What the label lists and what reports show
Zolpidem side effects
Zolpidem's FDA label lists its adverse reactions in its own words. FAERS holds 134,363 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 (8,548 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the zolpidem FDA label on DailyMed (effective August 15, 2022, Viatris Specialty LLC); 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 Edluar?Edluar may cause serious side effects, including: • getting out of bed while not being fully awake and doing an activity that you do not know you are doing. See “What is the most important information I should know about Edluar?” • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, suicidal thoughts or actions. • memory loss • anxiety • severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing. Get emergency medical help if you get these symptoms after taking Edluar. Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using Edluar. […]
Source: FDA drug label, Viatris Specialty LLC, effective August 15, 2022 (SPL set a32884d0-85b5-11de-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Complex Sleep Behaviors [see Warnings and Precautions (5.1) ] • CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2) ] • Serious Anaphylactic and Anaphylactoid Reactions [see Warning and Precautions (5.4) ] • Abnormal Thinking and Behavioral Changes [see Warning and Precautions (5.5) ] • Withdrawal Effects [see Warning and Precautions (5.8) ] Most commonly observed adverse reactions were: Short term (< 10 nights): Drowsiness, dizziness, and diarrhea Long term (28-35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-444-7799 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
TABLE 2: Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials with zolpidem tartrate lasting up to 35 nights (Percentage of patients reporting)
| Body System/ Adverse Event* | Zolpidem tartrate (≤ 10 mg) (N=152) | Placebo (N=161) |
|---|---|---|
| Autonomic Nervous System | 3 | 1 |
| Allergy | 4 | 1 |
| Back Pain | 3 | 2 |
| Influenza-like symptoms | 2 | - |
| Chest pain | 1 | - |
| Palpitation | 2 | - |
| Drowsiness | 8 | 5 |
| Dizziness | 5 | 1 |
| Lethargy | 3 | 1 |
| Drugged feeling | 3 | - |
| Lightheadedness | 2 | 1 |
| Depression | 2 | 1 |
| Abnormal dreams | 1 | - |
| Amnesia | 1 | - |
| Sleep disorder | 1 | - |
| Diarrhea | 3 | 2 |
| Abdominal pain | 2 | 2 |
| Constipation | 2 | 1 |
| Sinusitis | 4 | 2 |
| Pharyngitis | 3 | 1 |
| Rash | 2 | 1 |
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, Viatris Specialty LLC, effective August 15, 2022 (SPL set a32884d0-85b5-11de-8a39-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show?
134,363 reports list zolpidem among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15,992 are coded as a death and 46,181 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 20 reactions below, 11 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?
- Zolpidem: 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