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Ramelteon Shown Effective in a First-Night-Effect Model of Transient Insomnia With No Evidence of Next-Day Residual Effects

SALT LAKE CITY, UT -- June 20, 2006 -- Data presented at the SLEEP 2006 20th Anniversary Meeting of the Associated Professional Sleep Societies have shown that Rozerem(TM) (ramelteon) reduced time to fall asleep with no evidence of next-day residual effects, including psychomotor and memory effects, in a first-night-effect model of transient insomnia. The results of this double-blind, randomized study were presented as a poster presentation.

"Some medications taken for sleep are associated with lingering effects the next day, which could make performing activities requiring mental sharpness difficult or dangerous," said Gary Zammit, PhD, Director, Sleep Disorders Institute at St. Luke's-Roosevelt Hospital, New York. "These data suggest that Rozerem can promote sleep in patients with transient insomnia without evidence of next-day psychomotor or memory effects."

Study Design
A total of 289 healthy adults were randomized to receive either Rozerem 8 mg, 16 mg, or placebo 30 minutes before bedtime in this double-blind, parallel-group study designed to evaluate the efficacy of Rozerem in a first- night-effect model of transient insomnia.

Sleep was assessed with overnight polysomnography (PSG) -- a test that records brain activity and other body functions during sleep -- and a patient questionnaire completed the following morning. Patients also completed next-morning residual-effect assessments evaluating potential residual psychomotor or memory impairment.

Results found that Rozerem was not associated with next-morning residual effects, as measured by Digit Symbol Substitution Test, memory tests for immediate and delayed recall, and visual analog scales that rate patient reports of mood and feeling. Adverse event rates were 12.4 percent, 13.3 percent, and 6.4 percent for the placebo, Rozerem 8 mg, and Rozerem 16 mg groups, respectively, with no clinically meaningful changes in laboratory value, vital sign, or electrocardiogram results observed.

The study found that patients taking Rozerem 8 mg experienced a significant decrease in time to fall asleep compared to placebo, at 12.2 versus 19.7 minutes (P=0.004). Those taking Rozerem 16 mg also experienced a decrease in time to fall asleep, at 14.8 versus 19.7 minutes; however, the decrease was not statistically significant.

"The results of this trial add to the growing body of data from multiple clinical studies that show the treatment effects of Rozerem," said Louis Mini, MD, medical director, Neuroscience at Takeda in Lincolnshire, Ill. "These new data serve to further help physicians better understand this unique medication option and its potential benefits for their patients with insomnia."

About Rozerem
Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem can be prescribed for long-term use. Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence in clinical studies,* and as a result, has not been designated as a controlled substance.

With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the U.S. Drug Enforcement Administration. Rozerem has a unique therapeutic mechanism of action that selectively targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates 24-hour, or circadian rhythms, including the sleep-wake cycle.

* Rozerem is not a controlled substance. A clinical abuse liability study showed no differences indicative of abuse potential between Rozerem and placebo at doses up to 20 times the recommended dose (N=14). Three 35- day insomnia studies showed no evidence of rebound insomnia or withdrawal symptoms with Rozerem compared to placebo (N=2082).

Important Safety Information
Rozerem(TM) (ramelteon) should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with fluvoxamine. Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized underlying medical disorder. Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.

Rozerem has not been studied in patients with severe sleep apnea, severe COPD, or in children or adolescents. The effects in these populations are unknown. Avoid taking Rozerem with alcohol.

Rozerem has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. Rozerem should not be taken with or immediately after a high-fat meal. Rozerem should be taken within 30 minutes before going to bed and activities confined to preparing for bed.

The most common adverse events seen with Rozerem that had at least a 2% incidence difference from placebo were somnolence, dizziness, and fatigue.


SOURCE: Takeda Pharmaceuticals North America, Inc

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