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. 2018 Dec 14;19(1):27–46. doi: 10.1007/s40268-018-0256-6

Table 6.

Final overall global improvement by demographic characteristic (physician’s assessment) (efficacy analysis population)

Items Number of patients by characteristic Improved patients Unchanged patients Deteriorated patients
N % N % N %
Overall 2439 1806 74.0 542 22.2 91 3.7
Sex
 Male 943 686 72.7 218 23.1 39 4.1
 Female 1496 1120 74.9 324 21.7 52 3.5
Age group 1 (years)
 < 65 997 731 73.3 226 22.7 40 4.0
 ≥ 65 1442 1075 74.5 316 21.9 51 3.5
Age group 2 (years)
 < 65 997 731 73.3 226 22.7 40 4.0
 ≥ 65 to < 75 565 417 73.8 128 22.7 20 3.5
 ≥ 75 877 658 75.0 188 21.4 31 3.5
Age group 3 (years)
 < 65 997 731 73.3 226 22.7 40 4.0
 ≥ 65 to < 85 1213 898 74.0 273 22.5 42 3.5
 ≥ 85 229 177 77.3 43 18.8 9 3.9
BMI (kg/m2)
 < 25.0 1046 782 74.8 233 22.3 31 3.0
 ≥ 25.0 377 276 73.2 82 21.8 19 5.0
 Unknown 1016 748 73.6 227 22.3 41 4.0
Reason for use (multi-count)
 Difficulty falling asleep 1826 1356 74.3 410 22.5 60 3.3
 Nocturnal awakening 1222 908 74.3 262 21.4 52 4.3
 Early morning awakening 261 190 72.8 59 22.6 12 4.6
 Others 22 16 72.7 5 22.7 1 4.5
Duration of insomnia (years)
 < 1 968 756 78.1 189 19.5 23 2.4
 ≥ 1 to < 10 1124 814 72.4 262 23.3 48 4.3
 ≥ 10 347 236 68.0 91 26.2 20 5.8
Medical examinationa
 Psychiatry 689 492 71.4 167 24.2 30 4.4
 Internal medicine 1515 1139 75.2 320 21.1 56 3.7
 Others 235 175 74.5 55 23.4 5 2.1
Narcolepsy-like events
 No 2344 1746 74.5 513 21.9 85 3.6
 Yes 63 43 68.3 16 25.4 4 6.3
 Unknown 32 17 53.1 13 40.6 2 6.3
Diagnosis of narcolepsy (including cataplexy)
 No 2404 1784 74.2 531 22.1 89 3.7
 Suspected 2 1 50.0 1 50.0 0 0.0
 Yes 1 0 0.0 1 100.0 0 0.0
 Unknown 32 21 65.6 9 28.1 2 6.3
Respiratory dysfunction
 No 2151 1611 74.9 461 21.4 79 3.7
 Yes 102 78 76.5 22 21.6 2 2.0
 Unknown 186 117 62.9 59 31.7 10 5.4
Chronic obstructive pulmonary disease (COPD)
 No 2306 1711 74.2 508 22.0 87 3.8
 Yes 44 37 84.1 7 15.9 0 0.0
 Unknown 89 58 65.2 27 30.3 4 4.5
Obstructive sleep apnea (OSA)
 No 2197 1647 75.0 471 21.4 79 3.6
 Yes 60 43 71.7 15 25.0 2 3.3
 Unknown 182 116 63.7 56 30.8 10 5.5
Severe respiratory dysfunction
 No 2230 1670 74.9 479 21.5 81 3.6
 Yes 23 19 82.6 4 17.4 0 0.0
 Unknown 186 117 62.9 59 31.7 10 5.4
Hepatic function disorder
 No 2254 1680 74.5 491 21.8 83 3.7
 Yes 106 75 70.8 27 25.5 4 3.8
 Unknown 79 51 64.6 24 30.4 4 5.1
Severe hepatic function disorder
 No 2356 1752 74.4 517 21.9 87 3.7
 Yes 4 3 75.0 1 25.0 0 0.0
 Unknown 79 51 64.6 24 30.4 4 5.1
Structural brain disorder
 No 2357 1740 73.8 529 22.4 88 3.7
 Yes 82 66 80.5 13 15.9 3 3.7
Psychiatric disorder
 No 1642 1246 75.9 343 20.9 53 3.2
 Yes 756 534 70.6 185 24.5 37 4.9
 Unknown 41 26 63.4 14 34.1 1 2.4
Schizophrenia
 No 2321 1728 74.5 507 21.8 86 3.7
 Yes 76 52 68.4 21 27.6 3 3.9
 Unknown 42 26 61.9 14 33.3 2 4.8
Depression
 No 2012 1500 74.6 441 21.9 71 3.5
 Yes 386 280 72.5 87 22.5 19 4.9
 Unknown 41 26 63.4 14 34.1 1 2.4
Manic-depressive illness
 No 2333 1742 74.7 505 21.6 86 3.7
 Yes 64 38 59.4 23 35.9 3 4.7
 Unknown 42 26 61.9 14 33.3 2 4.8
Anxiety disorder
 No 2243 1669 74.4 492 21.9 82 3.7
 Yes 154 111 72.1 36 23.4 7 4.5
 Unknown 42 26 61.9 14 33.3 2 4.8
Dementia
 No 2279 1692 74.2 505 22.2 82 3.6
 Yes 118 88 74.6 23 19.5 7 5.9
 Unknown 42 26 61.9 14 33.3 2 4.8
Medical history
 No 1875 1398 74.6 413 22.0 64 3.4
 Yes 403 286 71.0 98 24.3 19 4.7
 Unknown 161 122 75.8 31 19.3 8 5.0
Prior medication
 No 1446 1136 78.6 281 19.4 29 2.0
 Yes 976 659 67.5 256 26.2 61 6.3
 Unknown 17 11 64.7 5 29.4 1 5.9
Concomitant medication
 No 727 572 78.7 136 18.7 19 2.6
 Yes 1695 1223 72.2 401 23.7 71 4.2
 Unknown 17 11 64.7 5 29.4 1 5.9
Concomitant insomnia medication
 No 1756 1336 76.1 364 20.7 56 3.2
 Yes 666 459 68.9 173 26.0 34 5.1
 Unknown 17 11 64.7 5 29.4 1 5.9
Initiation status
 Naïve 1446 1136 78.6 281 19.4 29 2.0
 Switch 538 344 63.9 151 28.1 43 8.0
 Add-on 410 292 71.2 101 24.6 17 4.1
 Others 45 34 75.6 9 20.0 2 4.4

Totals will not be 100% due to rounding

BMI body mass index

aPsychiatric and psychosomatic medicines are given as ‘psychiatry’