PMID- 20007734
OWN - NLM
STAT- MEDLINE
DCOM- 20100208
LR  - 20141120
IS  - 1526-7598 (Electronic)
IS  - 0003-2999 (Linking)
VI  - 110
IP  - 2
DP  - 2010 Feb 1
TI  - The effects of nabilone on sleep in fibromyalgia: results of a randomized 
      controlled trial.
PG  - 604-10
LID - 10.1213/ANE.0b013e3181c76f70 [doi]
AB  - BACKGROUND: Sleep disorders affect many patients with chronic pain conditions. 
      Cannabis has been reported by several patient populations to help sleep. We 
      evaluated the safety and efficacy of nabilone, a synthetic cannabinoid, on sleep 
      disturbance in fibromyalgia (FM), a disease characterized by widespread chronic 
      pain and insomnia. METHODS: We conducted a randomized, double-blind, 
      active-control, equivalency crossover trial to compare nabilone (0.5-1.0 mg 
      before bedtime) to amitriptyline (10-20 mg before bedtime) in patients with FM 
      with chronic insomnia. Subjects received each drug for 2 wk with a 2-wk washout 
      period. The primary outcome was sleep quality, measured by the Insomnia Severity 
      Index and the Leeds Sleep Evaluation Questionnaire. Secondary outcomes included 
      pain, mood, quality of life, and adverse events (AEs). RESULTS: Thirty-one 
      subjects were enrolled and 29 completed the trial (26 women, mean age 49.5 yr). 
      Although sleep was improved by both amitriptyline and nabilone, nabilone was 
      superior to amitriptyline (Insomnia Severity Index difference = 3.2; 95% 
      confidence interval = 1.2-5.3). Nabilone was marginally better on the restfulness 
      (Leeds Sleep Evaluation Questionnaire difference = 0.5 [0.0-1.0]) but not on 
      wakefulness (difference = 0.3 [-0.2 to 0.8]). No effects on pain, mood, or 
      quality of life were observed. AEs were mostly mild to moderate and were more 
      frequent with nabilone. The most common AEs for nabilone were dizziness, nausea, 
      and dry mouth. CONCLUSIONS: Nabilone is effective in improving sleep in patients 
      with FM and is well tolerated. Low-dose nabilone given once daily at bedtime may 
      be considered as an alternative to amitriptyline. Longer trials are needed to 
      determine the duration of effect and to characterize long-term safety.
FAU - Ware, Mark A
AU  - Ware MA
AD  - Pain Clinic, McGill University Health Centre, Montreal, Quebec, Canada. 
      mark.ware@muhc.mcgill.c
FAU - Fitzcharles, Mary-Ann
AU  - Fitzcharles MA
FAU - Joseph, Lawrence
AU  - Joseph L
FAU - Shir, Yoram
AU  - Shir Y
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20091210
PL  - United States
TA  - Anesth Analg
JT  - Anesthesia and analgesia
JID - 1310650
RN  - 0 (Anti-Anxiety Agents)
RN  - 0 (Antidepressive Agents)
RN  - 1806D8D52K (Amitriptyline)
RN  - 2N4O9L084N (nabilone)
RN  - 7J8897W37S (Dronabinol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amitriptyline/therapeutic use
MH  - Anti-Anxiety Agents/adverse effects/*therapeutic use
MH  - Antidepressive Agents
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Dronabinol/adverse effects/*analogs & derivatives/therapeutic use
MH  - Female
MH  - Fibromyalgia/*complications
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Patient Satisfaction
MH  - Sleep
MH  - Sleep Initiation and Maintenance Disorders/*drug therapy/etiology
EDAT- 2009/12/17 06:00
MHDA- 2010/02/09 06:00
CRDT- 2009/12/17 06:00
PHST- 2009/12/17 06:00 [entrez]
PHST- 2009/12/17 06:00 [pubmed]
PHST- 2010/02/09 06:00 [medline]
AID - ANE.0b013e3181c76f70 [pii]
AID - 10.1213/ANE.0b013e3181c76f70 [doi]
PST - ppublish
SO  - Anesth Analg. 2010 Feb 1;110(2):604-10. doi: 10.1213/ANE.0b013e3181c76f70. Epub 
      2009 Dec 10.