Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder.
BACKGROUND
Insomnia and generalized anxiety disorder (GAD) are prevalent disorders that may coexist.


OBJECTIVE
To determine the efficacy of eszopiclone combined with escitalopram oxalate in treating insomnia comorbid with GAD.


METHODS
Double-blind, randomized, placebo-controlled, parallel-group, add-on therapy 10-week study.


METHODS
Multicenter outpatient study from July 2005 to April 2006.


METHODS
Adults aged 18 to 64 years meeting DSM-IV-TR criteria for GAD and insomnia.


METHODS
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.


METHODS
Sleep, daytime functioning, psychiatric measures, and adverse events.


RESULTS
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.


CONCLUSIONS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00235508.
Pollack
Mark
M
Massachusetts General Hospital, Simches Research Bldg, 185 Cambridge St, Ste 2200, 2nd Floor, Boston, MA 02114, USA. mpollack@partners.org
Kinrys
Gustavo
G
Krystal
Andrew
A
McCall
W Vaughn
WV
Roth
Thomas
T
Schaefer
Kendyl
K
Rubens
Robert
R
Roach
James
J
Huang
Holly
H
Krishnan
Ranga
R
D000293:Adolescent; D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D053961:Azabicyclo Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004359:Drug Therapy, Combination; D000069582:Eszopiclone; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000453:epidemiology*
D053961:Azabicyclo Compounds; D015283:Citalopram; D000069582:Eszopiclone; D006993:Hypnotics and Sedatives; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors