Prescription medication · Non-Benzodiazepine Hypnotic (Z-Drug)
zolpidem
Also sold as Ambien. Zolpidem is used to treat insomnia when you have trouble falling asleep.
Data updated 2026-05-15
- 131,653
- FDA reportsHeavily reported
- 9
- InteractionsFew interactions
- 77% less
- Generic vs brandBig savings
- $20.57
- Brand price (NADAC)
What the data shows
zolpidem (Ambien) is a prescription Non-Benzodiazepine Hypnotic (Z-Drug), more reported than roughly 9 in 10 tracked drugs (131,653 FDA reports), whose generic runs roughly half the brand price or less (77% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
zolpidem (Ambien) is a prescription Non-Benzodiazepine Hypnotic (Z-Drug). Zolpidem is used to treat insomnia when you have trouble falling asleep.
Zolpidem (Ambien) is a medication that helps you fall asleep faster. It is for short-term use only.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$20.57/unit
Generic Price
$4.69/unit
Generic Savings
77%
Generic Available
Yes (12 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Zolpidem is used to treat insomnia when you have trouble falling asleep.
Common side effects
Drowsiness, Dizziness, Diarrhea
Key warnings
Zolpidem can cause complex sleep behaviors like sleepwalking, sleep driving, and doing other activities while not fully awake.
The sections below are summarized in plain English from zolpidem's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Zolpidem affects a chemical in your brain called gamma-aminobutyric acid (GABA). GABA helps to slow down brain activity. By affecting GABA, zolpidem helps you to feel sleepy.
Side Effects (from patient reports)
Based on 131,653 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for zolpidem, by number of reports
- Nausea
Nausea
8,384 reports
- Fatigue
Fatigue
8,143 reports
- Pain
Pain
6,377 reports
- Insomnia
Insomnia
6,249 reports
- Headache
Headache
6,222 reports
- Diarrhoea
Diarrhoea
5,861 reports
- Fall
Fall
5,524 reports
- Anxiety
Anxiety
5,428 reports
- Dizziness
Dizziness
5,197 reports
- Dyspnoea
Dyspnoea
5,192 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for zolpidem each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where zolpidem sits
zolpidem has more FDA adverse-event reports than 90% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is zolpidem; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 131,653 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
131,653
Reports Mentioning Death
15,695
11.9% of reports — not proof of cause
Hospitalization Reports
45,304
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | NAUSEA | 8,384 |
| 3 | FATIGUE | 8,143 |
| 4 | PAIN | 6,377 |
| 5 | INSOMNIA | 6,249 |
| 6 | HEADACHE | 6,222 |
| 7 | DIARRHOEA | 5,861 |
| 8 | FALL | 5,524 |
| 9 | ANXIETY | 5,428 |
| 10 | DIZZINESS | 5,197 |
| 11 | DYSPNOEA | 5,192 |
| 12 | VOMITING | 4,863 |
| 13 | DEPRESSION | 4,473 |
| 14 | ASTHENIA | 4,434 |
| 15 | COMPLETED SUICIDE | 4,172 |
| 16 | TOXICITY TO VARIOUS AGENTS | 3,922 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Zolpidem can cause complex sleep behaviors like sleepwalking, sleep driving, and doing other activities while not fully awake. Some of these events can cause serious injuries or even death. Stop taking zolpidem right away if you experience any of these behaviors.
Known Drug Interactions
John's wort): Combination use may decrease effect ( 7.2 ) Ketoconazole: Combination use may increase effect ( 7.2 ) 7.1 CNS-Active Drugs CNS Depressants Coadministration of Zolpidem with other CNS depressants increases the risk of CNS depression. CYP3A4 Inhibitors Ketoconazole Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of Zolpidem.
Mechanism: Ketoconazole blocks the liver enzyme that breaks down zolpidem, which causes the sleep medicine to stay in your body longer.
7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. CYP3A4 Inducers Rifampin Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of Zolpidem. Use of Rifampin in combination with Zolpidem may decrease the efficacy of Zolpidem and is not...
Mechanism: Rifampin speeds up how fast your body gets rid of zolpidem, which makes the sleep medicine much less effective.
7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. Limit dosage and duration of concomitant use of Zolpidem Tartrate Tablets and opioids [ see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.7 )] Imipramine, Chlorpromazine Imipramine in combination with Zolpidem...
Mechanism: Both drugs slow down the central nervous system, which can lead to a combined effect that makes you feel much less alert.
7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. Limit dosage and duration of concomitant use of Zolpidem Tartrate Tablets and opioids [ see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.7 )] Imipramine, Chlorpromazine Imipramine in combination with Zolpidem...
Mechanism: These medicines both cause drowsiness and slow down your physical reactions, which can impair your coordination and alertness.
Sertraline Concomitant administration of Zolpidem and sertraline increases exposure to Zolpidem [see Clinical Pharmacology ( 12.3 )].
Mechanism: Sertraline increases the amount of zolpidem that stays in your bloodstream.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take zolpidem every night?
Can I drink alcohol while taking zolpidem?
What should I do if I feel sleepy the next day?
Can I drive after taking zolpidem?
Is zolpidem addictive?
Can I take more than 10 mg of zolpidem?
What if zolpidem doesn't help me sleep?
Can I stop taking zolpidem suddenly?
Does zolpidem interact with other medications?
Can children take zolpidem?
What are the common side effects of zolpidem?
Does zolpidem interact with other medications?
What drug class is zolpidem?
Is there a generic version of zolpidem?
What pregnancy or breastfeeding source fields are listed for zolpidem?
Related Medications in Non-Benzodiazepine Hypnotic (Z-Drug)
Other drugs grouped near zolpidem - same-class peers and common alternatives.
eszopiclone
Lunesta
Eszopiclone (Lunesta) is a medicine that helps you fall asleep and stay asleep.
Compare with zolpidem →
lemborexant
Dayvigo
Dayvigo is a medicine that can help you fall asleep and stay asleep.
Compare with zolpidem →
melatonin
Melatonin
Melatonin is a hormone supplement that can help with sleep.
Compare with zolpidem →
ramelteon
Rozerem
Ramelteon (Rozerem) is a prescription medicine that can help you fall asleep faster.
Compare with zolpidem →
suvorexant
Belsomra
Belsomra is a prescription medicine used to treat insomnia.
Compare with zolpidem →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for zolpidem: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 131,653.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.92%.
- cefuroxime Δ 0.02 pts · 11,087 reports · Second-Generation Cephalosporin 11.94%death share
- exemestane Δ 0.04 pts · 20,856 reports · Aromatase Inhibitor (Steroidal) 11.88%death share
- tobramycin Δ 0.05 pts · 23,287 reports · Aminoglycoside Antibiotic 11.87%death share
- colchicine Δ 0.06 pts · 28,502 reports · Anti-Gout Agent 11.99%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on zolpidem
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What the FDA Data Shows for zolpidem
The FDA label for zolpidem (sold under brand names such as Ambien) classifies it as a prescription-only medication in the Non-Benzodiazepine Hypnotic (Z-Drug) class. Zolpidem is used to treat insomnia when you have trouble falling asleep. Official labeling lists 4 commonly reported side effects, including Drowsiness, Dizziness, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 131,653 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $4.69 versus $20.57 for the brand - a 77% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: November 16, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages