Table 2.

Adverse Events, Shown As n (%)

	Varenicline (n = 486)	Placebo (n = 165)
Any adverse events	348 (71.6)	89 (53.9)
Severe adverse events	43 (8.8)	18 (10.9)
Serious adverse events	6 (1.2)	1 (0.6)
Deaths (all causes)	0	0
Study drug discontinuations due to adverse events
All causes	24 (4.9)	13 (7.9)
Nausea	5 (1.0)	0
Dose reductions or temporary discontinuations due to adverse events	53 (10.9)	5 (3.0)
Most frequent adverse events (≥5% in either group; except psychiatric adverse events)
GI disorders
Nausea	142 (29.2)	15 (9.1)
Infections and infestations
Nasopharyngitis	34 (7.0)	14 (8.5)
Nervous system disorders
Headache	55 (11.3)	20 (12.1)
Psychiatric adverse events (≥1% in any group)
Anxiety disorders and symptoms	13 (2.7)	8 (4.8)
Anxiety	4 (0.8)	5 (3.0)
Depressed mood disorders and disturbances	11 (2.3)	11 (6.7)
Depressed mood	5 (1.0)	5 (3.0)
Depression	4 (0.8)	5 (3.0)
Mood disorders and disturbances (not elsewhere) classified	8 (1.6)	2 (1.2)
Psychiatric disorders (not elsewhere classified)	2 (0.4)	2 (1.2)
Sleep disorders and disturbances	116 (23.9)	17 (10.3)
Abnormal dreams	61 (12.6)	5 (3.0)
Insomnia	43 (8.8)	6 (3.6)
Nightmare	8 (1.6)	2 (1.2)
Sleep disorder	20 (4.1)	6 (3.6)
Suicidal and self-injurious behaviors	1 (0.2)	2 (1.2)
Suicidal ideation	1 (0.2)	2 (1.2)

Note. Adverse events were defined as those that began or increased in severity during study drug treatment or up to 30 days after the last dose, irrespective of the causal relationship to study drug according to the investigator’s opinion.