Ramelteon

Introduction

Written by Helen Marshall BPharm MRPharmS
Medically reviewed by Victor Nguyen, PharmD, MBA
Updated on September 26, 2023

Ramelteon (ra MEL tee on) is a generic medication prescribed for insomnia in adults. Ramelteon belongs to a group of drugs called melatonin receptor agonists.

Side effects of ramelteon

Ramelteon may cause mild or serious side effects. More common mild side effects of ramelteon and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about ramelteon’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for ramelteon listed in the “Resources” section.

Mild side effects

More common mild side effects reported with ramelteon are listed below.

This article doesn’t include all possible mild side effects of the drug. To learn more about ramelteon’s side effects, refer to the prescribing information for ramelteon listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Ramelteon oral tablet’s mild side effects include:

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

* For details about this side effect, see the “Interactions and warnings for ramelteon” section.

Serious side effects

Serious side effects of ramelteon are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about ramelteon’s side effects, refer to the prescribing information for ramelteon listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, ramelteon’s serious side effects include:

• doing activities while asleep, such as sleepwalking, driving, preparing and eating food, making phone calls, or having sex
• memory loss
• hallucinations (seeing or hearing things that aren’t real)
• anxiety, agitation, or unusual behavior
• worsening of depression or suicidal thoughts
• change in levels of sex hormones, such as reduced testosterone or raised prolactin levels
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for ramelteon” section.

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 Textline 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.

Common questions about ramelteon

Below you’ll find answers to a few commonly asked questions about ramelteon.

Is ramelteon similar to melatonin?

Yes, ramelteon is similar to melatonin. Melatonin is a natural hormone that promotes sleep. Ramelteon is a type of drug called a melatonin receptor agonist. It acts on the same sites in your brain as melatonin. It has the same sleep-inducing effect as melatonin.

If you have questions about this, talk with your doctor or pharmacist.

Does ramelteon cause weight gain?

No, ramelteon isn’t known to cause weight gain. Weight gain wasn’t reported in studies of ramelteon.

But ramelteon can sometimes cause unusual behavior while sleeping. For example, some people who take ramelteon may prepare and eat food while asleep. When you wake in the morning, you may not remember doing this. If you often have this experience while taking ramelteon, this could lead to weight gain.

If you have unexplained or bothersome weight gain while taking ramelteon, talk with your doctor. They can help figure out the possible cause.

Is ramelteon available over the counter?

No, ramelteon is not available over the counter. You’ll need a doctor’s prescription to get this medication.

Talk with your doctor if you have questions about ramelteon.

How does ramelteon work? And how long does it take to start working?

Ramelteon works by acting on the same sites in your brain as the natural hormone melatonin. It produces the same effects as this hormone.

Melatonin manages your sleep-wake cycle. Your body usually produces more melatonin in the evening, and this helps you fall asleep. When you take ramelteon at bedtime, it adds to the effect of your natural melatonin. This helps you fall asleep faster and makes it less likely that you’ll wake up in the night.

Ramelteon may take about 30–90 minutes to start working.

If you’d like to know more about this, talk with your doctor or pharmacist.

Uses of ramelteon

The Food and Drug Administration (FDA) approves prescription drugs such as ramelteon for certain conditions. Approved uses for ramelteon are described below.

Use for insomnia

Doctors may prescribe ramelteon oral tablet for treating sleep-onset insomnia. It’s used for this purpose in adults. It may be prescribed as a long-term or short-term treatment.

With sleep-onset insomnia, you have trouble falling asleep. You may also have trouble staying asleep. As a result, you don’t get enough refreshing sleep. This may mean you have low energy and trouble functioning during the day.

Ramelteon helps you fall asleep faster so you can get more sleep. You’ll take it just before going to bed.

Interactions and warnings for ramelteon

Below you’ll find information about ramelteon’s possible interactions and warnings.

Interactions of ramelteon

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol* or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take ramelteon, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for ramelteon” section below.

* It’s recommended that you do not consume alcohol while taking ramelteon. Talk with your doctor if you have concerns about avoiding alcohol during ramelteon treatment.

Warnings for ramelteon

Some people should not take ramelteon, and others should take it cautiously.

Ramelteon could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether ramelteon is a safe option for you.

Ask your doctor about specific warnings for ramelteon, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Ramelteon can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to ramelteon or any of its ingredients, your doctor will likely not prescribe ramelteon. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to ramelteon, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of ramelteon

You should not take more ramelteon than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much ramelteon, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and ramelteon

Information about ramelteon and pregnancy and breastfeeding is described below.

Ramelteon and pregnancy

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

What to ask your doctor

Let your doctor know if you have questions about ramelteon or would like more details about it.

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

• Is it possible to become dependent on ramelteon?
• How does ramelteon compare with other insomnia treatments?
• Can I take ramelteon with my other medications?

Resources

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Ramelteon tablets, for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/01dfc4c5-07d1-4dd7-a9ca-a94203b2e16d/spl-doc

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.