Table 4.

Summary of AEs

AE	Study P008		Study P038
	Ketoconazole studya,b		Diltiazem sub-studya,c		Rifampin sub-studya,c
	Suvorexant 4 mg (N = 10)	Suvorexant 4 mg + ketoconazole (N = 10)	Suvorexant 20 mg (N = 20)	Suvorexant 20 mg + diltiazem (N = 20)	Suvorexant 40 mg (N = 10)	Suvorexant 40 mg + rifampin (N = 10)
Subjects with ≥ 1 AE, n (%)	6 (60)	7 (70)	20 (100)	18 (90)	10 (100)	10 (100)
AEs reported by ≥ 2 subjects, any treatment group, n (%)
Somnolence	6 (60)	7 (70)	19 (95)	17 (85)	10 (100)	9 (90)
Headache	0 (0)	1 (10)	0 (0)	1 (5)	1 (10)	2 (20)
Vessel puncture site hematoma	0 (0)	0 (0)	1 (5)	1 (5)	3 (30)	0 (0)
Diarrhea	0 (0)	0 (0)	2 (10)	0 (0)	0 (0)	0 (0)
Nausea	0 (0)	0 (0)	2 (10)	0 (0)	0 (0)	0 (0)
Abnormal dreams	0 (0)	0 (0)	1 (5)	1 (5)	2 (20)	3 (30)
ECI, n (%)
Euphoric mood	0 (0)	0 (0)	0 (0)	1 (5)	1 (10)	0 (0)
Hypnagogic hallucination	0 (0)	0 (0)	0 (0)	0 (0)	1 (10)	0 (0)
Hypnopompic hallucination	0 (0)	0 (0)	0 (0)	0 (0)	1 (10)	0 (0)
Sleep paralysis	0 (0)	0 (0)	0 (0)	0 (0)	1 (10)	0 (0)

AE adverse event, ECI event of clinical interest, MedDRA Medical Dictionary for Regulatory Activities

^aAlthough a subject may have had two or more AEs, the subject is counted only once in that category. The same subject may appear in different categories

^bMedDRA Version 12.0

^cMedDRA Version 13.1