Zolpidem side effects: what 134,336 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Zolpidem Tartrate (Zolpidem Tartrate)
Who reports
134,336 reports · 69% serious · 15,992 with death outcome · 64% female
Used for
Zolpidem tartrate extended-release tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed i.
What it is
Zolpidem is an imidazo[1,2-a]pyridine compound having a 4-tolyl group at the 2-position, an N,N-dimethylcarbamoylmethyl group at the 3-position and a methyl substituent at the 6-position.
Boxed 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 zolpidem tartrate extended-release tablets. Some of these events may result in serious injuries, including death.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,121 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sleep walking | 354 | 244.0 206.3–288.5ROR 244.6 · calibrated p 8e-11 ✓ | 94.2 EB05 86.2 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=337 | not reported in cached trials |
| Pharmaceutical nomadism | 218 | 130.3 108.8–156.1ROR 130.5 · calibrated p 2e-8 ✓ | 70.4 EB05 62.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=218 · 100% clinician | not reported in cached trials |
| Neurologic neglect syndrome | 202 | 88.1 74.1–104.7ROR 88.2 · calibrated p 3e-7 ✓ | 56.0 EB05 49.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=202 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Sleep-related eating disorder | 280 | 66.2 57.6–76.2ROR 66.4 · calibrated p 2e-6 ✓ | 46.4 EB05 42.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=197 | not reported in cached trials |
| Abnormal sleep-related event | 391 | 65.2 58.0–73.4ROR 65.4 · calibrated p 3e-6 ✓ | 45.9 EB05 42.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=317 | not reported in cached trials |
| Carotid artery thrombosis | 206 | 49.5 42.3–57.9ROR 49.6 · calibrated p 2e-5 ✓ | 37.5 EB05 33.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=206 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Somnambulism | 1,494 | 45.6 43.1–48.3ROR 46.1 · calibrated p 2e-5 ✓ | 35.4 EB05 33.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=1,132 | not reported in cached trials |
| Prescription form tampering | 142 | 35.2 29.3–42.3ROR 35.3 · calibrated p 1e-4 ✓ | 28.7 EB05 25.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=142 · 100% clinician | not reported in cached trials |
| Adjustment disorder | 227 | 32.7 28.4–37.8ROR 32.8 · calibrated p 2e-4 ✓ | 27.1 EB05 24.3 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=224 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Parasomnia | 119 | 31.8 26.1–38.7ROR 31.8 · calibrated p 2e-4 ✓ | 26.4 EB05 22.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=92 · ♀ 0% (drug 64%) | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 127 | 20.8 17.3–25.0ROR 20.8 · calibrated p 0.002 ✓ | 18.4 EB05 15.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=127 | not reported in cached trials |
| Hyperparathyroidism secondary | 256 | 17.5 15.3–19.9ROR 17.5 · calibrated p 0.004 ✓ | 15.8 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=256 | not reported in cached trials |
| Personality disorder | 260 | 17.0 14.9–19.3ROR 17.0 · calibrated p 0.004 ✓ | 15.4 EB05 13.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=258 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 460 | 16.9 15.4–18.7ROR 17.0 · calibrated p 0.004 ✓ | 15.3 EB05 14.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=460 | not reported in cached trials |
| Sleep talking | 160 | 16.0 13.6–18.9ROR 16.1 · calibrated p 0.006 ✓ | 14.6 EB05 12.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=121 | not reported in cached trials |
| Homicide | 162 | 15.3 13.0–18.0ROR 15.3 · calibrated p 0.007 ✓ | 14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=155 · ♀ 0% (drug 64%) | not reported in cached trials |
| Rebound acid hypersecretion | 217 | 11.8 10.3–13.6ROR 11.8 · calibrated p 0.018 ✓ | 11.0 EB05 9.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=216 | not reported in cached trials |
| Drug use disorder | 555 | 11.2 10.2–12.2ROR 11.2 · calibrated p 0.022 ✓ | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 100% clinician | not reported in cached trials |
| Osteosclerosis | 94 | 9.8 8.0–12.1ROR 9.8 · calibrated p 0.036 ✓ | 9.1 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=94 · ♀ 100% (drug 64%) · 100% consumer | not reported in cached trials |
| Gun shot wound | 106 | 9.2 7.5–11.2ROR 9.2 · calibrated p 0.045 ✓ | 8.5 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=105 · ♀ 0% (drug 64%) · 100% consumer | not reported in cached trials |
