What the label lists and what reports show
Zaleplon side effects
Zaleplon's FDA label lists its adverse reactions in its own words. FAERS holds 1,589 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (114 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the zaleplon FDA label on DailyMed (effective May 8, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of zaleplon?Serious side effects of zaleplon include: getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about zaleplon?" ) abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions. memory loss anxiety severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking zaleplon. Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using zaleplon. […]
Source: FDA drug label, Aurobindo Pharma Limited, effective May 8, 2024 (SPL set e092f3ca-bf44-4568-a72c-3fb2cf5b192b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe premarketing development program for zaleplon included zaleplon exposures in patients and/or normal subjects from 2 different groups of studies: approximately 900 normal subjects in clinical pharmacology/pharmacokinetic studies; and approximately 2,900 exposures from patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 450 patient exposure years. The conditions and duration of treatment with zaleplon varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs. …
Table 1 Incidence (%) of Treatment-Emergent Adverse Events in Long-Term (28 and 35 Nights) Placebo-Controlled Clinical Trials of Zaleplon a
| Body System Preferred Term | Placebo (n = 344) | Zaleplon 5 mg or 10 mg (n = 569) | Zaleplon 20 mg (n = 297) |
|---|---|---|---|
| Abdominal pain | 3 | 6 | 6 |
| Asthenia | 5 | 5 | 7 |
| Headache | 35 | 30 | 42 |
| Malaise | <1 | <1 | 2 |
| Photosensitivity reaction | <1 | <1 | 1 |
| Anorexia | <1 | <1 | 2 |
| Colitis | 0 | 0 | 1 |
| Nausea | 7 | 6 | 8 |
| Peripheral edema | <1 | <1 | 1 |
| Amnesia | 1 | 2 | 4 |
| Confusion | <1 | <1 | 1 |
| Depersonalization | <1 | <1 | 2 |
| Dizziness | 7 | 7 | 9 |
| Hallucinations | <1 | <1 | 1 |
| Hypertonia | <1 | 1 | 1 |
| Hypesthesia | <1 | <1 | 2 |
| Paresthesia | 1 | 3 | 3 |
| Somnolence | 4 | 5 | 6 |
| Tremor | 1 | 2 | 2 |
| Vertigo | <1 | <1 | 1 |
| Epistaxis | <1 | <1 | 1 |
| Abnormal vision | <1 | <1 | 2 |
| Ear pain | 0 | <1 | 1 |
| Eye pain | 2 | 4 | 3 |
| Hyperacusis | <1 | 1 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Aurobindo Pharma Limited, effective May 8, 2024 (SPL set e092f3ca-bf44-4568-a72c-3fb2cf5b192b), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,589 reports list zaleplon among the medicines taken, each a report of something that happened, not proof the medicine caused it; 176 are coded as a death and 347 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Zaleplon: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions