Rozeremramelteon
According to the FDA label: Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14) ] .
7,279 adverse event reports submitted to the FDA (2005–2026)
Top Reported Adverse Events
The most frequently reported events in association with Rozerem in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 914 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Initial Insomnia 447 reports
Somnolence 415 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Insomnia 395 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →- Middle Insomnia 390 reports
Nausea 332 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 287 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dizziness 271 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Headache 257 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 238 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →- Poor Quality Sleep 218 reports
Diarrhoea 214 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Feeling Abnormal 207 reports
A general report that the person did not feel like themselves, without a more specific description.
Full definition in the glossary →Fall 206 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Anxiety 191 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 3,895 |
| Male | 2,760 |
| Unknown | 88 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 312 |
| 18-34 | 436 |
| 35-49 | 777 |
| 50-64 | 1,181 |
| 65-74 | 866 |
| 75+ | 1,220 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Rozerem. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 3,282 |
| Other Serious | 2,555 |
| Hospitalization | 2,066 |
| Death | 796 |
| Life-Threatening | 373 |
| Disability | 148 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Rozerem. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2005 | 80 |
| 2006 | 743 |
| 2007 | 1,151 |
| 2008 | 601 |
| 2009 | 115 |
| 2010 | 204 |
| 2011 | 214 |
| 2012 | 200 |
| 2013 | 156 |
| 2014 | 176 |
| 2015 | 348 |
| 2016 | 408 |
| 2017 | 423 |
| 2018 | 380 |
| 2019 | 383 |
| 2020 | 281 |
| 2021 | 311 |
| 2022 | 248 |
| 2023 | 258 |
| 2024 | 248 |
| 2025 | 300 |
| 2026 (partial) | 51 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Rozerem
In FDA adverse event reports that mention Rozerem, these medications appeared most often in the same report.
- Zolpidem (645 reports)
- Furosemide (581 reports)
- Quetiapine (538 reports)
- Clonazepam (503 reports)
- Gabapentin (480 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026