| Impaired driving ability | 624 | 9.0 8.3–9.8ROR 9.0 · calibrated p 0.046 ✓ | 8.5 EB05 8.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 | not reported in cached trials |
| Drug withdrawal convulsions | 93 | 8.5 6.9–10.5ROR 8.5 · calibrated p 0.057 | 7.9 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=93 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Completed suicide (death by suicide) | 4,301 | 8.4 8.1–8.6ROR 8.6 · calibrated p 0.053 | 8.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 7.0 · serious PRR 6.6 · 94% clinician | not reported in cached trials |
| Multiple drug overdose intentional | 166 | 8.3 7.1–9.7ROR 8.3 · calibrated p 0.060 | 7.8 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=167 · 100% clinician | not reported in cached trials |
| Sopor | 670 | 8.2 7.6–8.8ROR 8.2 · calibrated p 0.061 | 7.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | age-adj. PRR 6.9 · serious PRR 6.5 · 91% clinician | not reported in cached trials |
| Hangover | 168 | 7.7 6.6–9.0ROR 7.7 · calibrated p 0.075 | 7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Pre-existing condition improved | 299 | 7.7 6.9–8.7ROR 7.7 · calibrated p 0.075 | 7.3 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=144 | not reported in cached trials |
| Psychomotor retardation | 129 | 7.5 6.3–9.0ROR 7.5 · calibrated p 0.082 | 7.1 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=128 · 100% clinician | not reported in cached trials |
| Initial insomnia | 465 | 7.4 6.8–8.1ROR 7.4 · calibrated p 0.083 | 7.1 EB05 6.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | age-adj. PRR 7.3 · serious n=175 | not reported in cached trials |
| Diabetic neuropathy | 225 | 7.3 6.4–8.4ROR 7.4 · calibrated p 0.087 | 7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=222 | not reported in cached trials |
| End stage renal disease | 821 | 7.2 6.7–7.8ROR 7.3 · calibrated p 0.089 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | not reported in cached trials |
| Drug tolerance | 225 | 7.2 6.3–8.2ROR 7.2 · calibrated p 0.092 | 6.8 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=175 | not reported in cached trials |
| Amnesia (memory loss) | 2,881 | 7.2 6.9–7.4ROR 7.3 · calibrated p 0.088 | 6.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.3 · serious PRR 6.4 | not reported in cached trials |
| Poisoning deliberate | 410 | 7.2 6.5–7.9ROR 7.2 · calibrated p 0.093 | 6.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 100% clinician | not reported in cached trials |
| Excoriation | 112 | 7.1 5.8–8.5ROR 7.1 · calibrated p 0.099 | 6.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=99 | not reported in cached trials |
| Spinal osteoarthritis | 377 | 6.9 6.2–7.7ROR 6.9 · calibrated p 0.102 | 6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | not reported in cached trials |
| Bradypnoea | 114 | 6.9 5.7–8.3ROR 6.9 · calibrated p 0.106 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=114 · 100% clinician | not reported in cached trials |
| Exposure via ingestion | 108 | 6.9 5.7–8.3ROR 6.9 · calibrated p 0.108 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=108 · 100% clinician | not reported in cached trials |
| Affect lability | 389 | 6.5 5.9–7.2ROR 6.5 · calibrated p 0.121 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 · ♀ 89% (drug 64%) | not reported in cached trials |
| Sensory loss | 317 | 6.3 5.7–7.1ROR 6.4 · calibrated p 0.130 | 6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 88% (drug 64%) | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Suicidality | 8,681 | 5.75.6–5.8 | signal |
| Depression | 5,317 | 3.02.9–3.1 | signal |
| Hyponatraemia | 1,396 | 2.72.6–2.9 | signal |
| Fall / fracture | 5,947 | 2.52.4–2.5 | signal |
| Extrapyramidal | 1,485 | 2.22.1–2.3 | signal |
| Kidney injury | 6,071 | 2.12.0–2.1 | signal |
| Arrhythmia / qt | 2,475 | 2.01.9–2.1 | raised |
| Dependence / withdrawal | 3,635 | 1.91.9–2.0 | raised |
| Rhabdomyolysis / myopathy | 986 | 1.91.8–2.0 | raised |
| Pancreatitis | 942 | 1.81.7–2.0 | raised |
| Anaemia | 3,494 | 1.81.8–1.9 | raised |
| Venous thromboembolism | 2,417 | 1.81.7–1.8 | raised |
| Gi bleeding | 1,997 | 1.71.6–1.8 | raised |
| Seizure | 2,000 | 1.61.5–1.7 | raised |
| Thrombocytopenia | 2,191 | 1.61.5–1.6 | raised |
| Heart failure | 1,777 | 1.61.5–1.6 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Zolpidem as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT02783729 — Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE (N=1006, PHASE3; 10 AE terms posted; arms: Placebo; Zolpidem Tartrate Extended Release 6.25 ; Lemborexant 5 mg; Lemborexant 10 mg)
