{
 "query": "zolpidem",
 "ingredient": "zolpidem",
 "slug": "zolpidem",
 "rxcui": "39993",
 "brands": [
  "Ambien",
  "Edluar"
 ],
 "names": [
  "zolpidem",
  "zolpidem tartrate"
 ],
 "classes": [
  {
   "id": "N05CF",
   "name": "Benzodiazepine related drugs"
  }
 ],
 "alternatives": [
  "eszopiclone",
  "zaleplon",
  "zopiclone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 110,
   "SUBLINGUAL": 2
  },
  "boxed_warning": "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 AMBIEN. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: COMPLEX SLEEP BEHAVIORS 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 AMBIEN. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )",
  "indications_and_usage": "(zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14) ] . The clinical trials performed in support of efficacy were 4\u20135 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )",
  "contraindications": "is contraindicated in patients who have experienced complex sleep behaviors after taking AMBIEN [see Warnings and Precautions (5.1) ] . with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] . Patients who have experienced complex sleep behaviors after taking AMBIEN ( 4 ) Known hypersensitivity to zolpidem ( 4 )",
  "warnings_and_cautions": "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 against driving and other activities requiring mental alertness the morning after use. Instruct patients on correct use. ( 5.2 ) Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.3 ) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ( 5.4 ) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes. ( 5.5 ) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose. ( 5.6 ) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. ( 5.7 ) Hepatic Impairment: Avoid AMBIEN use in patients with severe hepatic impairment. ( 5.8 ) Withdrawal Effects: Symptoms may occur with r...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions (5.1) ] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2) ] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions (5.4) ] Abnormal Thinking and Behavior Changes [see Warnings and Precautions (5.5) ] Withdrawal Effects [see Warnings and Precautions (5.9) ] Most commonly observed adverse reactions were: Short-term (<10 nights): Drowsiness, dizziness, and diarrhea Long-term (28\u201335 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Associated with Discontinuation of Treatment Approximately 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%),...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation. 9.2 Abuse 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. 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 effects over time. Tolerance may occur to both 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, using a multidisciplinary approach, but relapse is common. Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazep...",
  "controlled_substance": "9.1 Controlled Substance Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.",
  "recent_major_changes": "Dosage and Administration ( 2.1 ) 2/2022 Warnings and Precautions ( 5.5 ) 2/2022 Warnings and Precautions ( 5.7 ) 2/2022",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with AMBIEN. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with AMBIEN and with each prescription refill. Review the AMBIEN Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that AMBIEN should be taken only as prescribed. Complex Sleep Behaviors Instruct patients and their families that AMBIEN 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 AMBIEN 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 AMBIEN has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are n...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2024 8-AMBCP1 MEDICATION GUIDE AMBIEN ( \u0101m'b\u0113-\u0259n) (zolpidem tartrate) tablets, for oral use, C-IV What is the most important information I should know about AMBIEN? AMBIEN may cause serious side effects, including: Complex sleep behaviors. After taking AMBIEN, 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. These activities may happen with AMBIEN whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking AMBIEN have reported: sleep-walking sleep-driving making and eating food talking on the phone having sex Stop taking ABMIEN and tell your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN. What is AMBIEN? AMBIEN is a prescription sleep medicine used for the short-term treatment of adults who have trouble falling asleep (insomnia). It is not known if AMBIEN is safe and effective in ...",
