1 What is Rozerem?

Brand: Rozerem

Generic: Ramelteon

Rozerem is a prescription-only medicine that helps to induce or maintain your sleep. So, it is used in patients with insomnia (sleep problems).

It is a member of a class of medicines called central nervous system (CNS) depressants, agents that downregulate functions of your brain and spinal cord.

Using ramelteon or other similar medicines for more than 1 or 2 weeks is not recommended. It is available in a tablet form.

2 What to Know Before Using

Before using Rozerem, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will do you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.

Pediatric: Safety and efficacy of ramelteon in children have not been studied extensively. Consult your child’s doctor before using.

Geriatric: It may be used in elderly after assessing risks and benefits of the use.

Pregnancy: It falls under pregnancy category C for all trimesters, meaning that due to lack of sufficient studies, it’s not clear if this medication is safe for use in pregnancy.

Breastfeeding: It may be used in a nursing mother after assessing risks and benefits of the use.

Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions.

Here is a list of the medicines which in general are not recommended to be used with ramelteon.

Inform your doctor if you are using any of these medicines:

  • Fluvoxamine
  • Sodium Oxybate

Though usually not recommended, your doctor may decide, after adjusting dose or frequency of one or both medicines, to use this medicine with any of the following medicines:

  • Bromazepam
  • Buprenorphine
  • Carbinoxamine
  • Fentanyl
  • Flibanserin
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Meclizine
  • Methadone
  • Morphine
  • Oxycodone
  • Oxymorphone
  • Propofol
  • Suvorexant
  • Tapentadol
  • Zolpidem

Rarely and only when absolutely needed, this medicine may be used with the following medicines even if using them together may put you at risk of certain side effects.

In such cases, you may have to take the adjusted dose or change the frequency of intake.

  • Donepezil
  • Doxepin
  • Fluconazole
  • Ketoconazole

• Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions. Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe.

Inform your doctor about the following conditions, if any:

  • Emphysema, asthma, bronchitis, or another chronic lung disease
  • Mental depression in the past
  • Sleep apnea (transient cessation of breathing during sleep): Use cautiously.
  • Moderate liver impairment: Use cautiously.
  • Severe liver impairment: Do not use ramelteon.

3 Proper Usage

To use Rozerem properly, you must follow all instructions given by your doctor.

  • Follow your doctor’s instructions and do not take more, less, more frequently or for a longer duration than recommended.
  • Read the medication guide carefully and follow accordingly. If you have any query, consult your doctor.
  • For better results, take this medicine within 30 minutes before sleep.
  • Do not chew, break or crush the tablet. Swallow the entire tablet with enough water.
  • Taking this medicine with or just after a meal is not recommended.

Dosing: For best results, follow your doctor to know what amount of medicine you should take in a single dose. The doses of a medicine can differ according to the conditions for which it is being prescribed. Remember your doses can differ.

Consult your doctor if you have anything to ask. The doses of tablet for:

Treating insomnia (problem falling asleep or maintaining sleep):

  • Adults: 8 milligrams (mg) before sleep.
  • Children: Your doctor will decide the use and dose.

Missed Dose: Take your missed dose once you remember but avoid it if it’s time to take your next dose, and follow your normal dosing schedule.

Avoid taking double doses to make up for the missed dose. Do not miss more than a dose. If you do, call your doctor before restarting it.


  • Store in a closed container at room temperature.
  • Keep away from heat, moisture, and direct light.
  • Do not freeze.
  • Keep away from children.
  • Discard any unused or expired medicines.

4 Precautions to Take

In using Rozerem, you must be careful and take some precautions as advised by your doctor. If your insomnia lasts more than a week after treatment, consult your doctor to determine any underlying causes.

Consult your doctor if:

  • Your symptoms worsen.
  • You engage in any activities such as driving, walking, or eating food while in sleep or half-awake.
  • You notice unusual menstrual cycle or drainage from the nipple (females), and reduced sex drive.
  • You behave like being drunk or have other serious signs such as confusion, depressive or suicidal thoughts, hallucinations, and mania, nervousness, or irritability.

Discontinue the medicine and seek emergency medical help if you develop any symptoms of serious allergic reaction (anaphylaxis), including itching, welts, breathing difficulties, or swollen hands, face, or mouth.

Do not take ramelteon and fluvoxamine together. Do not drink alcohol during treatment with ramelteon. Take special care while driving or using machines, as it might cause dizziness or drowsiness.

Consult your doctor before taking any prescription or nonprescription medicines and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Rozerem. Mild and non-serious side effects usually go away on their own without requiring medical intervention.

You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including: 

More common:

Less common:

  • Generalized pain
  • Taste alterations
  • Chills
  • Cough
  • Breathing problems
  • Problem with movement
  • Congested ear
  • Tiredness
  • Depression
  • Fever
  • Aggression
  • Joint pain
  • Decreased appetite
  • Indifference
  • Speech problems
  • Stuffy nose
  • Tremors
  • Sneezing
  • Sore throat
  • Sweating
  • Inability to concentrate
  • Sleep problems
  • Excessive tiredness
  • Nausea and vomiting

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.

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