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Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia.
Sleep Med 2006; 7(4):312-8SM

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+Show Affiliations

Sleep Disorders and Research Center, Henry Ford Hospital, 2799 West Grand Boulevard, CFP-3, Detroit, MI 48202, USA. troth1@hfhs.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16709464

Citation

Roth, Thomas, et al. "Effects of Ramelteon On Patient-reported Sleep Latency in Older Adults With Chronic Insomnia." Sleep Medicine, vol. 7, no. 4, 2006, pp. 312-8.
Roth T, Seiden D, Sainati S, et al. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006;7(4):312-8.
Roth, T., Seiden, D., Sainati, S., Wang-Weigand, S., Zhang, J., & Zee, P. (2006). Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Medicine, 7(4), pp. 312-8.
Roth T, et al. Effects of Ramelteon On Patient-reported Sleep Latency in Older Adults With Chronic Insomnia. Sleep Med. 2006;7(4):312-8. PubMed PMID: 16709464.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. AU - Roth,Thomas, AU - Seiden,David, AU - Sainati,Stephen, AU - Wang-Weigand,Sherry, AU - Zhang,Jeffrey, AU - Zee,Phyllis, Y1 - 2006/05/18/ PY - 2005/10/07/received PY - 2006/01/03/revised PY - 2006/01/04/accepted PY - 2006/5/20/pubmed PY - 2006/11/11/medline PY - 2006/5/20/entrez SP - 312 EP - 8 JF - Sleep medicine JO - Sleep Med. VL - 7 IS - 4 N2 - 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. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/16709464/Effects_of_ramelteon_on_patient_reported_sleep_latency_in_older_adults_with_chronic_insomnia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(06)00010-4 DB - PRIME DP - Unbound Medicine ER -