Ramelteon Tablets

What is this medication?

RAMELTEON (ram EL tee on) treats insomnia. It helps you go to sleep faster.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Rozerem

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• Lung or breathing disease, such as asthma or COPD
• Mental health condition
• Substance use disorder
• Sleep apnea
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to ramelteon, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label and only when you are ready for bed. Do not cut or break this medication. Swallow the tablets whole. Do not take it with or right after a meal.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Fluvoxamine
• Melatonin
• Tasimelteon
• Viloxazine

This medication may also interact with the following:

• Alcohol
• Certain medications for fungal infections like ketoconazole, fluconazole, or itraconazole
• Ciprofloxacin
• Donepezil
• Doxepin
• Other medications for sleep
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Plan to go to bed and stay in bed for a full night (7 to 8 hours) after you take this medication. You may still be drowsy the morning after taking this medication. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells.

You may do unusual sleep behaviors or activities you do not remember the day after taking this medication. Activities include driving, making or eating food, talking on the phone, sexual activity, or sleep walking. Stop taking this medication and call your care team right away if you find out you have done activities like this.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

After you stop taking this medication, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching, hives, swelling of the face, lips, tongue, arms, or legs, trouble swallowing or breathing
• High prolactin level—unexpected breast tissue growth, discharge from the nipple, change in sex drive or performance, irregular menstrual cycle
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Unusual sleep behaviors or activities you do not remember such as driving, eating, or sexual activity

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness the day after use
• Fatigue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.