Options: Hide MedDRA Preferred Terms
MedDRA Preferred Term | Side effect | Data for drug | Placebo | Labels |
---|---|---|---|---|
1 | ||||
Somnolence | Drowsiness | 12% | 3% | x |
Headache | Headache | 5% | 2% | x |
Dizziness | Dizziness | 2% | 1% | x |
Asthenia | Fatigue | 2% | 0% | x |
Fatigue | Fatigue | 2% | 0% | x |
Dry mouth | Dry mouth | 2% | 1% | x |
Dyspepsia | Dyspepsia | 1% | 1% | x |
Withdrawal syndrome | Withdrawal syndrome | x | ||
Thinking abnormal | Thinking abnormal | x | ||
Mental disability | Thinking abnormal | x |
Information about indications was extracted from the indications and usage sections of the labels.
Indication | Labels | |||
---|---|---|---|---|
Chronic insomnia | x | |||
Insomnia | x |
standard – alternative
100% | ||
75% | ||
50% | ||
10% | ||
frequent (1% to 100%) | ||
infrequent (0.1% to 1%) | ||
rare (<0.1%) | ||
postmarketing | ||
0% | ||
no frequency information | ||
not found on label |