New ramelteon data presented at AARC

Results of this double-blind, placebo-controlled trial were presented at the 53rd International Respiratory Congress of the American Association for Respiratory Care.

“Getting adequate sleep is essential to maintaining health in people who live with COPD. These results suggest that ramelteon is a sleep medication that can be used safely in adults suffering from moderate to severe COPD who are concerned with breathing impairment during sleep,” said Thomas Roth, PhD, director, Henry Ford Sleep Research and Disorders Center. “While traditional sleep aids can negatively affect respiration during sleep in patients with COPD, this study demonstrated that ramelteon does not produce such respiratory depressant effects.”

According to the National Institutes of Health, more than 12 million Americans are currently diagnosed with COPD. It is the fourth leading cause of death in the United States and causes serious, long-term disability.

“Patients with COPD – usually characterized by a combination of chronic bronchitis and emphysema – must take extreme care in ensuring they receive enough oxygen at all times, particularly when sleeping. Other medications used for insomnia may reduce upper airway muscle tone, which can lead to increased hypoxemia,” said Dr. Roth. “This study shows that there was no difference in blood oxygen saturation all night between placebo and ramelteon.”

Study Design

A total of 25 adults age 40 or older with moderate to severe COPD were randomized to receive ramelteon 8 mg or placebo 30 minutes before overnight monitoring of oxygen saturation (SaO2) by pulse oximetry and sleep by polysomnography. After a five- to ten-day washout, patients crossed over to the alternate treatment and repeated the procedure.

The primary endpoint was mean SaO2 for the entire night. The findings revealed that there was no statistically significant difference in SaO2 for the entire night observed among the patients treated with ramelteon compared to placebo (92.2 vs. 92.4%, P=0.576). Additional results showed:

Compared with placebo, there was no statistically significant difference in the number of minutes in the night that SaO2 was <80% and <90% (P=0.927 and P=0.653, respectively).

The mean apnea-hypopnea index was similar between ramelteon and placebo (P=0.804).

A significant increase in total sleep time (389.0 vs 348.4 min, P=0.019) and sleep efficiency (81.0 vs 72.6%, P=0.019) was observed with ramelteon vs placebo.

Latency to persistent sleep was shorter with ramelteon vs placebo (23.1 vs 56.9 min) (P=0.051).

Adverse events were reported in four patients with ramelteon and four patients with placebo treatment; none was noted as serious or led to study discontinuation.

People with COPD have few options for treating insomnia because the traditional sleep medications cause a sedative effect that can further depress respiration. “This study is important in helping us understand the effects of ramelteon in patients with moderate to severe COPD,” said Louis J. Mini, MD, medical director, Neuroscience, Takeda Pharmaceuticals North America, Inc. “COPD is a common disorder seen in clinical practice, and studies of this type provide useful information for physicians treating this population.” -Ketchum