Brand Name : Rozerem
Generic Name : Ramelteon
Treatment for : Insomnia
FDA Approved :- The U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA).
Rozerem is specifically indicated for the treatment of insomnia characterized by difficulty in falling asleep. Unlike many other hypnotic agents, clinical and animal trials of Rozerem did not yield evidence of formation of physical dependence or abuse potential, and the drug is not a controlled substance.
Rozerem Uses :- Rozerem is a prescription medicine for adults to treat insomnia where the problem is trouble falling asleep. Rozerem has not been studied in children. It is not known if Rozerem is safe and effective for children.
Insomnia is threat to health :- Insomnia has been linked to a variety of health problems, including obesity, diabetes, hypertension, heart disease and depression. According to the U.S. Surgeon General, nearly $15 billion annually is spent on healthcare related to insomnia, while $50 billion is lost in productivity.
Do Not Take Rozerem :- You should not take Rozerem if you have any of the following conditions: - are allergic to ramelteon or any of its ingredients
- have severe liver disease
Side Effects of Rozerem :- The following are the major potential risks and side effects of Rozerem therapy. However, this list is not complete. The following are the major potential risks and side effects of Rozerem therapy:
Worsening of insomnia, mental, or behavior changes. These may happen if your insomnia is caused by a mental or medical problem. Your healthcare professional should check you carefully for other health problems before prescribing Rozerem. Tell your healthcare professional if you develop: - worse insomnia
- mental problems including thoughts of harming yourself
- behavior changes
Drowsiness. Rozerem may affect your ability to drive or do other dangerous activities. Do not do these activities after taking Rozerem. After taking Rozerem, do only activities needed to get ready for bed. Affect reproductive hormones. 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. Your healthcare professional may do blood tests to check your hormone levels if you have any of these symptoms. Some common side effects that may occur with Rozerem include: headache, daytime sleepiness, dizziness, tiredness, nausea, worsening insomnia, colds
Tell your healthcare professional :- Before you start taking Rozerem if you:,
- have or had liver disease
- have breathing problems when you sleep (severe sleep apnea) or a lung disease called severe chronic obstructive pulmonary disease (COPD). Rozerem is not recommended if you have these problems.
- are trying to become pregnant, already pregnant, or are breastfeeding
Rozerem Precautions :- Rozerem and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Rozerem works or Rozerem may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional.
Rozerem Indication :- Tell your healthcare professional if you take:- fluvoxamine, rifampin (Rifadin), ketoconazole (Nizoral), fluconazole (Diflucan). Tell your healthcare provider if you drink alcohol. Alcohol may increase the side effects with Rozerem.
Rozerem Dose :- Take Rozerem by mouth within 30 minutes of going to bed. Do not take Rozerem with or right after a high fat meal. |
Types of insomnia and their consequences :-
| Transient Insomnia |
Intermittent Insomnia |
Chronic Insomnia |
|
Insomnia can be described as short-term, or transient, and typically lasts from a few nights to a few weeks. Transient insomnia may cause next-day sleepiness, changes in mood, and psychomotor performance impairment. |
Having periods of transient insomnia that occur on and off is considered intermittent insomnia. Intermittent insomnia can lead to chronic insomnia. |
Long-term, or chronic, insomnia occurs when an individual has difficulty sleeping that persists for more than a month. Chronic insomnia is often related to more serious manifestations including depression, memory impairment, accidents, absenteeism, and increased healthcare utilization. |
Factors contribute to insomnia :-
| Predisposing factors |
Precipitating factors |
Perpetuating factors |
may be present in a person long before symptoms appear. These factors include physiological hyperarousal, cognitive arousal, emotional arousal, and decreased homeostatic sleep drive. |
increase the propensity for insomnia over a threshold, causing insomnia to appear. Medical or psychiatric illness, drug use, shift work, stressful life events, and sleep disorders like sleep apnea are all types of precipitating factors. |
are those that exacerbate insomnia. These factors can prolong the insomnia even after the initial cause is eliminated. Perpetuating factors include a sedentary
lifestyle, poor sleep hygiene, and excessive worry about sleeping.
| |
