eszopiclone and Anxiety-Disorders

Generalized anxiety disorder (GAD) has a lifetime prevalence in the US population of about 5.7%. Typically, GAD begins in early adulthood and tends to have a chronic and persistent course. The disorder frequently presents comorbidly with other conditions, and about 90% of patients with GAD have at least 1 comorbid lifetime psychiatric disorder. Patients with GAD tend to be high users of medical services; the disorder is associated with significant physical as well as psychological symptomatology and impacts health, family relationships, and employment. Pharmacologic and psychosocial treatments are available for GAD. Different side effect profiles, speed of onset of action, and discontinuation requirements of individual drugs need to be taken into account when selecting treatment. Treatment selection should include consideration of comorbidity, psychological function, social impairment, and refractoriness, as well as the need for ongoing intervention for many individuals. Innovative treatments, including anticonvulsants, atypical antipsychotics, and others, as well as treatment targeting concomitant insomnia, may help improve outcomes for affected individuals.

Topics: Anti-Anxiety Agents; Anticonvulsants; Antidepressive Agents, Tricyclic; Antipsychotic Agents; Anxiety Disorders; Azabicyclo Compounds; Benzodiazepines; Buspirone; Chronic Disease; Citalopram; Cognitive Behavioral Therapy; Comorbidity; Diagnosis, Differential; Drug Therapy, Combination; Eszopiclone; Humans; Mental Health Services; Neurobiology; Neuroprotective Agents; Piperazines; Prevalence; Recurrence; Riluzole; Selective Serotonin Reuptake Inhibitors; United States

Insomnia and generalized anxiety disorder (GAD) are prevalent disorders that may coexist.. To determine the efficacy of eszopiclone combined with escitalopram oxalate in treating insomnia comorbid with GAD.. Double-blind, randomized, placebo-controlled, parallel-group, add-on therapy 10-week study.. Multicenter outpatient study from July 2005 to April 2006.. Adults aged 18 to 64 years meeting DSM-IV-TR criteria for GAD and insomnia.. Patients received 10 mg of escitalopram oxolate for 10 weeks and were randomized to also receive either 3 mg of eszopiclone (n = 294) or placebo (n = 301) nightly for 8 weeks. For the last 2 weeks, eszopiclone was replaced with a single-blind placebo.. Sleep, daytime functioning, psychiatric measures, and adverse events.. Compared with treatment with placebo and escitalopram, treatment with eszopiclone and escitalopram resulted in significantly improved sleep and daytime functioning (P < .05), with no evidence of tolerance. Patients taking eszopiclone and escitalopram had greater improvements in total Hamilton Anxiety Scale (HAM-A) scores at each week (P < .05) and at weeks 4 through 10 with the insomnia item removed. Clinical Global Impressions (CGI) of Improvement scores were improved with eszopiclone and escitalopram at every point (P < .02), while CGI of Severity of Illness scores were not significantly different after week 1. The HAM-A response (63% vs 49%, respectively, P = .001) and remission (42% vs 36%, respectively, P = .09) rates at week 8 were higher in patients treated with eszopiclone and escitalopram than those treated with placebo and escitalopram, and median time to onset of anxiolytic response was significantly reduced (P < or = .05). After eszopiclone discontinuation, there was no evidence of rebound insomnia, and while treatment differences in anxiety measures were maintained, differences in sleep outcomes were not. Overall adverse event rates were 77.6% with cotherapy and 67.9% with monotherapy. The most common adverse events with cotherapy were unpleasant taste, headache, dry mouth, and somnolence.. Coadministration of eszopiclone and escitalopram was well tolerated and associated with significantly improved sleep, daytime functioning, anxiety, and mood in patients with insomnia and GAD.. clinicaltrials.gov Identifier: NCT00235508.

Topics: Adolescent; Adult; Anxiety Disorders; Azabicyclo Compounds; Citalopram; Comorbidity; Diagnostic and Statistical Manual of Mental Disorders; Drug Therapy, Combination; Eszopiclone; Female; Humans; Hypnotics and Sedatives; Male; Middle Aged; Piperazines; Selective Serotonin Reuptake Inhibitors; Single-Blind Method; Sleep Initiation and Maintenance Disorders