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Basic Drug Info
Drug Name:ROZEREM
Manufacturer:Takeda Pharmaceuticals America, Inc.
Other Info:

Two controlled studies evaluated the effects of ROZEREM on endocrine function.In the first trial, ROZEREM 16 mg once daily or placebo was administered to 99 healthy volunteer subjects for 4 weeks.

This study evaluated the thyroid axis, adrenal axis and reproductive axis.

No clinically significant endocrinopathies were demonstrated in this study.

However, the study was limited in its ability to detect such abnormalities due to its limited duration.In the second trial, ROZEREM 16 mg once daily or placebo was administered to 122 subjects with chronic insomnia for 6 months.

This study evaluated the thyroid axis, adrenal axis and reproductive axis.

There were no significant abnormalities seen in either the thyroid or the adrenal axes.

Abnormalities were, however, noted within the reproductive axis.Overall, the mean serum prolactin level change from baseline was 4.9 µg/L (34% increase) for women in the ROZEREM group compared with -0.6 µg/L (4% decrease) for women in the placebo group (p=0.003).

No differences between active- and placebo-treated groups occurred among men.

Thirty-two percent of all patients who were treated with ramelteon in this study (women and men) had prolactin levels that increased from normal baseline levels compared to 19% of patients who were treated with placebo.

Subject-reported menstrual patterns were similar between the two treatment groups.In a 12-month, open-label study in adult and elderly patients, there were two patients who were noted to have abnormal morning cortisol levels, and subsequent abnormal ACTH stimulation tests.

A 29-year-old female patient was also diagnosed with a prolactinoma.

The relationship of these events to ROZEREM therapy is not clear.



Clinical Trials:


Indications and Usage
ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Sleeplessness -- Difficulty in going to sleep or getting enough sleep.

Contraindications
ROZEREM is contraindicated in patients with a hypersensitivity to ramelteon or any components of the ROZEREM formulation.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient.

The failure of insomnia to remit after a reasonable period of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, may be the result of an unrecognized underlying psychiatric or physical disorder and requires further evaluation of the patient.

As with other hypnotics, exacerbation of insomnia and emergence of cognitive and behavioral abnormalities were seen with ROZEREM during the clinical development program.ROZEREM should not be used by patients with severe hepatic impairment.ROZEREM should not be used in combination with fluvoxamine (see PRECAUTIONS: Drug Interactions).A variety of cognitive and behavior changes have been reported to occur in association with the use of hypnotics.

In primarily depressed patients, worsening of depression, including suicidal ideation, has been reported in association with the use of hypnotics.Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking ROZEREM.After taking ROZEREM, patients should confine their activities to those necessary to prepare for bed.

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