OpenClaim

Zaleplon Side Effects

The most commonly reported side effects of zaleplon include nausea, fatigue, and insomnia, based on 3,426 FDA adverse event reports from 2004 to 2025. 6.5% of reports found the drug to be ineffective.

Zaleplon side effects

Percentages show how often each reaction appears relative to total reports for zaleplon.

1
Drug Ineffective6.5%222
2
Drug Ineffective5.9%201
3
Nausea5.0%173
4
Fatigue4.1%139
5
Insomnia4.0%138
6
Headache3.6%125
7
Anxiety3.6%123
8
Pain3.6%122
9
Fall3.5%119
10
Insomnia3.2%108
11
Dizziness2.9%100
12
Diarrhoea2.7%93
13
Off Label Use2.7%91
14
Depression2.6%89
15
Malaise2.5%86

These are voluntary reports and do not establish that zaleplon caused these reactions.

Report severity

54.2%Serious1,857 reports
22.7%Hospitalizations779 reports
8.8%Fatal302 reports

Seriousness is determined by the reporter, not by OpenClaim.

Zaleplon drug interactions

Other drugs that appear in adverse event reports alongside zaleplon. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sodium-oxybate16.8%574
2
Quetiapine-fumarate4.2%145
3
Zolpidem-tartrate2.9%100
4
Eszopiclone2.6%90
5
Adalimumab2.5%85
6
Lenalidomide2.4%81
7
Oxycodone2.2%76
8
Esomeprazole2.1%73
9
Omeprazole2.0%69
10
Acetaminophen2.0%68
11
Lorazepam1.9%66
12
Gabapentin1.8%62
13
Clonazepam1.8%60
14
Bupropion1.7%59
15
Mirtazapine1.5%52

Taken alongside

1
Acetaminophen23.1%793
2
Ergocalciferol16.6%568
3
Gabapentin16.0%547
4
Levothyroxine-sodium14.8%507
5
Zolpidem-tartrate13.6%465
6
Aspirin13.2%452
7
Hydrocodone12.3%423
8
Alprazolam12.2%419
9
Clonazepam12.0%412
10
Albuterol11.9%406
11
Fluticasone11.6%397
12
Omeprazole11.5%394
13
Oxycodone11.3%386
14
Ibuprofen10.2%349
15
Atorvastatin-calcium10.1%346

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports zaleplon side effects

61.3% of zaleplon adverse event reports involve female patients and 29.6% involve male patients. The largest age group is adult at 72%. These figures reflect who reports side effects, not underlying risk.

Sex

Female61.3%
Male29.6%
Unknown9.0%

Age group

< 20.0%
2–11<0.1%
12–171.1%
18–6471.9%
65+26.9%

What is zaleplon used for

Conditions and purposes for which patients were taking zaleplon when the adverse event was reported.

AnxietyArthralgiaAnxietyBipolar Affective Disorder, MixedBipolar DisorderBipolar I DisorderCataplexyCircadian Rhythm Sleep DisorderCompleted SuicideCoughCerebral InfarctionDelayed Sleep PhaseDepressionDizzinessDrug Use For Unknown Indication

Showing 15 of 61 indications

Zaleplon brand names and reporting trend

Zaleplon is sold under the brand name Zaleplon.

Brand names

Zaleplon1,650

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking zaleplon with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.