PMID- 26047892
OWN - NLM
STAT- MEDLINE
DCOM- 20160321
LR  - 20181202
IS  - 1878-5506 (Electronic)
IS  - 1389-9457 (Linking)
VI  - 16
IP  - 7
DP  - 2015 Jul
TI  - Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and 
      safety from a randomized, 6-week sleep laboratory trial.
PG  - 838-44
LID - S1389-9457(15)00697-8 [pii]
LID - 10.1016/j.sleep.2015.04.001 [doi]
AB  - OBJECTIVE: Esmirtazapine (Org 50081), a medication that binds with high affinity 
      to serotonin 5-HT2A and histamine-1 receptors, was evaluated as a potential 
      treatment for insomnia. METHODS: Adults with primary insomnia were treated with 
      esmirtazapine (3.0 or 4.5 mg) or placebo in this 6-week, double-blind, 
      randomized, polysomnography (PSG) study. The end points included wake time after 
      sleep onset (WASO) (primary), latency to persistent sleep, and total sleep time. 
      Patient-reported parameters were also evaluated, including sleep quality and 
      satisfaction with sleep duration. Residual daytime effects and rebound insomnia 
      (sleep parameters during the single-blind placebo run-out week after treatment 
      ended) were also assessed. RESULTS: Overall, 419 patients were randomized and 366 
      (87%) completed treatment. The median decrease in PSG WASO (double-blind average) 
      was 20.5 min for placebo, and 52.0 min and 53.6 min for the 3.0- and 4.5-mg 
      esmirtazapine groups, respectively (P < 0.0001 vs. placebo for both doses). 
      Changes in the other PSG parameters and in all patient-reported parameters were 
      also statistically significant with both doses versus placebo. Overall, 35-42% of 
      esmirtazapine-treated patients had adverse events (AEs) versus 29% in the placebo 
      group. AEs were mild or moderate in most esmirtazapine-treated patients. 
      Furthermore, the incidence of AEs leading to discontinuation was low (<8%). 
      CONCLUSIONS: Six weeks of treatment with esmirtazapine was associated with 
      consistent improvements in objective and patient-reported parameters of sleep 
      onset, maintenance, and duration. It was generally well tolerated, and residual 
      daytime effects were minimal and no rebound insomnia was observed.
CI  - Copyright (c) 2015. Published by Elsevier B.V.
FAU - Ivgy-May, Neely
AU  - Ivgy-May N
AD  - Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: mayneely@gmail.com.
FAU - Ruwe, Frank
AU  - Ruwe F
AD  - MSD, Oss, The Netherlands.
FAU - Krystal, Andrew
AU  - Krystal A
AD  - Duke University School of Medicine, Durham, NC, USA.
FAU - Roth, Thomas
AU  - Roth T
AD  - Henry Ford Hospital, Detroit, MI, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150416
PL  - Netherlands
TA  - Sleep Med
JT  - Sleep medicine
JID - 100898759
RN  - 0 (Hypnotics and Sedatives)
RN  - 250PJI13LM (Mianserin)
RN  - A051Q2099Q (Mirtazapine)
SB  - IM
MH  - Adult
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypnotics and Sedatives/adverse effects/*therapeutic use
MH  - Male
MH  - Mianserin/adverse effects/*analogs & derivatives/therapeutic use
MH  - Middle Aged
MH  - Mirtazapine
MH  - Patient Satisfaction
MH  - *Polysomnography
MH  - Recurrence
MH  - Sleep Initiation and Maintenance Disorders/diagnosis/*drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Clinical trial
OT  - Esmirtazapine
OT  - Insomnia
OT  - Polysomnography
OT  - Sleep maintenance
EDAT- 2015/06/07 06:00
MHDA- 2016/03/22 06:00
CRDT- 2015/06/07 06:00
PHST- 2015/01/23 00:00 [received]
PHST- 2015/03/27 00:00 [revised]
PHST- 2015/04/05 00:00 [accepted]
PHST- 2015/06/07 06:00 [entrez]
PHST- 2015/06/07 06:00 [pubmed]
PHST- 2016/03/22 06:00 [medline]
AID - S1389-9457(15)00697-8 [pii]
AID - 10.1016/j.sleep.2015.04.001 [doi]
PST - ppublish
SO  - Sleep Med. 2015 Jul;16(7):838-44. doi: 10.1016/j.sleep.2015.04.001. Epub 2015 Apr 
      16.