "name": "Benzodiazepine derivatives"
  }
 ],
 "alternatives": [
  "brotizolam",
  "estazolam",
  "flunitrazepam",
  "flurazepam",
  "lormetazepam",
  "midazolam",
  "nitrazepam",
  "quazepam",
  "remimazolam",
  "triazolam",
  "triazulenone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 47
  },
  "boxed_warning": "WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and Drug Interactions ). \u2022 Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. \u2022 Limit dosages and durations to the minimum required. \u2022 Follow patients for signs and symptoms of respiratory depression and sedation.",
  "indications_and_usage": "INDICATIONS AND USAGE Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
  "contraindications": "CONTRAINDICATIONS Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, t...",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Concomitant use of benzodiazepines, including temazepam capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in 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 temazepam capsules 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. In patients already receiving an opioid analgesic, prescribe a lower initial dose of temazepam capsules than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking temazepam capsules, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when temazepam caps...",
  "adverse_reactions": "ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam capsules at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam Capsules % Incidence (n=1076) Placebo % Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2.0 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System \u2013 anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular \u2013 dyspnea, palpitations Gastrointestinal \u2013 vomiting Musculoskeletal \u2013 backache Special Senses \u2013 hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical 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's 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, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. Controlled Su...",
  "controlled_substance": "Controlled Substance Temazepam capsules are a controlled substance in Schedule IV.",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients The text of a patient Medication Guide is printed at the end of this insert. To assure safe and effective use of temazepam capsules, the information and instructions provided in this patient Medication Guide should be discussed with patients.",
  "spl_medguide": "MEDICATION GUIDE Temazepam (te-maz'\u0115-pam) Capsules, C-IV What is the most important information I should know about temazepam capsules? Temazepam capsules are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. After taking temazepam capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with temazepam capsules. Reported activities include: o driving a car (\u201csleep-driving\u201d) o making and eating food o talking on the phone o having sex o sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking temazepam capsules. Do not take temazepam capsules unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. Do not take more temazepam capsu...",
  "clinical_studies": "",
  "brand_name": "TEMAZEPAM",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "NDA018163",
  "pharm_class_epc": [
   "Benzodiazepine [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20190326",
  "set_id": "405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1",
  "has_boxed_warning": true,
  "boxed_labels": "42 of 47",
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 25240,
  "serious": 18241,
  "death": 4760,
  "hospitalization": 7800,
  "primary_suspect": 25125,
  "top_reactions": [
   [
    "Fatigue",
    2130
   ],
   [
    "Toxicity To Various Agents",
    1908
   ],
   [
    "Drug Ineffective",
    1885
   ],
   [
    "Headache",
    1693
   ],
   [
    "Pain",
    1612
   ],
   [
    "Nausea",
    1543
   ],
   [
    "Off Label Use",
    1543
   ],
   [
    "Diarrhoea",
    1235
   ],
   [
    "Death",
    1132
   ],
   [
    "Fall",
    1114
   ],
   [
    "Overdose",
    1054
   ],
   [
    "Insomnia",
    1036
   ],
   [
    "Back Pain",
    1021
   ],
   [
    "Dyspnoea",
    1011
   ],
   [
    "Dizziness",
    1005
   ]
  ],
  "by_year": {
   "2019": 2660,
   "2020": 2451,
   "2021": 1882,
   "2022": 1345,
   "2023": 1421,
   "2024": 1525,
   "2025": 1171,
   "2026": 520
  },
  "by_year_primary": {
   "2019": 2657,
   "2020": 2445,
   "2021": 1861,
   "2022": 1314,
   "2023": 1402,
   "2024": 1505,
   "2025": 1164,
   "2026": 517
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 24,
  "nda": 1,
  "anda": 17,
  "first_approval": "19810227",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "AUROBINDO PHARMA USA",
   "CHARTWELL RX",
   "DURAMED PHARMS BARR",
   "NOVEL LABS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/27/1981"
 },
 "trials": {
  "total": 13,
  "completed": 12,
  "terminated": 1,
  "with_results": 2,
  "industry": 3,
  "phase3": 3,
  "results_share": 0.16666666666666666,
  "terminated_share": 0.07692307692307693
 },
 "pubmed": {
  "rct": 122,
  "meta": 1,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "temazepam",
   "Restoril"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2218789,
  "beneficiaries": 373754,
  "spend": 27419314.560000002,
  "by_brand": [
   {
    "brand": "Temazepam",
    "claims": 2218319,
    "per_claim": 12.039021403,
    "is_generic": true
   },
   {
    "brand": "Restoril",
    "claims": 470,
    "per_claim": 1516.8609362,
    "is_generic": false
   }
  ],
  "per_claim": 12.357783709942677
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3186,
  "fills": 2218789,
  "per_million": 1435.9184221663259,
  "ratio": 0.5185787211200507,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 53,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "1,436 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death appears in 2.1x the share of reports seen across all of FAERS (-7)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 32,
   "letter": "F",
   "why": [
    "122 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 17% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (17 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "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, toxicity to various agents, headache. How would we recognize and handle those?",
  "Why this one over brotizolam, estazolam, flunitrazepam? 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.)"
 ]
}