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Ramelteon Side Effects

It is possible that some side effects of ramelteon may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ramelteon: oral tablet

As well as its needed effects, ramelteon may cause unwanted side effects that require medical attention.

Some ramelteon side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Dizziness
  • sleepiness or unusual drowsiness
Less common
  • Body aches or pain
  • change in taste
  • chills
  • cough
  • difficulty in breathing
  • difficulty in moving
  • discouragement
  • ear congestion
  • fatigue
  • feeling sad or empty
  • fever
  • general feeling of discomfort or illness
  • irritability
  • joint pain
  • loss of appetite
  • loss of interest or pleasure
  • loss of taste
  • loss of voice
  • muscle aching or cramping
  • muscle pain or stiffness
  • nasal congestion
  • nausea
  • pain in joints
  • runny nose
  • shivering
  • sleeplessness
  • sneezing
  • sore throat
  • sweating
  • swollen joints
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

Applies to ramelteon: oral tablet


Common (1% to 10%): Exacerbated insomnia
Frequency not reported: Behavioral changes, complex behaviors, amnesia, hallucinations, anxiety[Ref]

Nervous system

Common (1% to 10%): Somnolence, dizziness[Ref]


Rare (less than 0.1%): Severe anaphylactic and anaphylactoid reactions (e.g., angioedema)[Ref]


Common (1% to 10%): Nausea[Ref]


Common (1% to 10%): Fatigue[Ref]


1. "Product Information. Rozerem (ramelteon)." Takeda Pharmaceuticals America, Lincolnshire, IL.

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