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Rozerem ® (Ramelteon) is a new development in sleep therapy. It is a prescription medicine, but a non-controlled, sleeping aid for adults to treat insomnia, a problem characterized by difficulty with onset of sleep.

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Rozerem ®
  Product Ships Rx Price Order
Rozerem 8MG 30 Tablets USA Free $149
Rozerem 8MG 60 Tablets USA Free $259
Rozerem 8MG 90 Tablets USA Free $369



Rozerem ® is manufactured by Takeda Pharmaceuticals North America, Inc.

Chemical Name : Ramelteon

Important Note
The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

Uses

Insomnia is not merely the inability to sleep at night; it is when an individual experiences daytime consequences as a result of a difficulty in initiating or maintaining sleep or having sleep that is not refreshing. And the severity of these consequences is directly related to the type of insomnia the individual is experiencing which is classified as Transient, Intermittent and Chronic Insomnia. Recent research suggests that several bouts of transient insomnia can lead to chronic insomnia, and one of the current treatment goals is to prevent this evolution.

Rozerem (ramelteon) acts on two melatonin receptors in the brain, as opposed to the conventional targeting of the GABA-A receptor. Resultantly, it has lesser side effects than other sleeping pills and is indicated for long-term use.

How to take this medication
Rozerem is not a controlled substance. The recommended dose of Rozerem is 8mg take within 30 minutes before going to bed and activities should be confined to those necessary to prepare for bed. Intake of this medicine should not be with or immediately after a high-fat meal.

Side Effects
Side effects, which may go away during treatment, include headache, daytime sleepiness, dizziness, tiredness, nausea, worsening insomnia, colds. If they continue or are bothersome, check with your doctor.

Rozerem may affect the reproductive hormones by increasing prolactin and potentially decreasing testosterone levels. This may cause missed monthly periods, nipple drainage, decreased sex drive, or problems getting pregnant.

Precautions
Rozerem should not be used by patients with severe hepatic impairment, or in patients in combination with fluvoxamine. It has not been studied in subjects with severe sleep apnea or severe COPD and is not recommended for use in those populations. Rozerem has been associated with decreased testosterone levels and increased prolactin levels. Its effect has not been studied in children or adolescents, and the effects in these populations are unknown.

Engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem should be avoided.

No clinical studies in nursing mothers have been performed and consequently the use of Rozerem in nursing mothers is not recommended.

Drug Interactions
Rozerem and certain other medicines can interact with each other. Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine, you consume alcohol or if you smoke. Alcohol may increase the side effects with Rozerem.

Some medicines may affect how Rozerem works or it may affect how your other medicines work. Especially if you take: fluvoxamine, rifampin (Rifadin), ketoconazole (Nizoral) or fluconazole (Diflucan).

Missed Dose
Try to take each dose at the scheduled time. If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. There should be an interval of at least 4 to 6 hours between doses.

Storage
Store this medication at room temperature between 59 and 77 degrees F (15 to 25 degrees C) away from heat and light. Keep this and all medications out of the reach of children.

 
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   Treatment of Insomnia : Treatment of Transient and Intermittent Insomnia may not require treatment since, by definition, the episodes of insomnia only last a few days at a time. For example, if insomnia is due to a temporary change in the sleep/wake schedule, as with jet lag, the person's biological clock will often get back to normal on its own. However, for some people who experience daytime sleepiness and impaired performance as a result of transient insomnia, the use of short-acting sleeping pills may improve sleep and next-day alertness. As with all drugs, there are potential side effects. The use of over-the-counter sleep medicines is not usually recommended for the treatment of insomnia. Treatment of Chronic Insomnia consists of : First, diagnosing and treating underlying medical or psychological problems. Identifying behaviors that may worsen insomnia and stopping (or reducing) them. Possibly using sleeping pills, although the long-term use of sleeping pills for chronic insomnia is controversial. A patient taking any sleeping pill should be under the supervision of a physician to closely evaluate effectiveness and minimize side effects. In general, these drugs are prescribed at the lowest dose and for the shortest duration needed to relieve the sleep-related symptoms. For some of these medicines, the dose must be gradually lowered as the medicine is discontinued because, if stopped abruptly, it can cause insomnia to occur again for a night or two. Trying behavioral techniques to improve sleep, such as relaxation therapy, sleep restriction therapy, and reconditioning. Relaxation Therapy: There are specific and effective techniques that can reduce or eliminate anxiety and body tension. As a result, the person's mind is able to stop "racing," the muscles can relax, and restful sleep can occur. It usually takes much practice to learn these techniques and to achieve effective relaxation. Sleep Restriction: Some people suffering from insomnia spend too much time in bed unsuccessfully trying to sleep. They may benefit from a sleep restriction program that at first allows only a few hours of sleep during the night. Gradually the time is increased until a more normal night's sleep is achieved. Reconditioning: Another treatment that may help some people with insomnia is to recondition them to associate the bed and bedtime with sleep. For most people, this means not using their beds for any activities other than sleep and sex. As part of the reconditioning process, the person is usually advised to go to bed only when sleepy. If unable to fall asleep, the person is told to get up, stay up until sleepy, and then return to bed. Throughout this process, the person should avoid naps and wake up and go to bed at the same time each day. Eventually the person's body will be conditioned to associate the bed and bedtime with sleep.

