Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors.
This study involves the analysis of a secondary outcome of a trial examining whether cognitive behavior therapy for insomnia (CBT-I), a wake-promoting medication (armodafinil), or both results in greater improvement in prospectively assessed sleep continuity and daytime sleepiness than a placebo-alone group among a heterogeneous group of cancer survivors. Whether or not armodafinil alone, and/or when combined with CBT-I, affected adherence with CBT-I was evaluated.



This study is a randomized, placebo-controlled, clinical trial.



This study was conducted at two northeastern academic medical centers.



Eighty-eight cancer survivors with chronic insomnia were recruited between October 2008 and November 2012. Participants were assigned to one of four conditions: 1) CBT-I and placebo (CBT-I+P); 2) CBT-I and armodafinil (CBT-I + A); 2) armodafinil alone (ARM); or 4) placebo alone (PLA).



CBT-I was delivered in seven weekly individual therapy sessions (three in person, four via telephone). The armodafinil dosage was 50 mg BID.



Sleep continuity was measured with daily sleep diaries assessing sleep latency (SL), wake after sleep onset (WASO), and total sleep time (TST). The Epworth Sleepiness Scale (ESS) measured daytime sleepiness. Compared to the PLA group, the CBT-I+P and CBT-I+A groups reported a significant reduction in SL with effect sizes of 0.67 and 0.58, respectively. A significant reduction was observed in WASO in the CBT-I+A group with an effect size of 0.64. An increasing trend of TST was observed in the CBT-I+P, CBT-I+A, and PLA groups, but not in the ARM group. No statistically significant reductions in daytime sleepiness (ESS) were observed for any of the groups.



CBT-I alone and in combination with armodafinil caused significant improvement in sleep continuity. The addition of armodafinil did not appear to improve daytime sleepiness or enhance adherence to CBT-I.
Department of Family Medicine and Community Health, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA; Abramson Cancer Center, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, USA; Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA; Department of Psychology, Memorial University of Newfoundland, 232 Elizabeth Avenue, St. John's, NL A1B 3X9, Canada. Electronic address: sheila.garland@mun.ca.
Sheila N
SN
Garland
James P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Joseph A
JA
Roscoe
James P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Charles E
CE
Heckler
Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA.
Holly
H
Barilla
Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA.
Philip
P
Gehrman
Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA.
James C
JC
Findley
James P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Anita R
AR
Peoples
James P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Gary R
GR
Morrow
James P. Wilmot Cancer Center, University of Rochester, 265 Crittenden Blvd. CU 420658, Rochester, NY 14642, USA.
Charles
C
Kamen
Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA. Electronic address: mperlis@exchange.upenn.edu.
Michael L
ML
Perlis
D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D006970:Disorders of Excessive Somnolence / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009369:Neoplasms / Q000150:complications*; D007319:Sleep Initiation and Maintenance Disorders / Q000150:complications*; D012894:Sleep Stages; D017741:Survivors; D064690:Wakefulness-Promoting Agents / Q000627:therapeutic use*
D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil
Armodafinil; CBT-I; Cancer; Cognitive behavior therapy; Insomnia; Sleepiness