zaleplon Side Effects
Also known as: Sonata
Analysis of 1,538 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,538
Death-Related
173
11.2% of reports
Hospitalizations
338
22.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 173 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 88 |
| TOXICITY TO VARIOUS AGENTS | 29 |
| DEATH | 27 |
| CARDIAC ARREST | 10 |
| OVERDOSE | 9 |
| INTENTIONAL PRODUCT MISUSE | 8 |
| PNEUMONIA | 8 |
| SUSPECTED SUICIDE | 6 |
| INSOMNIA | 5 |
| RENAL FAILURE | 5 |
| RESPIRATORY FAILURE | 5 |
| CHRONIC KIDNEY DISEASE | 4 |
| ABNORMAL BEHAVIOUR | 3 |
| ACUTE KIDNEY INJURY | 3 |
| ASPIRATION | 3 |
| BRAIN OEDEMA | 3 |
| DEPRESSION | 3 |
| DRUG TOXICITY | 3 |
| FALL | 3 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 3 |
Reactions in Hospitalization Reports
Top reactions in 338 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 33 |
| PNEUMONIA | 22 |
| ACUTE KIDNEY INJURY | 21 |
| NAUSEA | 19 |
| RENAL FAILURE | 19 |
| URINARY TRACT INFECTION | 19 |
| CHRONIC KIDNEY DISEASE | 17 |
| HYPOTENSION | 17 |
| INSOMNIA | 17 |
| SOMNOLENCE | 17 |
| PAIN | 16 |
| TOXICITY TO VARIOUS AGENTS | 16 |
| ANXIETY | 15 |
| COMPLETED SUICIDE | 15 |
| DYSPNOEA | 15 |
| SINUSITIS | 15 |
| VOMITING | 15 |
| DIZZINESS | 14 |
| OVERDOSE | 14 |
| DIARRHOEA | 13 |
Nearby — Related Medications
What the FAERS Data Reveals About zaleplon Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,538 voluntary reports linked to zaleplon and its brand equivalents (Sonata), spanning 2004 through 2025. Of those, 173 (11.2%) listed death as an outcome and 338 (22.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 68% were female and 32% male; age distribution skews toward 45-64, with 406 reports in that bracket. The single most reported reaction is drug ineffective with 140 submissions, followed by nausea and completed suicide.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.