Table 6.

Descriptives: Adverse Events

Variable	PLACEBO	ML 2.5SR	ML 10	OVERALL
Reporting at least 1 AE, %	69.2	79.6	74.0	74.4
Mean # AE reports x person*	2.4 ± 2.7	3.4 ± 3.4	2.0 ± 1.9	2.6 ± 2.8
Mean AE Severity†‡	1.4 ± 0.4	1.5 ± 0.6	1.5 ± 0.5	1.5 ± 0.5
Mean AE Serious§¦	2.0 ± 0.0	1.9 ± 0.3	1.9 ± 0.2	2.0 ± 0.21
Mean AE Relatedness¶	4.6 ± 0.6	4.5 ± 0.7	4.6 ± 0.6	4.6 ± 0.61

ML 2.5SR refers to treatment with 2.5 mg sustained-release melatonin; ML 10, treatment with 10 mg melatonin; AE, adverse events

^*2.5 vs ML 10: Z = −2.01, P = .04;

^†Severity: 1 = mild; 3 = severe.

^‡PLA vs 2.5, Z = −1.87, P = 0.06;

^§Serious: 1= serious; 2 = not serious.

^¶PLA vs ML 10: Z= −2.10, P = .04 (unadjusted P values)

^¦Relatedness: 1 = definitely related; 5 = not related.

Most frequently reported AE’s (>5% of total AEs for group):

Placebo: Abnormal behavior, ache/pain, falls, fatigue, gastrointestinal distress, infection, respiratory/pulmonary symptom, skin/subcutaneous tissue, urinary symptoms.

ML 2.5SR: Abnormal behavior, ache/pain, falls, gastrointestinal distress, infection, respiratory/pulmonary symptom, skin/subcutaneous tissue, urinary symptoms.

ML 10: Abnormal behavior, ache/pain, falls, gastrointestinal distress, respiratory/pulmonary symptom, skin/subcutaneous tissue, urinary symptoms.