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- Quiz: Suffer From Insomnia?
- What is Rozerem, and how does it work (mechanism of action)?
- What brand names are available for Rozerem?
- Is Rozerem available as a generic drug?
- Do I need a prescription for Rozerem?
- What are the side effects of Rozerem?
- What is the dosage for Rozerem?
- Which drugs or supplements interact with Rozerem?
- Is Rozerem safe to take if I'm pregnant or breastfeeding?
- What else should I know about Rozerem?
What is Rozerem, and how does it work (mechanism of action)?
Ramelteon is an oral drug that promotes falling asleep and is used for treating insomnia. It acts by stimulating receptors for melatonin in the brain. Melatonin and its receptors control the circadian rhythm of the body which controls the sleep/wake cycle. Unlike many drugs used for treating insomnia, ramelteon is not addictive, and it is not a controlled substance. Ramelteon also does not cause withdrawal symptoms or rebound insomnia when it is stopped. Ramelteon was approved by the FDA in July 1995.
What are the side effects of Rozerem?
Side effects associated with ramelteon include:
Rare cases of severe allergic reactions involving swelling of the tongue and closure of the throat have been reported.
Other important side effects include:
What is the dosage for Rozerem?
The recommended dose of ramelteon is 8 mg taken 30 minutes before bedtime. Ramelteon should not be taken with or immediately after a high fat meal because fat increases its absorption from the intestine.
Which drugs or supplements interact with Rozerem?
Doxepin (Sinequan, Adapin), donepezil (Aricept), fluvoxamine (Luvox, Luvox CR), ketoconazole (Nizoral, Extina, Xolegel, Kuric), and fluconazole (Sporanox) increase blood levels of ramelteon, possibly increasing side effects of ramelteon. Rifampin may decrease blood levels of ramelteon, possibly reducing the effect of ramelteon. Alcohol increases the sedative effects ramelteon.
Is Rozerem safe to take if I'm pregnant or breastfeeding?
Ramelteon has not been evaluated in pregnant women. Animal studies show that it may cause harm. Therefore, ramelteon should not be used in pregnant women unless it is absolutely necessary.
Ramelteon has not been evaluated in nursing mothers.
What else should I know about Rozerem?
What preparations of Rozerem are available?
How should I keep Rozerem stored?
Ramelteon should be store at room temperature, between 15 C - 30 C (59 F - 86 F).
Reference: FDA Prescribing Information
Ramelteon (Rozerem) is a medication prescribed for improving sleep in individuals who have insomnia that involves difficulty falling asleep. Side effects, drug interactions, warnings and precautions, and pregnancy safety should be reviewed prior to taking this medication.
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Top Rozerem Related ArticlesComplete List
Hypnotics Drug Class Side Effects
Hypnotics are sleep medications used to treat different types of insomnia. There are a variety of hypnotic drugs, and they are grouped into five types. Benzodiazepines, nonbenzodiazepines, selective melatonin agonists (these three drug types are classified as sedatives), antidepressants, and an orexin receptor agonist. Some hypnotics can be addictive and may cause withdrawal symptoms if discontinued abruptly.
The side effects of hypnotics depend upon the drug used, but they may include:
- Dry mouth
- Rebound insomnia
Other side effects may include:
- Hair loss
- Dry skin
- Upset stomach
- Abnormal dreams
Hypnotics may have serious side effects and adverse effects, for example:
- Abnormal thinking
- Suicidal thinking
- Sleep paralysis
- Sleep driving and other complex behavior
- Exfoliate dermatitis
Hypnotic drugs available over-the-counter (OTC) include diphenhydramine (Benadryl) and doxylamine (Unisom). Natural herbal supplements used for insomnia are melatonin and Valerian.
Do not drink alcohol while taking hypnotic drugs. Stimulants like caffeine or amphetamines reduce the effect of insomnia medications.
Your doctor or other health care professional will recommend the type of hypnotic drug for you depending upon the type of sleep problem you have, your current lifestyle habits, other medications you are taking, and any other medical problems you may have.
FDA. "Sleep Disorder (Sedative-Hypnotic) Drug Information." Updated: Jun 13, 2017.
Chawala, J, MD. "Insomnia Medication." Medscape. Updated: Aug 01, 2016.
InsomniaInsomnia is the perception or complaint of inadequate or poor-quality sleep because of difficulty falling asleep; waking up frequently during the night with difficulty returning to sleep; waking up too early in the morning; or unrefreshing sleep. Secondary insomnia is the most common type of insomnia. Treatment for insomnia include lifestyle changes, cognitive behavioral therapy, and medication.
A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about 7-9 hours of sleep each night for older, school-aged children, teens, and most average adults; 10-12 for preschool-aged children; and 16-18 hours for newborns. There are two stages of sleep; 1) REM sleep (rapid-eye movement), and 2) NREM sleep (non-rapid-eye movement). The side effects of lack of sleep or insomnia include:
- Feeling sleepy during the day
- Concentration or memory problems
Lack of sleep and insomnia can be caused by medical conditions or diseases, medications, stress, or pain. The treatment for lack of sleep and insomnia depends upon the cause.
Sleep Aids And StimulantsInsomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions, environmental changes and stressful events. Treatments may include non-drug treatments, over-the-counter medicines, and/or prescription medications.