Ramelteon - a new medication for insomnia

Ramelteon is actually a truly different type of sleep medication. It works by mimicing melatonin, a naturally occuring hormone that is produced during the sleep period. Scientifically, it’s called a selective ML-1 receptor agonist. Tests show that treatment with ramelteon significantly shortened latency to sleep onset and somewhat increased total duration of sleep. Side effects seem to be minor, with headaches being the most common complaint.

Will it prove as effective as other sleep medications such as Ambien and Lunesta? That's the question, and the jury is still out. Most likely, it will be another tool in the doctor's arsenal. It will work for some patients, but not for others. The fact that it has low side effects and doesn't seem to cause dependence (based on tests with monkeys) means it will be appealing to some. And many people don't need much help to sleep, only a little. Ramelteon, even if it is weaker, could still be valuable.

Recent study on ramelteon for insomnia.

The Japanese corporation Takeda makes Ramelteon.

PDFs:

Drug profile from ADIS International Limited

Ramelteon: A Viewpoint by Goran Hajak

Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist.

An efficacy, safety, and dose–response study of Ramelteon in patients with chronic primary insomnia

Melatonin and sleep in aging population.

Older adults with insomnia report falling asleep faster with ramelteon - May 13, 2005

Results from a Phase 3 clinical study presented at the 2005 Annual Scientific Meeting of the American Geriatrics Society showed that bedtime administration of ramelteon, an investigational compound currently under review for the treatment of insomnia, significantly reduced time to fall asleep in older adults with chronic insomnia. Additionally, no rebound insomnia or withdrawal effects were observed.

A total of 829 older adults (ages 64–93 years) were enrolled in a randomized, double-blind, 5-week study. Participants received bedtime administration of one of three treatments: ramelteon 4 or 8 mg, or placebo. Study participants completed next-morning sleep questionnaires regarding their previous night's sleep for each night during the study.

Analysis of data from the questionnaires showed that, in comparison to those who received placebo, study participants who received ramelteon 4 or 8 mg had statistically significant decreases in estimates of time to fall asleep. In addition, after patients discontinued the use of ramelteon, there was no rebound insomnia, nor did patients exhibit symptoms of withdrawal. The incidence of adverse events for both ramelteon 4 mg and 8 mg dose groups was comparable with that of placebo.

Takeda submits New Drug Application for ramelteon.

From Sept 30, 2004 press release from Takeda Global Research & Development Center.

Takeda has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) to market ramelteon (TAK-375), its investigational drug for insomnia. Ramelteon belongs to a new class of prescription drugs with the first novel mechanism of action to be developed in 35 years in the area of sleep research. Ramelteon specifically targets the MT1 and MT2 receptors in the brain, which are believed to be critical in the regulation of the body's sleep-wake cycle. The submission is based on data collected from Takeda's extensive clinical research programme, including recently completed Phase III studies. The clinical research programme included more than 4200 patients, aged 18 to 93 years, who received single daily doses of ramelteon for various periods of time up to one year. Ramelteon has been studied in clinical trials in the US, Japan and Europe. Seven placebo-controlled trials were conducted to determine the efficacy of ramelteon in the treatment of insomnia, and results from 42 ramelteon trials are summarised in the company's safety database. The company's clinical research database also includes interim data from an ongoing, year-long safety study. In addition, Takeda has conducted animal and human studies to further assess ramelteon's safety attributes. These studies specifically evaluate whether or not treatment with ramelteon has the risk of drug dependence and abuse associated with other FDA-approved drugs for insomnia.

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"Sleep hath seized me wholly"

(William Shakespeare – Cymebline)