The most commonly reported side effects of ramelteon include initial insomnia, middle insomnia, and somnolence, based on 7,323 FDA adverse event reports from 2005 to 2025. 9.1% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for ramelteon.
These are voluntary reports and do not establish that ramelteon caused these reactions.
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Other drugs that appear in adverse event reports alongside ramelteon. 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
Taken alongside
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.
53.5% of ramelteon adverse event reports involve female patients and 38.0% involve male patients. The largest age group is adult at 53%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking ramelteon when the adverse event was reported.
Showing 15 of 166 indications
Ramelteon is sold under the brand name Rozerem.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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