Ramelteon (Rozerem) - Oral

What Is Rozerem?

Rozerem (ramelteon) is an oral prescription medication used to treat insomnia. Rozerem belongs to a group of drugs called melatonin receptor agonists. It binds to and activates the same receptors in your brain as melatonin—a naturally occurring substance that promotes sleep.

Drug Facts

Generic Name: Ramelteon

Brand Name(s): Rozerem

Drug Availability: Prescription

Therapeutic Classification: Melatonin receptor agonist

Available Generically: Yes

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Ramelteon

Dosage Form(s): Tablet

What Is Rozerem Used For?

Rozerem is used to treat sleep-onset insomnia—a type of insomnia that makes it hard for you to fall asleep. Your healthcare provider may prescribe Rozerem to help you fall asleep faster.

Between 10% and 30% of adults and 30% and 48% of older adults have experienced insomnia. Females have a risk of insomnia around 40% higher than males.

Data show the following groups experience shorter sleep duration: Native Hawaiians/Pacific Islanders (46.3%), non-Hispanic blacks (45.8%), multiracial non-Hispanics (44.3%), and American Indians/Alaska Natives (40.4%) compared with non-Hispanic whites (33.4%), Hispanics (34.5%), and Asians (37.5%). 

Adults who get seven or fewer hours of sleep in 24 hours may be more likely to be obese, physically inactive, and smoke tobacco compared to people who get seven or more hours of sleep in a 24-hour period.

How to Take Rozerem

You should take your prescribed dose of Rozerem 30 minutes before going to bed. Be sure to swallow the Rozerem tablet whole—do not break, crush, or chew. After taking Rozerem, only do activities needed to get ready for bed. You should only take Rozerem if you will be able to get a full night’s sleep before you need to be active again. 

Food can affect how your body absorbs Rozerem, so avoid taking Rozerem with a meal or right after eating. Alcohol should also be avoided since it can increase your risk of developing side effects from Rozerem.

Storage

Store Rozerem at room temperature in a tightly-closed container, protected from humidity.

Keep your medications tightly closed and out of the reach of children and pets, ideally locked in a cabinet or closet.

Avoid pouring unused and expired drugs down the drain or in the toilet. Ask your pharmacist or healthcare provider about the best ways to dispose of this medicine. Visit the Food and Drug Administration's (FDA) website to know where and how to discard all unused and expired drugs. You can also find disposal boxes in your area. Ask your pharmacist or healthcare provider if you have any questions about the best ways to dispose of your medications.

If you travel with Rozerem, get familiar with your final destination's regulations. In general, be sure to make a copy of your Rozerem prescription. Keep your medication in its original container from your pharmacy with your name on the label. Ask your pharmacist or healthcare provider if you have any questions about traveling with your medicine.

How Long Does Rozerem Take to Work?

Rozerem starts working quickly, so be sure only to take it when you’re ready to sleep. You should begin to feel tired within 30 minutes of taking your dose. Let your healthcare provider know if your symptoms don’t get better or worsen within seven to 10 days. This could mean you have another condition causing your insomnia.

Off-Label Uses

Off-label uses of Rozerem include circadian rhythm sleep disorders (i.e., jet lag, shift-work) and ICU-related delirium.

What Are the Side Effects of Rozerem?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

You may experience side effects from Rozerem. Be sure to let your healthcare provider know if you develop any side effects that bother you or don’t go away. Common side effects include:

  • Dizziness 
  • Drowsiness 
  • Tiredness

You may feel drowsy the next day after taking Rozerem. Be careful not to drive or do any other dangerous activity until you feel fully awake.

Severe Side Effects

Rarely, Rozerem may cause severe side effects. Call your healthcare provider right away if you have a serious reaction. Call 911 if your symptoms feel life-threatening or you think you’re having a medical emergency. Serious side effects and their symptoms include:

  • Severe allergic reactions: Seek medical care right away if you develop swelling of the tongue or throat, trouble breathing, nausea, or vomiting. 
  • Abnormal thinking or changes in behavior: Rozerem may cause worsening depression, suicidal thoughts or behaviors, nightmares, hallucinations (seeing or hearing things that are not there), agitation, or mania. Let your healthcare provider know if you notice any changes in your mood.
  • Performing activities while asleep: Rozerem may cause you to get out of bed and do things you don’t remember doing the following day. The chance of this happening increases if you drink alcohol or take other drugs that make you sleepy with Rozerem.

Performing activities while asleep: Rozerem may cause you to get out of bed and do things you don’t remember doing the next morning. The chance of this happening increases if you drink alcohol or take other drugs that make you sleepy with Rozerem. Activities include:

  • Driving a car (“sleep-driving”)
  • Having sex
  • Making or eating food 
  • Sleep-walking 
  • Talking on the phone

Rozerem may cause hormonal changes. Rozerem can decrease testosterone levels and increase prolactin levels. Signs of these hormonal changes include:

  • Decreased sex drive
  • Irregular menstrual cycles or no menstrual cycles 
  • Milk production and leakage from the nipples of a person who is not breastfeeding 
  • Problems getting pregnant

Long-Term Side Effects

Long-term side effects may include issues with vasomotor control activity in the brain, immune and hormonal system outcomes, and reproduction.

Report Side Effects

Rozerem may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Rozerem Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For the treatment of insomnia (trouble in sleeping):
      • Adults—8 milligrams (mg) at bedtime.
      • Children—Use and dose must be determined by your doctor.

