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Rozerem

Generic Name: Ramelteon [Ram-EL-teeon]
Drug class: Other anxiolytics (sedatives, hypnotics)

What is Rozerem?

Rozerem, or hypnotic sedatives, are used to treat insomnia. It affects certain substances that regulate your sleep-wake cycle. Rozerem can be used to treat insomnia, which is a problem with falling asleep. Rozerem, unlike some other sleep medications, is not habit-forming.

Warnings

Tell your doctor before taking Rozerem if you suffer from liver disease, sleep disorders such as chronic obstructive pulmonary disease, or depression. Rozerem should not be used if you also take fluvoxamine (Luvox) or if ramelteon has caused you to have a severe reaction. Rozerem can cause an allergic reaction. Seek emergency medical attention if you experience hives, difficulty breathing, nausea or vomiting, swelling of the face, lips, throat, tongue, or other parts. Take Rozerem 30 minutes prior to bedtime for optimal results. Do not do anything else after taking this medication. This medicine should not be taken with or immediately after a meal high in fat. It will be harder for the body to absorb this medication. This medicine can cause some people to forget what they did while using it. If this occurs, contact your physician immediately.

Before you take this drug

Rozerem can help you sleep. This medicine should not be taken during normal waking hours unless you can devote at least seven to eight hours to sleep.

Rozerem should not be used if you have an allergy to ramelteon or if

  • You have severe liver disease.
  • You should also take fluvoxamine.

Tell your doctor about any of the following to ensure that this medicine will be safe for you:

  • Liver disease
  • Breathing problems
  • Sleep Apnea occurs when breathing stops occurring while asleep.
  • Mental illness or suicidal ideas.

Inform your doctor if you are pregnant or nursing.

Do not breastfeed for 25 hours following the use of Rozerem. Throw away any milk collected if you are using a breast pump. Do not give it to your child. Ramelteon can affect levels of male and female hormones ( testosterone or prolactin). It can affect the menstrual cycle in women, male sexual desire, or fertility in both men and women. Rozerem cannot be used by anyone under the age of 18.

Similar/related drugs

Lorazepam, Melatonin, Zolpidem, Diphenhydramine, Ativan, and Ambien

How to take Rozerem?

Follow the directions on your prescription label and read all medication guides or instructions sheets. Read all instructions provided on the prescription label carefully. Take Rozerem 30 minutes before your normal bedtime. Do not chew or crush the tablet. It is not recommended to take Rozerem with or immediately after eating a meal high in fat. It will be harder for the body to absorb this medication. If your symptoms don't improve within 7–10 days after using this medication, call your doctor. Keep the bottle tightly closed when not in use to avoid heat and moisture build-up.

Details on dosage

Usual Adult Dose for Insomnia:

Take 8 mg before bedtime.
Maximum Dose: 8 mg per day
Comments: Do not take this drug with or right after eating a meal high in fat.
Use: treatment for insomnia that is characterized by difficulty falling asleep.

What happens if I miss the dose?

You are unlikely to miss a dosage of Rozerem, as it is only taken at bedtime. Do not take this medication before you have slept for 7 to 8 consecutive hours. Take no more than one dose at any given time.

What happens if I overdose?

Call 1-800-222-1222 immediately if you suspect poison, or seek immediate medical advice.

What should be avoided?

Do not drink alcohol while taking this medication. Do not drive or engage in hazardous activities until you have determined how the medicine will affect you. You may be unable to react properly.

Side effects of Rozerem

Rozerem can cause severe allergic reactions. Seek emergency medical attention if you experience any of the following: hives, difficulty breathing, nausea, vomiting, or swelling of your lips, face, tongue, or throat. Some users of this medication have performed activities while not fully awake and then had no memory about them. This could include driving, walking, eating, having sexual relations, or even making a phone call. Call your doctor immediately if this happens.

If you experience:

  • Hallucinations or unusual behavior, depression worsening, thoughts of harming yourself
  • A missed menstrual period;
  • Nipple discharge;
  • Loss of interest in sexual activity

Some of the most common Rozerem side-effects include:

  • Drowsiness or tiredness
  • Dizziness;
  • Nausea;
  • Sleep problems can worsen.

There may be other side effects.Call your physician if experiencing side effects; for more information contact the FDA at 1-800-FDA-1088 and report adverse reactions.

Interaction with other drug

Not taking certain medicines together may not always be safe; certain drugs could interfere with each other and alter blood levels, potentially causing side effects or making them less effective. Informing your physician of all of the medicines you are currently taking or that have recently changed is also key for optimal health and wellbeing.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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