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.
How to Take It
Take zaleplon right before you go to bed, or after you are in bed and can't fall asleep. The usual dose for most adults is 10 mg. If you are a low-weight individual, 5 mg may be enough. Do not take more than 20 mg. Avoid taking zaleplon with or right after a heavy, high-fat meal, as this can make it less effective.
This is a plain-language summary of zaleplon's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if zaleplon can harm your unborn baby. Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
This is a plain-language summary of zaleplon's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you forget to take zaleplon, skip the missed dose and take your next dose when you are supposed to. Do not take two doses at the same time.
This is a plain-language summary of zaleplon's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store zaleplon at room temperature (68°F to 77°F) in a light-resistant container.
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
- Feeling sick to your stomach
Feeling sick to your stomach
111 reports
- Killed themselves
Killed themselves
88 reports
- Trouble sleeping
Trouble sleeping
80 reports
- Pain in your head
Pain in your head
79 reports
- Accidentally falling down
Accidentally falling down
77 reports
- Feeling worried or nervous
Feeling worried or nervous
76 reports
- Physical discomfort
Physical discomfort
72 reports
- Feeling tired
Feeling tired
69 reports
- Feeling lightheaded or unsteady
Feeling lightheaded or unsteady
58 reports
- Loose or watery stools
Loose or watery stools
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) 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.
What to do: No special changes are usually needed for this combination. Your doctor may monitor your kidney health if you take these together long-term.
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.
What to do: You can safely take these medicines together as prescribed. No dosage adjustments are typically required.
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.
What to do: No dosage changes are needed when taking these two drugs together. Continue to take them as directed by your healthcare provider.
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.
What to do: No dose adjustments are necessary for either drug. Your doctor will likely continue your routine blood clotting tests as usual.
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.
What to do: Your doctor may need to lower your dose of zaleplon. Watch for increased sleepiness or dizziness while taking both medications.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is zaleplon safe during pregnancy?
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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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: October 16, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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