Ramelteon oral tablet side effects: A detailed guide

This article describes possible side effects of ramelteon oral tablet. You can explore this overview article to learn more about ramelteon, including the drug’s uses, ways to save on cost, and more.

Ramelteon oral tablet is a generic version of the brand-name drug Rozerem.

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More common side effects of ramelteon

Ramelteon oral tablet may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of ramelteon oral tablet include:

• drowsiness (sleepiness)*
• dizziness
• fatigue (low energy)
• nausea
• worsening insomnia (trouble sleeping)

* To learn more about this side effect, see the “Side effects of ramelteon in detail” section below.

Mild side effects of ramelteon

Ramelteon may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of ramelteon oral tablet that occurred in studies include:

• drowsiness (sleepiness)*
• fatigue (low energy)
• dizziness
• nausea
• worsening insomnia (trouble sleeping)
• mild allergic reaction*

Ramelteon oral tablet may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

* To learn more about this side effect, see the “Side effects of ramelteon in detail” section below.

Serious side effects of ramelteon

Ramelteon may cause certain serious side effects. If you have any serious side effects from ramelteon oral tablet, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with ramelteon.

Serious side effects of ramelteon oral tablet that occurred in studies include:

• changes in behavior and thinking, including bizarre behavior, agitation, and mania
• suicidal thoughts or behavior
• worsening depression
• hallucinations (seeing or hearing something that’s not really there)
• memory loss
• anxiety
• atypical behaviors while asleep*
• hormonal changes*
• severe allergic reaction*

* To learn more about this side effect, see the “Side effects of ramelteon in detail” section below.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Text Line at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

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Common questions about side effects of ramelteon

Here are answers to some common questions about side effects of ramelteon oral tablet. If you have other questions, talk with your doctor or pharmacist.

How do the side effects of ramelteon compare with those seen with melatonin?

Ramelteon and melatonin are both taken to help with sleep. However, ramelteon is a prescription drug while melatonin is an over-the-counter dietary supplement.

Melatonin typically isn’t linked to any serious side effects. And it hasn’t been shown to cause dependence or withdrawal. (With dependence, your body needs the drug to feel like it usually does. Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on.)

It may cause general side effects, including dizziness, headache, and nausea. But it’s unclear whether these symptoms are linked directly to melatonin.

In comparison, ramelteon has the potential to cause several serious side effects, including hallucinations (seeing or hearing things that aren’t really there), suicidal thoughts or behavior, and memory loss. It can also cause mild side effects such as sleepiness, fatigue (low energy), dizziness, and nausea.

If you have more questions about how the side effects of ramelteon compare with those of melatonin, talk with your doctor.

Is weight gain a side effect of ramelteon?

Typically no. Weight gain wasn’t reported in studies of ramelteon. But this doesn’t mean weight gain can’t occur or won’t be reported with ramelteon sometime in the future.

If you take ramelteon and have concerns about your weight, talk with your doctor.

Does ramelteon cause long-term side effects?

Yes, in some cases ramelteon oral tablet may cause long-term side effects. These can last for a while after you’ve stopped taking the drug.

Examples of long-term side effects reported with ramelteon oral tablet include:

• hormonal changes
• worsening depression
• suicidal thoughts or behavior

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of ramelteon may last.

Side effects of ramelteon in detail

Below you’ll find details on some of the side effects of ramelteon oral tablet.

Drowsiness

In studies, drowsiness (sleepiness) was common in people taking ramelteon oral tablet. This side effect is usually mild.

You can still feel drowsy the next day after taking ramelteon. Due to this risk, you shouldn’t drive or do any activities that require concentration until you feel fully awake.

Certain factors can increase the risk of drowsiness with ramelteon oral tablet. These include:

• drinking alcohol
• taking other medications that make you feel drowsy
• taking certain other medications that increase the levels of ramelteon in your body

Ways to manage

If you have concerns about drowsiness with ramelteon, tell your doctor. They can discuss strategies to minimize drowsiness, or they can discuss alternative treatments for insomnia.

Abnormal behaviors while asleep

Ramelteon oral tablet can cause you to get out of bed while asleep and do an activity you aren’t aware you’re doing. Examples include:

• sleep driving
• cooking or eating food
• having sex

When this happens, you typically won’t remember the event.

Certain factors can increase the risk of atypical sleep behaviors with ramelteon oral tablet. These include alcohol use and taking other drugs that cause atypical sleep behaviors.

Ways to manage

Avoid drinking alcohol or taking other medications that make you sleepy while you’re taking ramelteon oral tablet. If you experience an atypical event while asleep, tell your doctor. They’ll likely recommend that you stop taking ramelteon.

Hormonal changes

Ramelteon oral tablet can cause changes to certain hormones in the body, including testosterone and prolactin. This can cause symptoms such as:

• difficulty getting pregnant
• irregular or no menstruation
• decreased interest in sex
• leakage of milk from the nipples (in someone who isn’t breastfeeding)

Ways to manage

If you experience symptoms of hormonal changes, tell your doctor. They may recommend treatment. And they can determine whether you should stop taking ramelteon.

Allergic reaction

For some people, ramelteon oral tablet can cause an allergic reaction.

Symptoms can be mild or serious, and they may include:

• itchiness
• skin rash
• swelling under the skin, typically affecting eyelids, lips, hands, or feet
• swelling of the mouth, tongue, or throat, which can make it hard to breathe
• flushing (temporary warmth, redness, or deepening of skin color)

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to ramelteon oral tablet, your doctor may recommend taking a different medication instead.

Warnings for ramelteon

Below are some factors you may want to discuss with your doctor before taking ramelteon oral tablet.

Warnings

It may not be safe for you to take ramelteon oral tablet if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether ramelteon oral tablet is a safe treatment option for you.

Before taking ramelteon oral tablet, tell your doctor about your health and medications you take. Things to consider include:

• history of mental health conditions
• history of liver disease
• lung or breathing problems, including severe sleep apnea
• taking other medications that make you drowsy
• past allergic reaction to ramelteon

Ramelteon and pregnancy

It’s not known whether ramelteon oral tablet should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Ramelteon and breastfeeding

It’s not known whether ramelteon oral tablet should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Ramelteon and alcohol

Ramelteon oral tablet isn’t known to interact with alcohol.

But it’s not recommended to drink alcohol while taking ramelteon. Ramelteon and alcohol can both cause drowsiness and dizziness when taken alone.

They can also make it difficult to think, focus, and react. If they’re taken together, the risk of these side effects increases.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with ramelteon oral tablet.

What to ask your doctor

This article describes common and serious side effects of ramelteon oral tablet. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

Here’s a list of some possible questions you may want to ask your doctor:

• Do I have a higher risk of hormonal changes than others?
• Is the risk of suicidal thoughts or behaviors highest when I first start treatment?
• How can ramelteon worsen my insomnia?

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.