Prescription medication · Non-Benzodiazepine Hypnotic (Z-Drug)
zaleplon
Also sold as Sonata. Zaleplon is used to treat insomnia, which means you have trouble falling asleep.
Data updated 2026-05-15
- 1,538
- FDA reportsRarely reported
- 16
- InteractionsSeveral interactions
- $0.13
- Generic price (NADAC)
What the data shows
zaleplon (Sonata) is a prescription Non-Benzodiazepine Hypnotic (Z-Drug), among the least-reported drugs the FDA tracks (1,538 FDA reports), with 16 documented drug interactions.
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.
zaleplon (Sonata) is a prescription Non-Benzodiazepine Hypnotic (Z-Drug). Zaleplon is used to treat insomnia, which means you have trouble falling asleep.
Zaleplon (Sonata) is a medicine that helps you fall asleep faster. It is used for short-term treatment of insomnia.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.13/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Zaleplon is used to treat insomnia, which means you have trouble falling asleep.
Common side effects
Headache, Dizziness, Somnolence (sleepiness)
Key warnings
Zaleplon 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 zaleplon's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Zaleplon is a non-benzodiazepine hypnotic. It works by slowing activity in the brain to allow sleep. It affects certain brain chemicals to help you fall asleep.
Side Effects (from patient reports)
Based on 1,538 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for zaleplon, by number of reports
- Nausea
Nausea
111 reports
- Completed Suicide
Completed Suicide
88 reports
- Insomnia
Insomnia
80 reports
- Headache
Headache
79 reports
- Fall
Fall
77 reports
- Anxiety
Anxiety
76 reports
- Pain
Pain
72 reports
- Fatigue
Fatigue
69 reports
- Dizziness
Dizziness
58 reports
- Diarrhoea
Diarrhoea
57 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 zaleplon 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 zaleplon sits
zaleplon has more FDA adverse-event reports than 10% 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 zaleplon; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 1,538 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
1,538
Reports Mentioning Death
173
11.2% of reports — not proof of cause
Hospitalization Reports
338
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | NAUSEA | 111 |
| 3 | COMPLETED SUICIDE | 88 |
| 4 | INSOMNIA | 80 |
| 5 | HEADACHE | 79 |
| 6 | FALL | 77 |
| 7 | ANXIETY | 76 |
| 8 | PAIN | 72 |
| 9 | FATIGUE | 69 |
| 10 | DIZZINESS | 58 |
| 11 | DIARRHOEA | 57 |
| 12 | DEPRESSION | 50 |
| 13 | MALAISE | 49 |
| 15 | VOMITING | 49 |
| 16 | CHRONIC KIDNEY DISEASE | 46 |
| 17 | SOMNOLENCE | 46 |
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
Zaleplon can cause complex sleep behaviors like sleepwalking, sleep-driving, and doing other activities while not fully awake. Some of these activities can result in serious injuries or even death. Stop taking zaleplon immediately and call your doctor if you experience any of these behaviors. Zaleplon can be habit-forming. Keep it in a safe place to prevent misuse.
Known Drug Interactions
Drugs That Alter Renal Excretion Ibuprofen: Ibuprofen is known to affect renal function and, consequently, alter the renal excretion of other drugs. There was no apparent pharmacokinetic interaction between zaleplon and ibuprofen following single dose administration (10 mg and 600 mg, respectively) of each drug.
Mechanism: Ibuprofen can change how the kidneys filter medicine, but it does not appear to change the levels of zaleplon in the body.
Venlafaxine: Coadministration of a single dose of zaleplon 10 mg and multiple doses of venlafaxine ER (extended release) 150 mg did not result in any significant changes in the pharmacokinetics of either zaleplon or venlafaxine. In addition, there was no pharmacodynamic interaction as a result of coadministration of zaleplon and venlafaxine ER.
Mechanism: These two drugs do not interfere with how the body processes each other and do not change each other's effects.
Paroxetine: Coadministration of a single dose of zaleplon 20 mg and paroxetine 20 mg daily for 7 days did not produce any interaction on psychomotor performance. Additionally, paroxetine did not alter the pharmacokinetics of zaleplon, reflecting the absence of a role of CYP2D6 in zaleplon 's metabolism.
Mechanism: Paroxetine does not change how zaleplon is broken down by the body and does not increase its side effects on movement or thinking.
Warfarin: Multiple oral doses of zaleplon (20 mg q24h for 13 days) did not affect the pharmacokinetics of warfarin (R+)- or (S-)-enantiomers or the pharmacodynamics (prothrombin time) following a single 25-mg oral dose of warfarin.
Mechanism: Zaleplon does not change the levels of warfarin in your blood or how well warfarin works to thin the blood.
Other strong selective CYP3A4 inhibitors such as ketoconazole can also be expected to increase the exposure of zaleplon.
Mechanism: Ketoconazole slows down the liver's ability to process zaleplon, which can lead to higher levels of the sleep medicine in your blood.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take zaleplon every night?
What should I do if zaleplon doesn't help me sleep?
Can I drink alcohol while taking zaleplon?
Can I drive after taking zaleplon?
What happens if I take too much zaleplon?
Can I take zaleplon with other medications?
Is zaleplon addictive?
What if I wake up in the middle of the night after taking zaleplon?
Can older adults take zaleplon?
What should I do if I have side effects from zaleplon?
What are the common side effects of zaleplon?
Does zaleplon interact with other medications?
What drug class is zaleplon?
What pregnancy or breastfeeding source fields are listed for zaleplon?
Related Medications in Non-Benzodiazepine Hypnotic (Z-Drug)
Other drugs grouped near zaleplon - same-class peers and common alternatives.
eszopiclone
Lunesta
Eszopiclone (Lunesta) is a medicine that helps you fall asleep and stay asleep.
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lemborexant
Dayvigo
Dayvigo is a medicine that can help you fall asleep and stay asleep.
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melatonin
Melatonin
Melatonin is a hormone supplement that can help with sleep.
Compare with zaleplon →
ramelteon
Rozerem
Ramelteon (Rozerem) is a prescription medicine that can help you fall asleep faster.
Compare with zaleplon →
suvorexant
Belsomra
Belsomra is a prescription medicine used to treat insomnia.
Compare with zaleplon →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for zaleplon: 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: 1,538.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.25%.
- pantoprazole Δ 0.01 pts · 240,800 reports · Proton Pump Inhibitor (PPI) 11.25%death share
- terazosin Δ 0.01 pts · 7,436 reports · Alpha-1 Blocker 11.24%death share
- metronidazole topical Δ 0.03 pts · 45,816 reports · Topical Antibiotic (Rosacea) 11.28%death share
- nifedipine Δ 0.04 pts · 45,410 reports · Calcium Channel Blocker 11.28%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
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What the FDA Data Shows for zaleplon
The FDA label for zaleplon (sold under brand names such as Sonata) classifies it as a prescription-only medication in the Non-Benzodiazepine Hypnotic (Z-Drug) class. Zaleplon is used to treat insomnia, which means you have trouble falling asleep. Official labeling lists 3 commonly reported side effects, including Headache, Dizziness, Somnolence (sleepiness).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,538 voluntary reports. The database also lists 16 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.13.
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: October 16, 2025
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