TABLE 2

Adverse events reported during the 1-month trial

PlaceboZopiclone#Related to zopiclone
MinorSeriousMinorSerious
Abnormal dreams2/161/15Probably
Abscess drainage1/15No
Anxiety1/15Possibly
Balance disorder1/15Probably
Bradycardia1/16
Change in sleep pattern3/16
Constipation1/16
Decreased appetite2/15Probably
Diarrhoea1/15Probably
Disturbance in memory or attention2/15Probably
Dysgeusia3/15Definite
Fatigue or asthenia1/161/15Probably
Feeling abnormal2/15Probably
Headache or migraine2/15Probably
Insomnia2/15Possibly
Joint swelling1/15No
Loss of libido1/15Probably
Muscle ache or injury1/161/15No
Nasopharyngitis2/161/15No
Oral ulcer1/16
Rash2/16
Stress1/15Possibly
Weight loss2/15Possibly

Data represent adverse events reported during the 1-month trial or during the week after completion. None of these events required withdrawal from the study. A total of seven out of 16 participants randomised to placebo and 14 out of 15 randomised to zopiclone reported adverse events during the 1-month trial. Six participants in the placebo group and eight in the zopiclone group reported more than one adverse event. #: one participant from the zopiclone group withdrew from the study prior to completing the 1-month trial due to nonmedical issues; : whether each adverse event was related to zopiclone was determined by a physician according to the following criteria: not related (“No”), unlikely, possibly, probably or definitely.