Modafinil is a psychostimulant effective in the treatment of excessive sleepiness associated with narcolepsy and in people with shift-work sleep disorder. It is used to increase wakefulness and capacity for attention, to brighten mood, and to enhance memory. Modafinil comes as a tablet for oral intake and has been evaluated in patients with cancer for fatigue and cognitive impairment.
Armodafinil is a similar drug with a slightly different chemical configuration also used as a wakefulness-promoting agent. Armodafinil reaches peak concentration in the blood later after administration than modafinil. Armodafinil has been studied for its effect on fatigue, anxiety, sleep-wake disturbances, and depression in people with cancer.
Heckler, C.E., Garland, S.N., Peoples, A.R., Perlis, M.L., Shayne, M., Morrow, G.R., . . . Roscoe, J.A. (2016). Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: A randomized placebo-controlled trial. Supportive Care in Cancer, 24, 2059–2066.
To assess the combined and comparative effect of cognitive behavioral therapy (CBT) and armodafinil to improve sleep and daytime functioning in survivors of cancer.
Participants were randomized to (a) CBT-I and placebo, (b) CBT-I and armodafinil 50 mg b.i.d., (c) placebo BID, or (d) armodafinil 50 mg BID. All received written sleep hygiene guidelines. Participants had CBT-I in 30–60-minute individual, in-person sessions during weeks 1, 2, and 4; and had 15–30-minute phone sessions during weeks 3, 5, and 7. Study medicine was taken for 47 days from 7 am to 9 am and 12 pm to 2 pm.
Improvement in fatigue was noted with CBT for insomnia (p = 0.002 on BFI; p < 0.001 on FACIT-F). No improvement in fatigue was noted with placebo, on armodafinil alone, or on armodafinil with CBT-I.
CBT for insomnia appears to improve fatigue in patients with insomnia, and armodafinil was not shown to improve fatigue in patients with insomnia and fatigue.
This study shows that CBT for insomnia may be beneficial to patients with fatigue and that armodafinil does not improve fatigue.
Roscoe, J.A., Garland, S.N., Heckler, C.E., Perlis, M.L., Peoples, A.R., Shayne, M., . . . Morrow, G.R. (2015). Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. Journal of Clinical Oncology, 33, 165–171.
To evaluate whether cognitive behavioral therapy for insomnia (CBT-I) in combination with a wakefulness-promoting agent, armodafinil, results in better insomnia outcomes in cancer survivors compared to CBTI-I alone
Randomized, placebo-controlled trial
Analyses controlling for baseline differences showed that both the CBT-I plus armodafinil (p = 0.001) and CBT-I plus placebo (p = 0.010) groups experienced significantly greater reductions in insomnia severity postintervention than the placebo group with effect sizes of 1.31 and 1.02, respectively. Similar improvements were seen for sleep quality. Gains on both measures persisted three months later. CBT-I plus armodafinil was not significantly different from CBT-I plus a placebo (p = 0.421), and armodafinil alone was not significantly different from a placebo alone (p = 0.584).
Considering the prevalence of insomnia in patients with cancer and survivors, the potential for poorer outcomes if insomnia remains untreated, and the efficacy of CBT-I in treating chronic insomnia, it is desirable that providers and patients obtain increased access to evidence-based nonpharmacologic sleep interventions as an integral part of comprehensive cancer care. The findings of this study demonstrated that the addition of armodafinil to CBT-I treatment did not improve results for sleep.