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Efficacy and tolerability of indiplon in older adults with primary insomnia.
Sleep Med 2007; 8(7-8):753-9SM

Abstract

OBJECTIVE

To evaluate the efficacy and safety of indiplon in elderly patients with primary insomnia.

PATIENTS AND METHODS

Elderly patients, 65-80 years (N=358; 55% female; mean age, 71 years) who met the criteria for primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) for three months were randomized to two weeks of double-blind nightly treatment with 5 mg or 10 mg indiplon or placebo. Daily self-assessments by the patients included latency to sleep onset (LSO), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and sleep quality. Data were collected between July, 2002, and October, 2003, at 52 clinical research sites in North America.

RESULTS

Treatment with indiplon was associated with significant reduction in LSO at Week 1 for the 5 mg (34.6+/-1.8 min) and 10 mg doses (30.4+/-1.6 min) relative to placebo (47.4+/-2.5 min; p<0.0001 for both comparisons). During Week 2, LSO remained shorter on both indiplon doses compared to placebo (5 mg, p=0.016; and 10 mg, p=0.0028). During both study weeks, treatment with indiplon was also associated with significant improvement, relative to placebo, in TST, NAW, WASO, and sleep quality. The frequency of adverse events was similar in the indiplon 5 mg and placebo groups; somnolence, nausea, depression and decreased appetite were slightly more common in the indiplon 10 mg group.

CONCLUSION

In elderly patients with primary insomnia, indiplon 5 mg and 10 mg were efficacious in inducing and maintaining sleep and improving sleep quality during the two weeks of treatment. Indiplon 5mg was well-tolerated, with no serious adverse events and no significant changes in electrocardiogram (ECG) or routine clinical laboratory evaluations; the 10mg dose produced slightly greater efficacy as well as somewhat increased adverse events.

Authors+Show Affiliations

Sleep Medicine and Research Center, St. John's/St. Luke's Hospitals, 232 S. Woods Mill Road, Chesterfield, St. Louis, MO 63017, USA. jwalsh@stlo.smhs.comNo 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

17825616

Citation

Walsh, James K., et al. "Efficacy and Tolerability of Indiplon in Older Adults With Primary Insomnia." Sleep Medicine, vol. 8, no. 7-8, 2007, pp. 753-9.
Walsh JK, Moscovitch A, Burke J, et al. Efficacy and tolerability of indiplon in older adults with primary insomnia. Sleep Med. 2007;8(7-8):753-9.
Walsh, J. K., Moscovitch, A., Burke, J., Farber, R., & Roth, T. (2007). Efficacy and tolerability of indiplon in older adults with primary insomnia. Sleep Medicine, 8(7-8), pp. 753-9.
Walsh JK, et al. Efficacy and Tolerability of Indiplon in Older Adults With Primary Insomnia. Sleep Med. 2007;8(7-8):753-9. PubMed PMID: 17825616.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of indiplon in older adults with primary insomnia. AU - Walsh,James K, AU - Moscovitch,Adam, AU - Burke,Joshua, AU - Farber,Robert, AU - Roth,Thomas, Y1 - 2007/09/06/ PY - 2006/09/04/received PY - 2006/12/04/revised PY - 2006/12/04/accepted PY - 2007/9/11/pubmed PY - 2008/2/5/medline PY - 2007/9/11/entrez SP - 753 EP - 9 JF - Sleep medicine JO - Sleep Med. VL - 8 IS - 7-8 N2 - OBJECTIVE: To evaluate the efficacy and safety of indiplon in elderly patients with primary insomnia. PATIENTS AND METHODS: Elderly patients, 65-80 years (N=358; 55% female; mean age, 71 years) who met the criteria for primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) for three months were randomized to two weeks of double-blind nightly treatment with 5 mg or 10 mg indiplon or placebo. Daily self-assessments by the patients included latency to sleep onset (LSO), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and sleep quality. Data were collected between July, 2002, and October, 2003, at 52 clinical research sites in North America. RESULTS: Treatment with indiplon was associated with significant reduction in LSO at Week 1 for the 5 mg (34.6+/-1.8 min) and 10 mg doses (30.4+/-1.6 min) relative to placebo (47.4+/-2.5 min; p<0.0001 for both comparisons). During Week 2, LSO remained shorter on both indiplon doses compared to placebo (5 mg, p=0.016; and 10 mg, p=0.0028). During both study weeks, treatment with indiplon was also associated with significant improvement, relative to placebo, in TST, NAW, WASO, and sleep quality. The frequency of adverse events was similar in the indiplon 5 mg and placebo groups; somnolence, nausea, depression and decreased appetite were slightly more common in the indiplon 10 mg group. CONCLUSION: In elderly patients with primary insomnia, indiplon 5 mg and 10 mg were efficacious in inducing and maintaining sleep and improving sleep quality during the two weeks of treatment. Indiplon 5mg was well-tolerated, with no serious adverse events and no significant changes in electrocardiogram (ECG) or routine clinical laboratory evaluations; the 10mg dose produced slightly greater efficacy as well as somewhat increased adverse events. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/17825616/Efficacy_and_tolerability_of_indiplon_in_older_adults_with_primary_insomnia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(06)00712-X DB - PRIME DP - Unbound Medicine ER -