Abstract | STUDY OBJECTIVES: DESIGN: Six-month, randomized, double-blind, placebo-controlled study. SETTING: Forty-six investigative sites in the United States, Europe, Russia, and Australia. PARTICIPANTS: Four hundred fifty-one adults (age > or = 18 years) with chronic primary insomnia. INTERVENTIONS:
Ramelteon, 8 mg, or placebo 30 minutes before bedtime nightly for 6 months. MEASUREMENTS: Sleep was evaluated by polysomnography and morning questionnaires on the first 2 nights of Week 1; the last 2 nights of Months 1, 3, 5, and 6; and Nights 1 and 2 of the placebo run-out. Next-morning residual effects as well as adverse effects and vital signs were recorded at each visit. Rebound insomnia and withdrawal effects were evaluated during placebo run-out. RESULTS: Over the 6 months of treatment, ramelteon consistently reduced latency to persistent sleep compared with baseline and with placebo; significant decreases were observed at Week 1 and Months 1, 3, 5, and 6 (P < 0.05). Ramelteon significantly reduced subjective sleep latency relative to placebo at Week 1, Month 1, and Month 5 (P < 0.05), with reductions nearing statistical significance at Months 3 and 6 (P < or = 0.08). No significant next-morning residual effects were detected during ramelteon treatment. No withdrawal symptoms or rebound insomnia were detected after ramelteon discontinuation. Most adverse events were mild or moderate in severity. CONCLUSIONS:
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Authors | Geert Mayer, Sherry Wang-Weigand, Barbara Roth-Schechter, Reiner Lehmann, Corinne Staner, Markku Partinen |
Journal | Sleep
(Sleep)
Vol. 32
Issue 3
Pg. 351-60
(Mar 2009)
ISSN: 0161-8105 [Print] United States |
PMID | 19294955
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Hypnotics and Sedatives
- Indenes
- ramelteon
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Topics |
- Adolescent
- Adult
- Aged
- Attention
(drug effects)
- Double-Blind Method
- Drug-Related Side Effects and Adverse Reactions
- Female
- Humans
- Hypnotics and Sedatives
(adverse effects, therapeutic use)
- Indenes
(adverse effects, therapeutic use)
- Male
- Memory, Short-Term
(drug effects)
- Middle Aged
- Polysomnography
(drug effects)
- Prospective Studies
- Retention, Psychology
(drug effects)
- Sleep Initiation and Maintenance Disorders
(drug therapy)
- Substance Withdrawal Syndrome
(diagnosis)
- Treatment Outcome
- Wakefulness
(drug effects)
- Young Adult
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