PMID- 17557453
OWN - NLM
STAT- MEDLINE
DCOM- 20070724
LR  - 20221207
IS  - 1550-9389 (Print)
IS  - 1550-9389 (Linking)
VI  - 3
IP  - 1
DP  - 2007 Feb 15
TI  - Evaluation of eszopiclone discontinuation after cotherapy with fluoxetine for 
      insomnia with coexisting depression.
PG  - 48-55
AB  - BACKGROUND: Insomnia and major depressive disorder (MDD) may coexist. This study 
      evaluated hypnotic discontinuation effects following an 8-week placebo-controlled 
      study of eszopiclone/fluoxetine cotherapy in patients with insomnia and comorbid 
      MDD. METHODS: Patients meeting DSM-IV criteria for MDD and insomnia received 
      fluoxetine each morning for 8 weeks and were randomized to concomitant treatment 
      with nightly eszopiclone 3 mg (cotherapy) or placebo (monotherapy). Thereafter, 
      patients received 2 weeks of continued fluoxetine plus single-blind placebo. 
      RESULTS: Incidence rates of central nervous system (CNS) and potentially 
      CNS-related adverse events (AEs) during the run-out period were similar between 
      treatment groups (8.8% with monotherapy vs 9.8% with cotherapy), and there was no 
      evidence of benzodiazepine withdrawal AEs. Physician-assessed Clinical Global 
      Impression improvements in depressive symptoms were maintained after eszopiclone 
      discontinuation. Improvements in 17-item Hamilton-Depression Rating Scale 
      (HAMD-17) scores with cotherapy versus monotherapy seen at Week 8 (p = .0004) 
      were maintained at Week 10 (p < .0001) and significantly higher depression 
      response and remission rates were observed after cotherapy at Week 10 (p < .02). 
      Patients discontinued from eszopiclone maintained improvements in SL (sleep 
      latency), WASO (wake after sleep onset), and TST (total sleep time) during the 2 
      weeks following discontinuation (p < .05). CONCLUSIONS: In this study, 
      eszopiclone discontinuation did not result in significant CNS or benzodiazepine 
      withdrawal AEs, rebound insomnia, or rebound depression; and improvements in 
      sleep and depressive symptoms were maintained.
FAU - Krystal, Andrew
AU  - Krystal A
AD  - Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 
      Durham, NC 27710, USA. krystal@phy.duke.edu
FAU - Fava, Maurizio
AU  - Fava M
FAU - Rubens, Robert
AU  - Rubens R
FAU - Wessel, Thomas
AU  - Wessel T
FAU - Caron, Judy
AU  - Caron J
FAU - Wilson, Phebe
AU  - Wilson P
FAU - Roth, Thomas
AU  - Roth T
FAU - McCall, W Vaughn
AU  - McCall WV
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Sleep Med
JT  - Journal of clinical sleep medicine : JCSM : official publication of the American 
      Academy of Sleep Medicine
JID - 101231977
RN  - 0 (Azabicyclo Compounds)
RN  - 0 (Hypnotics and Sedatives)
RN  - 0 (Piperazines)
RN  - 0 (Serotonin Uptake Inhibitors)
RN  - 01K63SUP8D (Fluoxetine)
RN  - 03A5ORL08Q (zopiclone)
SB  - IM
MH  - Adult
MH  - Azabicyclo Compounds
MH  - Comorbidity
MH  - Depressive Disorder, Major/diagnosis/*drug therapy/*epidemiology
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Fluoxetine/adverse effects/*therapeutic use
MH  - Humans
MH  - Hypnotics and Sedatives/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Selective Serotonin Reuptake Inhibitors/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Single-Blind Method
MH  - Sleep Initiation and Maintenance Disorders/diagnosis/*drug therapy/*epidemiology
MH  - Time Factors
MH  - Withholding Treatment/*statistics & numerical data
EDAT- 2007/06/15 09:00
MHDA- 2007/07/25 09:00
CRDT- 2007/06/15 09:00
PHST- 2007/06/15 09:00 [pubmed]
PHST- 2007/07/25 09:00 [medline]
PHST- 2007/06/15 09:00 [entrez]
PST - ppublish
SO  - J Clin Sleep Med. 2007 Feb 15;3(1):48-55.