Background and aims Sleep disorders, like difficulties falling asleep or maintaining sleep, are very common in children. Inadequate sleep may impact children’s development, mood and behaviour and in consequence the wellbeing of their parents and caregivers. In a prospective, randomised, multicenter, open, comparative clinical trial the effectiveness of homeopathic ZinCyp-3–02 tablets (Cypripedium pubescens D4, Magnesium carbonicum D10, Zincum valerianicum D12) in children with sleep disorders and restlessness was evaluated.

Methods Children aged≤6 years, suffering from sleep disorders for≥1 month, were randomised to receive either ZinCyp-3–02 tablets (intervention) or the aminoacetic acid glycine (control) for 28 days. Effectiveness endpoints included the change of 7 sleep related complaints (SRC; time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, sleep disorders frequency; total score = maximum 11 points) and parent’s treatment satisfaction. Safety parameters were the incidence of adverse drug reactions (ADRs) and the tolerability of the treatments.

Results The SRC total score decreased from baseline median 7.0 points in both groups to 2.0 points in the intervention group (n=89 children) and 4.0 points in the control group (n=90 children) after 28 days of treatment. Children of the intervention group had overall significant higher odds of getting lower SRC total score (odds ratio: 4.45 (95%-CI: 2.77–7.14), p<0.0001; ITT). First clinical differences between both groups were seen already after 14 days. At day 28 significantly more children in the intervention group showed absence of individual complaints (Chi²-test: all P values≤0.0475; ITT). More parents were either ‘very satisfied’ (n=33) or ‘satisfied’ (n=49) with ZinCyp-3–02 treatment compared to the number of parents with ‘very satisfied’ (n=10) and ‘satisfied’ (n=28) ratings in the control group. Only few ADRs occurred (ZinCyp-3–02: n=2 (nervousness, excitability); control: n=1 (excitement)) and almost all parents and physician (>93% out of 179) rated the tolerability of both treatments as ‘very good’ or ‘good’.

Conclusions ZinCyp-3–02 showed to be a safe and effective treatment option for paediatric sleep disorders and restlessness.