- NCT00608985 — Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia (N=709, PHASE3; 35 AE terms posted; arms: Placebo; Almorexant 100mg; Almorexant 200mg; Zolpidem 10mg)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 8,741 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.332 | 1.0 EB05 1.0 · IC025 +0.0 | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.0 | not reported in cached trials |
| Nausea | 8,548 | 1.7 1.7–1.7ROR 1.7 · calibrated p 0.797 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.8 | NCT00608985: 4/168 (2.4%) on Zolpidem; 7/177 (4.0%) control |
| Fatigue (tiredness) | 8,301 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.781 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | NCT00608985: 6/168 (3.6%) on Zolpidem; 2/177 (1.1%) control |
| Pain | 6,489 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.761 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.6 | NCT02783729: 1/263 (0.4%) on Zolpidem (serious AE) |
| Insomnia (trouble sleeping) | 6,339 | 3.8 3.7–3.9ROR 3.9 · calibrated p 0.394 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 3.3 · serious PRR 3.3 | not reported in cached trials |
| Headache | 6,333 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.715 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | NCT02783729: 14/263 (5.3%) on Zolpidem; 13/209 (6.2%) control |
| Diarrhoea (diarrhea) | 5,969 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.624 | 1.4 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.4 | NCT00608985: 2/168 (1.2%) on Zolpidem; 1/177 (0.6%) control |
| Fall | 5,634 | 2.7 2.6–2.7ROR 2.7 · calibrated p 0.714 | 2.6 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 2.3 | not reported in cached trials |
| Anxiety | 5,525 | 3.1 3.0–3.1ROR 3.2 · calibrated p 0.579 | 3.0 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.0 · serious PRR 3.0 | NCT00608985: 2/168 (1.2%) on Zolpidem |
| Dizziness | 5,292 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.765 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.7 | NCT00608985: 3/168 (1.8%) on Zolpidem; 10/177 (5.6%) control |
| Dyspnoea (shortness of breath) | 5,257 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.624 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.3 | not reported in cached trials |
| Vomiting | 4,981 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.763 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | not reported in cached trials |
| Depression | 4,535 | 3.1 3.1–3.2ROR 3.2 · calibrated p 0.560 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 2.8 · serious PRR 2.9 | not reported in cached trials |
| Asthenia (weakness) | 4,529 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.900 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.7 | NCT00608985: 1/168 (0.6%) on Zolpidem; 2/177 (1.1%) control |
| Completed suicide (death by suicide) | 4,301 | 8.4 8.1–8.6ROR 8.6 · calibrated p 0.053 | 8.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 7.0 · serious PRR 6.6 · 94% clinician | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pharmaceutical nomadism — n=218, PRR 130.3
- Neurologic neglect syndrome — n=202, PRR 88.1
- Sleep-related eating disorder — n=280, PRR 66.2
- Abnormal sleep-related event — n=391, PRR 65.2
- Carotid artery thrombosis — n=206, PRR 49.5
- Prescription form tampering — n=142, PRR 35.2
- Parasomnia — n=119, PRR 31.8
- Chronic kidney disease-mineral and bone disorder — n=127, PRR 20.8
- Hyperparathyroidism secondary — n=256, PRR 17.5
- Nephrogenic anaemia — n=460, PRR 16.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Zolpidem ↔ Amnesia.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Zolpidem?
In FDA FAERS, the most frequently co-reported reaction terms for Zolpidem are nausea, fatigue, pain, insomnia, headache, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Zolpidem have an FDA boxed warning?
Yes. The current FDA label carries a boxed 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 zolpidem tartrate extended-release tablets. Some of these events may result in serious injuries, including death.
Do FAERS signals prove that Zolpidem causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0c64bc71-2e7f-4b15-a8e1-acb8de04395f, effective 20231018; matched on
openfda.generic_name.exact:"ZOLPIDEM TARTRATE") - PubChem CID 5732 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,161 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
ZOLPIDEM, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.