Brand name · Doxylamine succinate
Unisom SleepTabs: adverse event reports filed with FDA
1,559 reports list it as a suspect or interacting product, 2011–2026. Class: Antihistamine.
- 1,559
- reports as suspect product
- 0% of all reports · about 104 a year
- 87
- reports, 12 months to June 2026
- 78 in the 12 months before
- 7.6%
- marked serious by the reporter
- 74.8% across the class
- 0.5%
- record death among outcomes, as reported
- 8 reports · not verified by FDA
1,559 adverse event reports received by FDA list the brand name Unisom SleepTabs (doxylamine succinate) as a suspect or interacting product, from July 2011 to April 2026. A further 492 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 87 reports listed it, up 12% from 78 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 104 reports a year and 0% of the 20,646,523 reports in the database, and 9.9% of the reports for the antihistamine class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (29.6%), somnolence (12%) and underdose (7.4%). A report can list several reactions, so shares add to more than 100%; 146 different terms appear across these reports. Drug ineffective is recorded in 29.6% of these reports, a larger share than in the median antihistamine drug (8.6%).
7.6% of the reports are marked serious by the reporter (74.8% across the class); 0.5% record death among the outcomes and 1.4% record hospitalisation, as reported. 96.5% of the reports came from consumers, and the largest patient age group is 75 and over (4.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Unisom SleepTabs reports recording the termmedian drug in antihistamine
- Drug ineffectivethe medicine did not work as expected29.6%462
- Somnolencedrowsiness12%187
- Underdoseless than the intended dose7.4%115
- Maternal exposure during pregnancythe mother took the medicine during pregnancy7.2%113
- Insomniadifficulty sleeping4.4%68
- Incorrect dose administeredthe wrong dose was given4.1%64
- Exposure during pregnancythe medicine was taken during pregnancy3.2%50
- Feeling abnormalfeeling odd or not right3.1%49
- Fatiguetiredness3%47
- Dizzinesslight-headedness or unsteadiness2.4%37
- Nightmarenightmares2.3%36
- Overdosea dose above the recommended amount2%31
- No adverse eventno adverse event was reported1.7%27
- Wrong technique in product usage processthe product was used in the wrong way1.7%27
- Off label useused for a purpose or in a way not on the label1.6%25
- Hangover1.3%21
- Headachehead pain1.3%21
- Restless legs syndrome1.3%21
- Product administration errora mistake in giving the product1.3%20
- Therapeutic product effect variable1.1%17
- Abnormal dreamsunusual dreams1%15
- Drug dependencedependence on a medicine1%15
- Therapeutic product effect delayed0.9%14
- Dry mouthdry mouth0.8%12
Top 30 of 146 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the antihistamine class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 15,698 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Insomnia | 485 | 31.1% |
| Sleep disorder | 48 | 3.1% |
| Morning sickness | 40 | 2.6% |
| Nausea | 37 | 2.4% |
| Accidental exposure to product by child | 22 | 1.4% |
| Accidental exposure to product | 4 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,559 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Unisom SleepTabs reports |
|---|---|---|
| Melatonin | 15 | 1% |
| Benadryl | 5 | 0.3% |
| Gabapentin | 5 | 0.3% |
| Tylenol | 5 | 0.3% |
Other products listed in reports where Unisom SleepTabs is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Unisom SleepTabs | Antihistamine | All reports |
|---|---|---|---|
| Reports as suspect product | 1,559 | 15,698 | 20,646,523 |
| Share of that pool | — | 9.9% | 0% |
| Reports, latest 12 months | 87 | — | 1,332,454 |
| Marked serious | 7.6% | 74.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 5 | 352 | 91 |
| Hospitalisation recorded, per 1,000 reports | 14 | 291 | 213 |
| Consumer-filed share | 96.5% | 26.5% | 45.8% |
| Top term, share of reports | Drug ineffective 29.6% | median 8.6% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the antihistamine class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Hydroxyzine | generic | 8,643 | 907 | 92.5% |
| Hydroxyzine hydrochloride | generic | 2,500 | 417 | 83.4% |
| Doxylamine succinate | generic | 1,858 | 252 | 43.3% |
| Hydroxyzine pamoate | generic | 1,138 | 73 | 65.8% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Unisom SleepTabs reports
How many adverse event reports has FDA received for Unisom SleepTabs?
1,559 reports list Unisom SleepTabs as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 87 of them arrived in the latest 12 months. Another 492 list it only as a concomitant medication.
What reactions are recorded in Unisom SleepTabs reports?
drug ineffective (29.6%), somnolence (12%), underdose (7.4%), maternal exposure during pregnancy (7.2%) and drug effective for unapproved indication (4.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Unisom SleepTabs was responsible.
How serious are the reports?
7.6% are marked serious by the reporter. Among the outcomes recorded, 0.5% of reports include death and 1.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (96.5%), other health professional (1.8%) and not given (1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Unisom SleepTabs rising?
87 reports in the 12 months to June 2026, up 12% from 78 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Unisom SleepTabs was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Unisom SleepTabs?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Unisom SleepTabs as a suspect or interacting product; reports listing it only as a concomitant medication (492) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.