Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia.

Abstract

BACKGROUND AND PURPOSE:

To assess the efficacy and safety of ramelteon, a selective MT(1)/MT(2) receptor agonist, for chronic insomnia treatment.

PATIENTS AND METHODS:

Randomized, double-blind, placebo-controlled 35-night outpatient trial with weekly clinic visits at multiple centers. Patients include older adults (>or=65 years; N=829) with chronic insomnia. Placebo, ramelteon 4mg, or ramelteon 8mg were taken nightly for five weeks, and patient-reported sleep data were collected using sleep diaries. Primary efficacy was sleep latency at week 1. Sustained efficacy was examined at weeks 3 and 5. Rebound insomnia and withdrawal effects were evaluated during a 7-day placebo run-out.

RESULTS:

Both doses of ramelteon produced statistically significant reductions in sleep latency vs. placebo at week 1 (ramelteon 4mg: 70.2 vs. 78.5min, P=.008; ramelteon 8mg: 70.2 vs. 78.5 min, P=.008). Patients continued to report reduced sleep latency at week 3 with ramelteon 8mg (60.3 vs. 69.3min, P=.003), and at week 5 with ramelteon 4 mg (63.4 vs. 70.6 min, P=.028) and ramelteon 8 mg (57.7 vs. 70.6 min; P<.001). Statistically significant increases in total sleep time were observed with ramelteon 4 mg at week 1 (324.6 vs. 313.9 min, P=.004) and week 3 (336.0 vs. 324.3min, P=.007) compared with placebo. There was no evidence of significant rebound insomnia or withdrawal effects following treatment discontinuation. The incidence of adverse events was similar among all treatment groups; most were mild or moderate.

CONCLUSIONS:

In older adults with chronic insomnia, ramelteon significantly reduced patient reports of sleep latency over five weeks of treatment with no significant rebound insomnia or withdrawal effects.

• Authors: Thomas Roth, David Seiden, Stephen Sainati, Sherry Wang-Weigand, Jeffrey Zhang, Phyllis Zee
• Journal: Sleep medicine (Sleep Med) Vol. 7 Issue 4 Pg. 312-8 (Jun 2006) ISSN: 1389-9457 [Print] Netherlands
• PMID: 16709464 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hypnotics and Sedatives
• Indenes
• ramelteon

Topics

• Aged
• Aged, 80 and over
• Chronic Disease
• Double-Blind Method
• Drug Administration Schedule
• Electrocardiography
• Female
• Humans
• Hypnotics and Sedatives (adverse effects, pharmacology, therapeutic use)
• Indenes (adverse effects, pharmacology, therapeutic use)
• Male
• Middle Aged
• Sleep (drug effects)
• Sleep Initiation and Maintenance Disorders (drug therapy)
• Substance Withdrawal Syndrome (epidemiology, etiology)
• Surveys and Questionnaires
• Time Factors