Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial

Abstract

Aim. To compare the efficacy and safety of armodafinil, the R-enantiomer of modafinil, with modafinil in patients of shift work sleep disorder (SWSD). Material and Methods. This was a 12-week, randomized, comparative, double-blind, multicentric, parallel-group study in 211 patients of SWSD, receiving armodafinil (150 mg) or modafinil (200 mg) one hour prior to the night shift. Outcome Measures. Efficacy was assessed by change in stanford sleepiness score (SSS) by at least 2 grades (responder) and global assessment for efficacy. Safety was assessed by incidence of adverse events, change in laboratory parameters, ECG, and global assessment of tolerability. Results. Both modafinil and armodafinil significantly improved sleepiness mean grades as compared to baseline (P < .0001). Responder rates with armodafinil (72.12%) and modafinil (74.29%) were comparable (P = .76). Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg.

Efficacy and tolerability of adjunctive modafinil/armodafinil in bipolar depression: A meta‐analysis of randomized controlled trials

“…Our findings examining the use of MoArm in affective disorders and its association with individual adverse events are similar to the adverse events with armodafinil for the treatment of excessive sleepiness associated with narcolepsy, sleep work shift disorder and a previous meta‐analysis of dopaminergic agents in bipolar depression . However, our data showed an increased risk for nausea and dry mouth and a lower risk for weight gain, which could constitute a consideration for patients with bipolar depression treated with weight liable pharmacotherapy.…”

“…24 Our meta-analysis specifically examined the efficacy and rates for all-cause discontinuation, risk of mood destabilization and suicidality, with augmentation of MoArm in bipolar depression including data from three recent RCTs. 34 Our findings examining the use of MoArm in affective disorders and its association with individual adverse events are similar to the adverse events with armodafinil for the treatment of excessive sleepiness associated with narcolepsy, 52 sleep work shift disorder 53 and a previous meta-analysis of dopaminergic agents in bipolar depression. 14 49 A better solution to the statistical significance dilemma could be to also consider and include the LHH in the efficacy analysis of clinical trials to evaluate if high LHH value is associated with a positive treatment outcome.…”

A scoping review of the evidence for the impact of pharmacological and non-pharmacological interventions on shift work related sleep disturbance in an occupational setting

“…Figure 1 presents a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram showing reasons for study exclusions. In total, eight of the included trials were randomised controlled trials 12,[14][15][16][17][18][19][20][21] . The remainder were cross-over [22][23][24] and a parallel group design [25][26][27] .…”

“…Studies included those with rotating and fixed shifts. Five trials applied ICSD criteria for SWD in use at the time of the study; these were all studies of stimulants 12,14,15,20,26,27 . Interventions evaluated were hypnotic [21][22][23][24][25] and stimulant drugs 12,14,15,20,26,27 , cognitive behaviour therapy 17 , aromatherapy 18 , light therapy 19 and Shimian granules (a form of a Chinese herbal medicine) 16 .…”

Circadian rhythm sleep disorders

“…No objective measures of sleepiness were used. 61 In another trial, caffeine at a dose of 4 mg/kg administered 30 minutes prior to a night shift, resulted in objective improvements in performance and alertness. 62 …”