Paroxetine in the Treatment of Chronic Primary Insomnia

Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks

The goal of the study is to examine the role of paroxetine, an antidepressant medication, in the acute and continuation treatment of insomnia. Primary insomnia is a type of insomnia not directly resulting from general medical, chemical, or psychiatric conditions.

The primary aim of this study is to demonstrate the role of paroxetine in the acute treatment of chronic primary insomnia. Paroxetine taken on a nightly basis in combination with sleep hygiene therapy will produce a greater number of diagnostic responders in acute treatment, compared to a placebo and sleep hygiene control condition, in a randomized, double-blinded, six-week acute treatment trial. EEG sleep, sleep quality, and daytime well-being, and daytime functioning will also show superior treatment effects during acute treatment with paroxetine plus sleep hygiene, as compared with the placebo control condition. A total of 66 patients with primary insomnia, as defined by DSM-IV criteria, will be randomized (1:1) to receive paroxetine plus sleep hygiene therapy (P+SH-a) or placebo plus sleep hygiene therapy (PL+SH-a) in weekly acute treatment sessions evolving over a six-week interval in a double-blinded, parallel group design.

Paroxetine in combination with sleep hygiene therapy will produce a greater number of responders in acute treatment, compared to a placebo and sleep hygiene condition, in a randomized, double-blinded, six-week acute trial

Stress measures: Schedule of Recent Events, Perceived Stress Scale, Impact of Life Events Scale, Ways of Coping Inventory, Multidimensional Fatigue Inventory, and Brief Symptom Inventory

Psychophysiological arousal and mood measures collected at each sleep study: the Pres-Sleep Arousal Scale, Spielman Insomnia Symptom Questionnaire, Pittsburgh Insomnia Rating Scale, and the Pre-Sleep Experience Questionnaire.

Inclusion Criteria: Age 55 or older Diagnosis of chronic primary insomnia Score of 8 or higher on the Pittsburgh Sleep Quality Index free of all antidepressants and benzodiazepine for two weeks Exclusion Criteria: lifetime diagnosis of any psychotic disorder,or bipolar disorder. DSM-IV diagnosis of dysthymia or generalized anxiety disorder Diagnosis of major depression within the past 6 months Alcohol or drug abuse within the past 6 months Contraindication to SSRI therapy History of seizure disorder Baseline apnea/hypopnea index score greater than 15 Hyponatremia