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Ramelteon Showed Significant Reduction in Time to Fall Asleep With No Evidence of Rebound Insomnia or Withdrawal Effects

SAN DIEGO, C.A. -- April 10, 2006 -- Results of a sub-analysis from a phase 3 clinical study showed that Rozerem™ (ramelteon) significantly reduced time to fall asleep in adults with chronic insomnia and showed no evidence of rebound insomnia or withdrawal effects.

The results were presented today at the 2006 Annual Meeting of the American Academy of Neurology (AAN).

In this placebo-controlled analysis, approximately two-thirds of patients who received 8 mg of Rozerem experienced at least a 50% reduction in the time it took them to fall asleep. Study participants also experienced no rebound insomnia or withdrawal effects following discontinuation of treatment with Rozerem. Rebound insomnia is the worsening of insomnia symptoms after a person stops taking their insomnia medications.

"These data show that Rozerem can be effective in helping patients fall asleep faster without rebound insomnia and other withdrawal effects," said Thomas Roth, PhD, director of the Sleep Disorders and Research Center, Detroit, Mich. "This may represent another option for patients who are looking for a sleeping medication that is right for them."

About the Study
In this sub-analysis of a large, double-blind, placebo-controlled study, a total of 269 adults received 8 mg of Rozerem (n=138) or placebo (n=131) nightly for five weeks (35 nights). Sleep parameters were evaluated at weeks 1, 3, and 5 by using a polysomnograph. Rozerem was replaced with placebo for the two nights following the study (nights 36 and 37) to evaluate rebound insomnia and withdrawal effects.

The primary endpoint was the percentage of patients who achieved at least 50% improvement in the time it took to fall asleep (latency to persistent sleep, or LPS).

Results showed that a statistically significantly greater percentage of adults with chronic insomnia treated with Rozerem 8 mg demonstrated at least 50% LPS reduction compared to those who received placebo at week 1 (63% vs. 40% (P <.001)).

Those results were sustained throughout the study (63% vs. 41% at week 3 (P <.001); 66% vs. 48% at week 5 (P <.005)).

The analysis revealed no evidence of rebound insomnia or withdrawal for patients taking Rozerem as measured by the BWSQ. Adverse events were similar in both groups, with somnolence, fatigue and headache being the only events reported in 5% or more of patients in either group. This incidence was similar to that seen in other clinical studies.

"It is estimated that about 60 million people in the U.S. struggle with symptoms of insomnia, and this is even more significant as we learn more about the relationship between sleep disorders and other medical conditions, and the consequences of poor sleep. In this analysis of chronic insomnia patients, it was shown that approximately two-thirds had their sleep onset time cut in half – or better – with the use of Rozerem 8 mg. This effect continued through all five weeks of the study," said Louis Mini, MD, medical director, Neuroscience at Takeda Pharmaceuticals North America, Lincolnshire, Ill. "These results represent another measure of the effectiveness of Rozerem, and can help patients and physicians better understand this unique option for the treatment of insomnia."

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.

The FDA approved Rozerem in July 2005 for the treatment of insomnia, characterized by difficulty with sleep onset. It is approved for long-term use in adults.

*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 is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem can be prescribed for long-term use. Rozerem 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. Exercise caution if consuming alcohol in combination with Rozerem.

· 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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