Ramelteon Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 28, 2024.

Applies to ramelteon: oral tablet.

Precautions

Insomnia that lasts after 7 to 10 days of treatment may be a sign of another medical problem that should be evaluated. Consult your doctor if new or worsening signs of insomnia occur.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking ramelteon and call your doctor right away if you have itching, hives, trouble breathing, or any swelling of your hands, face, or mouth when you take this medicine.

Avoid drinking alcohol while using this medicine. Ramelteon will add to the effects of alcohol.

If you develop any unusual and strange thoughts or behavior while you are taking ramelteon, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. This medicine may also cause sleep-related behaviors such as sleep-driving, sleep-walking, having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.

If change of menstrual periods or discharge from your nipples (females); decreased interest in sex; or problems getting pregnant occur, be sure to discuss it with your doctor.

This medicine should not be used together with fluvoxamine (Luvox®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of ramelteon

Some side effects of ramelteon may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of ramelteon

Along with its needed effects, ramelteon may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

For healthcare professionals

Applies to ramelteon: oral tablet.

Psychiatric adverse events

• 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]

Immunologic

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

Gastrointestinal

• Common (1% to 10%): Nausea^[Ref]

Other

• Common (1% to 10%): Fatigue^[Ref]

See also:

Frequently asked questions

• What are the strongest sleeping pills?

Further information

Ramelteon side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer