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

Table 3

Intention-to-treat analysis of adverse events in 211 patients.

	Armodafinil 𝑛 (%)	Modafinil 𝑛 (%)	𝑃
Cardiovascular
Palpitation	6 (5.71)	9 (8.49)	.59
Hypertension	4 (3.81)	8 (7.55)	.37
Angina	0 (0)	0 (0)	NA
Dermatologic
Skin rash	1 ( 0.95)	0 (0)	.48
Contact dermatitis	0 (0)	0 (0)	NA
Gastrointestinal
Nausea	13 (12.38)	11 (10.38)	.67
Vomiting	1 (0.95)	2 (1.89)	1.00
Dry mouth	15 (14.29)	19 (17.92)	.58
Dyspepsia	6 (5.71)	9 (8.49)	.59
Constipation	11 (10.48)	5 (4.72)	.13
Abdominal pain	4 (3.81)	5 (4.72)	1.00
Diarrhea	0 (0)	4 (3.77)	.12
Psychiatric
Insomnia	5 (4.76)	11 (10.38)	.20
Anxiety	7 (6.67)	9 (8.49)	.80
Depression	2 (1.90)	0 (0)	.25
Agitation	3 (2.86)	6 (5.66)	.50
Nervousness	10 (9.52)	4 (3.77)	.10
Depressed mood	4 (3.81)	0 (0)	.06
Neurological
Dizziness	2 (1.90)	8 (7.55)	.10
Disturbance in attention	3 (2.86)	2 (1.89)	.68
Tremor	3 (2.86)	7 (6.60)	.33
Headache	14 (13.33)	15 (14.15)	1.00
Migraine	1 (0.95)	0 (0)	.48
Paraesthesia	0 (0)	0 (0)	NA
General
Fatigue	4 (3.81)	4 (3.77)	1.00
Thirst	12 (11.43)	6 (5.66)	.15
Influenza like illness	0 (0)	0 (0)	NA
Fever	1 (0.95)	0 (0)	.48
Total no. of patients with adverse events	45 ( 42.85)	43 (40.57)	.78

Fisher’s exact test; 𝑃<.05 = statistically significant.