Modifications

The following modifications (changes) should be kept in mind when using Rozerem:

Severe allergic reaction: Avoid using Rozerem if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: In animal studies, Rozerem was found to affect the fetus. Discuss with your healthcare provider if you plan to become pregnant or are pregnant, and weigh the benefits and risks of taking Rozerem during your pregnancy.

Breastfeeding: In animal studies, Rozerem was present in rat's breastmilk. If a drug is present in animal milk, it will likely be in human milk. Rozerem can cause sleep in breastfed infants. Talk with your healthcare provider if you plan to breastfeed, weigh the benefits and risks of taking Rozerem while nursing, and the different ways available to feed your baby.

Adults over 65: Clinical studies haven't included a large enough number of people in this age group to see whether they respond differently to Rozerem than younger adults.

Children: The safety and effectiveness of Rozerem have not been established in children.

Liver problems: Individuals with liver problems may not be able to clear medication from their bodies as easily. This means the medicine stays in the body longer and can have increased side effects. For this reason, your healthcare provider may not prescribe Rozerem if you have severe liver impairment. If you have moderate liver impairment, your healthcare provider will likely not prescribe Rozerem beyond a certain dosage.

Missed Dose

It would be best if you only took Rozerem at night before sleep. If you forget to take your dose and you haven’t gone to sleep yet, you can take Rozerem if you will be able to sleep for seven to eight hours.

Try to find ways that work for you to help yourself remember to keep your appointments and take your medication routinely.

Overdose: What Happens If I Take Too Much Rozerem?

Taking too much Rozerem may cause you to feel drowsy or dizzy. Researchers studying the effects of high-dose Rozerem did not observe any serious reactions. Still, it’s important only to take your prescribed dose of Rozerem, and avoid alcohol or other sedating medications, since taking these together could increase side effects.

Call your healthcare provider or the Poison Control center if you’ve taken more than your prescribed dose of Rozerem. If your symptoms feel life-threatening, call 911.

What Happens If I Overdose on Rozerem?

If you think you or someone else may have overdosed on Rozerem, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Rozerem, call 911 immediately.

Precautions

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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 this medicine 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.

What Are Reasons I Shouldn’t Take Rozerem?

Certain conditions increase your risk of developing complications from Rozerem. Your healthcare provider will likely choose a different insomnia treatment if you:

  • Have had a serious allergic reaction to Rozerem in the past
  • Take fluvoxamine (an SSRI antidepressant medicine)
  • Have severe liver impairment

What Other Medications Interact With Rozerem?

Many medications may interact with Rozerem. Let your healthcare provider know about all your medicines, including over-the-counter (OTC) nonprescription products like herbal products and supplements. 

Certain medicines should never be taken with Rozerem, including the antidepressant fluvoxamine, since it can significantly increase levels of Rozerem in your body.

Other medications can also affect Rozerem levels. Let your healthcare provider know if you take:

  • Aricept (donepezil) 
  • Certain HIV medications
  • Clarithromycin 
  • Diflucan (fluconazole) 
  • Ketoconazole 
  • Nefazodone 
  • Noxafil (posaconazole)
  • Qelbree (viloxazine) 
  • Rifampin
  • Silenor (doxepin) 
  • Sporanox (itraconazole)
  • Vfend (voriconazole)

Watch out for any medicines that make you feel sleepy. Taking sedating drugs with Rozerem can increase your risk of side effects. Sedating drugs include:

This is not a complete list of all the drugs that may interact with Rozerem.

What Medications Are Similar?

Rozerem is the only melatonin receptor agonist used to treat insomnia. It binds to the same receptors in the brain as melatonin—a naturally occurring substance that promotes sleep.Melatonin is available as an OTC, nonprescription product, but its effects are limited since it is rapidly cleared from the body. Rozerem has the advantage of being longer acting compared with melatonin.

Frequently Asked Questions

  • What is Rozerem used for?

    Rozerem is used to treat sleep-onset insomnia—a type of insomnia that makes it hard for you to fall asleep. Rozerem can help you fall asleep faster.

  • How does Rozerem work?

    Rozerem belongs to a class of medications called melatonin receptor agonists. Rozerem works by binding to melatonin receptors in the brain and producing similar effects to melatonin—a naturally occurring substance that promotes sleep.

  • What drugs should not be taken with Rozerem?

    The antidepressant medicine fluvoxamine should never be taken with Rozerem. You should also avoid alcohol and other medicines that make you feel sleepy. Let your healthcare provider know about all the drugs to take, so they can ensure Rozerem is a safe option for you.

  • How long does it take for Rozerem to work?

    You should begin to feel the effects of Rozerem within 30 minutes. Because Rozerem starts to work fast, only take Rozerem when you are ready to go to sleep.

  • What are the side effects of Rozerem?

    The most common side effects of Rozerem include drowsiness, tiredness, and dizziness.

How Can I Stay Healthy While Taking Rozerem?

If you’re struggling with insomnia, the anxiety of lying awake wondering how you’ll be able to get through the next day is an all too common experience. Fortunately, effective medications like Rozerem are available to help you fall asleep and get the rest you need.

Be sure to talk to your healthcare provider about non-pharmacologic options, including good sleep hygiene practices and cognitive behavioral therapy. Using these methods along with medications may help you achieve the best results.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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By Christina Varvatsis, PharmD
Christina Varvatsis is a hospital pharmacist and freelance medical writer. She is passionate about helping individuals make informed healthcare choices by understanding the benefits and risks of their treatment options.