  "clinical_studies": "14.1 Transient Insomnia Normal adults experiencing transient insomnia (n=462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings. Normal elderly adults (mean age 68) experiencing transient insomnia (n=35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality). 14.2 Chronic Insomnia Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV\u2122). Adult outpatients with chronic insomnia (n=75) were evaluated in a doubl...",
  "brand_name": "Ambien",
  "manufacturer": "Cosette Pharmaceuticals, Inc.",
  "application_number": "NDA019908",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250207",
  "set_id": "747949c5-2c91-4909-8a07-71b6826f8e97",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 81800,
  "serious": 55665,
  "death": 8554,
  "hospitalization": 27277,
  "primary_suspect": 81425,
  "top_reactions": [
   [
    "Drug Ineffective",
    5485
   ],
   [
    "Fatigue",
    5147
   ],
   [
    "Nausea",
    4772
   ],
   [
    "Headache",
    3730
   ],
   [
    "Pain",
    3652
   ],
   [
    "Diarrhoea",
    3609
   ],
   [
    "Insomnia",
    3394
   ],
   [
    "Off Label Use",
    3322
   ],
   [
    "Fall",
    3312
   ],
   [
    "Anxiety",
    3102
   ],
   [
    "Dizziness",
    2922
   ],
   [
    "Vomiting",
    2740
   ],
   [
    "Dyspnoea",
    2662
   ],
   [
    "Toxicity To Various Agents",
    2589
   ],
   [
    "Asthenia",
    2519
   ]
  ],
  "by_year": {
   "2019": 8673,
   "2020": 8653,
   "2021": 6448,
   "2022": 5506,
   "2023": 5065,
   "2024": 5054,
   "2025": 5046,
   "2026": 2540
  },
  "by_year_primary": {
   "2019": 8668,
   "2020": 8643,
   "2021": 6420,
   "2022": 5453,
   "2023": 4986,
   "2024": 5002,
   "2025": 4971,
   "2026": 2477
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240118",
   "reason": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20240118",
   "reason": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Completed"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 43,
  "nda": 7,
  "anda": 34,
  "first_approval": "19921216",
  "rems": false,
  "rems_last": "20110928",
  "labeling_supplements": 44,
  "labeling_recent": 6,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "ALMATICA",
   "APOTEX",
   "APOTEX INC",
   "AUROBINDO PHARMA",
   "AYTU",
   "BIOVAIL LABS INTL"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/16/1992"
 },
 "trials": {
  "total": 153,
  "completed": 114,
  "terminated": 11,
  "with_results": 47,
  "industry": 77,
  "phase3": 25,
  "results_share": 0.41228070175438597,
  "terminated_share": 0.0718954248366013
 },
 "pubmed": {
  "rct": 239,
  "meta": 16,
  "recent_rct": 30,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "zolpidem",
   "Ambien",
   "Edluar"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7940675,
  "beneficiaries": 1563487,
  "spend": 77816991.42,
  "by_brand": [
   {
    "brand": "Zolpidem Tartrate",
    "claims": 7548054,
    "per_claim": 6.6392171704,
    "is_generic": true
   },
   {
    "brand": "Zolpidem Tartrate ER",
    "claims": 371133,
    "per_claim": 29.487540235,
    "is_generic": false
   },
   {
    "brand": "Ambien",
    "claims": 13186,
    "per_claim": 786.40446762,
    "is_generic": false
   },
   {
    "brand": "Ambien Cr",
    "claims": 7083,
    "per_claim": 797.86788225,
    "is_generic": false
   },
   {
    "brand": "Edluar",
    "claims": 1219,
    "per_claim": 606.39451189,
    "is_generic": false
   }
  ],
  "per_claim": 9.79979553627368
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20130514",
   "title": "FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm352085.htm",
   "kind": "drug",
   "matched": "zolpidem"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 12450,
  "fills": 7940675,
  "per_million": 1567.8767862933569,
  "ratio": 0.5662351886837512,
  "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 2013 (-8)",
    "1,568 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x 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": 52,
   "letter": "D",
   "why": [
    "239 randomized trials and 16 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 41% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 34 generic makers (-3)",
    "6 label changes approved since 2021: the safety story is still moving (-8)",
    "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 (34 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 69,
 "grade": "C",
 "questions": [
  "In 2013 the FDA issued a safety communication about this drug (FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day ). 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, headache. How would we recognize and handle those?",
  "Why this one over eszopiclone, zaleplon, 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.)"
 ]
}