Conditions: Sleep Initiation and Maintenance Disorder; Elderly Mental Disorder Dyssomnias Sleep Disorders Sleep Disorder, Intrinsic
Keywords: elderly randomized double blind
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 259
Healthy volunteers: no

Brief summary:
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.

Detailed description:
Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.

The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on Total Sleep Time (TST) (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.

The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.

Arms:
arm 1: Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks arm 2: Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks

Interventions: intervention 1: Esmirtazapine
Intervention descriptions: intervention 1: One tablet daily

Protocol document: