NEWS HIGHLIGHTSMedia Articles Related to Rozerem (Ramelteon)
Stress, Bad Bedtime Habits Cause Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.07.27]
Title: Stress, Bad Bedtime Habits Cause Insomnia
Category: Health News
Created: 7/25/2009 7:00:00 AM
Last Editorial Review: 7/27/2009
Pills Plus Psychotherapy Can Beat Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.05.20]
Title: Pills Plus Psychotherapy Can Beat Insomnia
Category: Health News
Created: 5/20/2009 2:00:00 AM
Last Editorial Review: 5/20/2009
Insomnia
Source: MedicineNet Biorhythms Specialty [2009.03.03]
Title: Insomnia
Category: Diseases and Conditions
Created: 6/6/2005
Last Editorial Review: 3/3/2009
Insomnia Treatment: Sleep Aids and Stimulants
Source: MedicineNet Narcolepsy Specialty [2009.01.14]
Title: Insomnia Treatment: Sleep Aids and Stimulants
Category: Diseases and Conditions
Created: 9/24/1999 7:06:00 AM
Last Editorial Review: 1/14/2009
Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Source: MedicineNet temazepam Specialty [2008.06.05]
Title: Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Category: Doctor's Views
Created: 6/14/2005
Last Editorial Review: 6/5/2008
Published Studies Related to Rozerem (Ramelteon)
Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. [2009.05]
CONCLUSIONS: Ramelteon 8 mg, on average, reduced LPS by approximately 13 min more than placebo on nights 1 and 2 of treatment in adults with chronic insomnia. Ramelteon was well tolerated with a low incidence of adverse events. This mean reduction in LPS versus placebo is similar to what has been reported for other classes of insomnia medications. However, these results reflect nights 1 and 2 of treatment and may not be representative of longer treatments.
Safety and subjective sleep effects of ramelteon administration in adults and older adults with chronic primary insomnia: a 1-year, open-label study. [2009.04]
CONCLUSION: Year-long administration of ramelteon was well tolerated. Ramelteon was associated with sustained improvements in subjective sleep latency, subjective total sleep time, and Clinical Global Impressions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00671086. 2009 Physicians Postgraduate Press, Inc.
Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. [2009.03.01]
STUDY OBJECTIVES: Long-duration (> or = 6 months) polysomnographic studies of insomnia medications are lacking. This study evaluated the long-term efficacy of ramelteon, a selective MT1/MT2 melatonin-receptor agonist used for insomnia treatment... CONCLUSIONS: In adults with chronic insomnia, long-term ramelteon treatment consistently reduced sleep onset, with no next-morning residual effects or rebound insomnia or withdrawal symptoms upon discontinuation.
Ramelteon for the treatment of insomnia in menopausal women. [2009.03]
OBJECTIVE: Sleep disturbances have been reported to be one of the most troubling manifestations of menopause. While hormone replacement therapy (HRT) has historically been considered a first-line treatment for menopausal insomnia, many women are now seeking alternative treatments due to concerns about the risks and side-effects of HRT. The goal of this study was to evaluate the effect of ramelteon, a selective melatonin receptor agonist, for the treatment of menopausal insomnia... CONCLUSIONS: Overall, results suggest that ramelteon is an effective non-hormonal approach for the treatment of insomnia in menopause. Randomized-controlled trials are needed to further evaluate the efficacy of this intervention.
Effects of long-term exposure to ramelteon, a melatonin receptor agonist, on endocrine function in adults with chronic insomnia. [2009.03]
OBJECTIVE: To evaluate the effects of ramelteon, an MT(1)/MT(2) melatonin receptor agonist used to treat insomnia, on endocrine function in adults with chronic insomnia... CONCLUSIONS: Long-term exposure to ramelteon 16 mg, a potent melatonin receptor agonist, resulted in mild, transient increase in prolactin, in women only, that were not associated with measurable reproductive effects. There were no consistent changes in other endocrine measures.
Clinical Trials Related to Rozerem (Ramelteon)
A Study to Evaluate the Ability of Ramelteon to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag in Healthy Adult Volunteers [Completed]
This is a study to evaluate the ability of ramelteon to alleviate the insomnia symptoms of
eastbound jet lag in healthy adult volunteers. Subjects are screened in Hawaii, and then
travel to the Eastern Time Zone for randomization to receive either ramelteon or a placebo
during evaluation in a sleep laboratory.
A Study to Evaluate the Phase-Shifting Effects of Repeated Daily Dosing of TAK-375 in Healthy Subjects [Completed]
This was a Dose-Ranging Study to Evaluate TAK-375 at 1 mg, 2 mg, 4 mg, or 8 mg versus a
placebo taken once daily for five days.
Treatment of Subjects With Mild to Moderate Alzheimer's Disease and Sleep Treatment of Subjects Who Have Mild to Moderate Alzheimer's Disease and Sleep Disturbance With Rozerem™ [Completed]
The purpose of the study is to determine if subjects with mild to moderate Alzheimer's
Disease and sleep disturbance will benefit from treatment with Rozerem.
A Safety and Efficacy Study of TAK-375 in Adults With Chronic Insomnia [Completed]
This was a study to evaluate the efficacy and safety of 8 mg TAK-375, 16 mg of TAK-375 or a
placebo taken once daily in adults with chronic insomina for 7 weeks.
A Safety and Efficacy Outpatient Study of TAK-375 in Adults With Chronic Insomnia [Completed]
This was a study to evaluate the efficacy and safety of 8 mg TAK-375, 16 mg of TAK-375 or a
placebo taken once daily in adults with chronic insomnia.
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