Pronunciation:

ra-MEL-tee-on

Brand Names:

• Rozerem

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Nonbarbiturate Hypnotic

Pharmacologic—

Melatonin Receptor Agonist

Uses of This Medicine:

Ramelteon belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Ramelteon is used to treat insomnia (trouble in sleeping). Ramelteon helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ramelteon in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ramelteon in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Calcium Oxybate
• Fluvoxamine
• Magnesium Oxybate
• Potassium Oxybate
• Sodium Oxybate
• Viloxazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butorphanol
• Cannabidiol
• Cannabis
• Capmatinib
• Carbinoxamine
• Cetirizine
• Clobazam
• Clonazepam
• Codeine
• Daridorexant
• Dexmedetomidine
• Dihydrocodeine
• Doxylamine
• Esketamine
• Fentanyl
• Flibanserin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Givosiran
• Hydrocodone
• Hydromorphone
• Itraconazole
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Meclizine
• Meperidine
• Methadone
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oxycodone
• Oxymorphone
• Pacritinib
• Pentazocine
• Periciazine
• Phenobarbital
• Pregabalin
• Primidone
• Propofol
• Remifentanil
• Remimazolam
• Ritlecitinib
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Sufentanil
• Tapentadol
• Tocilizumab
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Donepezil
• Doxepin
• Fluconazole
• Ketoconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Mental depression, history of or
• Sleep apnea (temporary stopping of breathing during sleep)—Ramelteon may make these conditions worse.

• Liver disease, moderate—Higher blood levels of ramelteon may result, increasing the chance of side effects.

• Liver disease, severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

It is best to take this medicine no more than 30 minutes before you go to bed. After you take the medicine do not engage in any activity besides getting ready for bed.

Do not take this medicine with or right after a meal.

Swallow the tablet whole. Do not break it.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing—

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.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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

Some side effects 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:

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.