Chronic Insomnia : Insomnia that occurs most nights and lasts a month or more. The treatment of chronic insomnia consists of: First, the diagnosis and treatment of underlying medical or psychological problems. The identification of behaviors that may worsen insomnia and stopping (or reducing) them. A possible trial of sleeping pills, although the long-term use of sleeping pills for chronic insomnia is controversial. A patient taking any sleeping pill should be under the supervision of a physician to closely evaluate effectiveness and minimize side effects. In general, these drugs are prescribed at the lowest dose and for the shortest duration needed to relieve the sleep-related symptoms. For some of these medicines, the dose must be gradually lowered as the medicine is discontinued because, if stopped abruptly, it can cause insomnia to occur again for a night or two. A trial of behavioral techniques to improve sleep, such as relaxation therapy, sleep restriction therapy, and reconditioning. There are specific and effective techniques that can reduce or eliminate anxiety and body tension. As a result, the person's mind is able to stop "racing," the muscles can relax, and restful sleep can occur. It usually takes much practice to learn these techniques and to achieve effective relaxation. Some people suffering from insomnia spend too much time in bed unsuccessfully trying to sleep. They may benefit from a sleep restriction program that at first allows only a few hours of sleep during the night. Gradually the time is increased until a more normal night's sleep is achieved. Another treatment that may help some people with insomnia is to recondition them to associate the bed and bedtime with sleep. For most people, this means not using their beds for any activities other than sleep and sex. As part of the reconditioning process, the person is usually advised to go to bed only when sleepy. If unable to fall asleep, the person is told to get up, stay up until sleepy, and then return to bed. Throughout this process, the person should avoid naps and wake up and go to bed at the same time each day. Eventually the person's body will be conditioned to associate the bed and bedtime with sleep.

Types of Insomnia: Insomnia can be classified as transient (short term), intermittent (on and off), and chronic (constant). Insomnia lasting from a single night to a few weeks is referred to as transient. If episodes of transient insomnia occur from time to time, the insomnia is said to be intermittent. Insomnia is considered to be chronic if it occurs on most nights and lasts a month or more. Causes of Insomnia: Certain conditions seem to make individuals more likely to experience insomnia. Examples of these conditions include: advanced age (insomnia occurs more frequently in those over age 60); female gender; and a history of depression. If other conditions (such as stress, anxiety, a medical problem, or the use of certain medications) occur along with the above conditions, insomnia is more likely. There are many causes of insomnia. Transient and intermittent insomnia generally occur in people who are temporarily experiencing one or more of the following: stress, environmental noise, extreme temperatures, a change in the surrounding environment, sleep/wake schedule problems such as those due to jet lag, or medication side effects. Chronic insomnia is more complex and often results from a combination of factors, including underlying physical or mental disorders. One of the most common causes of chronic insomnia is depression. Certain Behaviors: Behaviors that perpetuate insomnia in some people include: expecting to have difficulty sleeping and worrying about it, ingesting excessive amounts of caffeine, drinking alcohol or smoking cigarettes before bedtime, excessive napping in the afternoon or evening, and irregular or continually disrupted sleep/wake schedules. These behaviors may prolong existing insomnia, and they can also be responsible for causing the sleeping problem in the first place. Stopping these behaviors may eliminate the insomnia altogether. Who Has Insomnia? Insomnia is found in males and females of all age groups, although it seems to be more common in females (especially after menopause) and in the elderly. The ability to sleep, rather than the need for sleep, appears to decrease with advancing age.

Insomnia: The perception or complaint of inadequate or poor-quality sleep because of one or more of the following: difficulty falling asleep; waking up frequently during the night with difficulty returning to sleep; waking up too early in the morning; or unrefreshing sleep. Insomnia is not defined by the number of hours of sleep a person gets or how long it takes to fall asleep. Individuals vary normally in their need for, and their satisfaction with, sleep. Insomnia may cause problems during the day, such as tiredness, a lack of energy, difficulty concentrating, and irritability.
 

 

 

 

 

 

14th March 2010