Table 5.

Adverse drug reactions by demographic characteristic (safety analysis population)

Items	N	Number of patients with events	Number of events	Rate of occurrence (%)
Overall	3248	315	377	9.7
Sex
Male	1271	129	147	10.1
Female	1977	186	230	9.4
Age group 1 (years)
< 15	2	0	0	0.0
≥ 15 to < 65	1488	168	206	11.3
≥ 65	1758	147	171	8.4
Age group 2 (years)
< 65	1490	168	206	11.3
≥ 65 to < 75	730	63	76	8.6
≥ 75	1028	84	95	8.2
Age group 3 (years)
< 65	1490	168	206	11.3
≥ 65 to < 85	1490	126	147	8.5
≥ 85	268	21	24	7.8
BMI (kg/m2)
< 25.0	1357	135	160	9.9
≥ 25.0	497	52	66	10.5
Unknown	1394	128	151	9.2
Reason for use (multi-count)
Difficulty falling asleep	2429	217	264	8.9
Nocturnal awakening	1596	176	215	11.0
Early morning awakening	349	43	52	12.3
Others	31	8	10	25.8
Duration of insomnia (years)
< 1	1313	116	139	8.8
≥ 1 to < 10	1481	149	181	10.1
≥ 10	454	50	57	11.0
Medical examinationa
Psychiatry	917	127	157	13.8
Internal medicine	2004	150	171	7.5
Others	327	38	49	11.6
Narcolepsy-like events
No	3113	303	361	9.7
Yes	92	9	11	9.8
Unknown	43	3	5	7.0
Diagnosis of narcolepsy (including cataplexy)
No	3206	311	373	9.7
Suspected	4	1	1	25.0
Yes	1	0	0	0.0
Unknown	37	3	3	8.1
Respiratory dysfunction
No	2866	274	332	9.6
Yes	121	10	10	8.3
Unknown	261	31	35	11.9
Chronic obstructive pulmonary disease (COPD)
No	3077	301	361	9.8
Yes	50	2	2	4.0
Unknown	121	12	14	9.9
Obstructive sleep apnea (OSA)
No	2919	275	333	9.4
Yes	73	8	8	11.0
Unknown	256	32	36	12.5
Severe respiratory dysfunction
No	2959	282	340	9.5
Yes	28	2	2	7.1
Unknown	261	31	35	11.9
Hepatic function disorder
No	2984	276	331	9.2
Yes	141	22	25	15.6
Unknown	123	17	21	13.8
Severe hepatic function disorder
No	3120	297	355	9.5
Yes	5	1	1	20.0
Unknown	123	17	21	13.8
Structural brain disorder
No	3142	307	367	9.8
Yes	106	8	10	7.5
Psychiatric disorder
No	2182	166	190	7.6
Yes	1007	144	181	14.3
Unknown	59	5	6	8.5
Schizophrenia
No	3095	296	350	9.6
Yes	92	13	20	14.1
Unknown	61	6	7	9.8
Depression
No	2680	239	282	8.9
Yes	508	70	88	13.8
Unknown	60	6	7	10.0
Manic-depressive illness
No	3103	298	356	9.6
Yes	84	11	14	13.1
Unknown	61	6	7	9.8
Anxiety disorder
No	2976	282	332	9.5
Yes	211	27	38	12.8
Unknown	61	6	7	9.8
Dementia
No	3043	300	358	9.9
Yes	144	9	12	6.3
Unknown	61	6	7	9.8
Medical history
No	2498	224	268	9.0
Yes	543	69	82	12.7
Unknown	207	22	27	10.6
Prior medication
No	1946	132	157	6.8
Yes	1277	182	219	14.3
Unknown	25	1	1	4.0
Concomitant medication
No	982	47	57	4.8
Yes	2241	267	319	11.9
Unknown	25	1	1	4.0
Concomitant insomnia medication
No	2335	192	225	8.2
Yes	888	122	151	13.7
Unknown	25	1	1	4.0
Initiation status
Naïve	1946	132	157	6.8
Switch	703	110	137	15.6
Add-on	536	68	76	12.7
Others	63	5	7	7.9

BMI body mass index

^aPsychiatric and psychosomatic medicines are given as ‘psychiatry’