Zaleplon: Side Effects, Uses & Monitoring
Sonata is indicated for the short-term treatment of insomnia.
- Data source
- FDA labeling via NIH DailyMed (label 43ac81cb…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Headache | 42% |
| Dizziness | 9% |
| Nausea | 8% |
| Asthenia | 7% |
| Abdominal pain | 6% |
| Somnolence | 6% |
| Amnesia | 4% |
| Eye pain | 4% |
| Dysmenorrhea | 4% |
| Paresthesia | 3% |
| Malaise | 2% |
| Anorexia | 2% |
| Depersonalization | 2% |
| Hypesthesia | 2% |
| Tremor | 2% |
| Abnormal vision | 2% |
| Hyperacusis | 2% |
| Parosmia | 2% |
| Photosensitivity reaction | 1% |
| Colitis | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Sonata is indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
Conditions associated with Zaleplon in labeling
Frequently Asked Questions
What is Zaleplon used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Zaleplon?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Zaleplon. Individual risk varies.
Does Zaleplon require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Zaleplon.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.