Table 2

Summarising the available studies with oral alimemazine in children

CitationStudy groupStudy typeInvestigational productComparatorPrimary outcomeKey result
France et al1645 patients (age 7–27 months) with sleep problemsDouble-blind, randomised controlled trialAlimemazine+extinction*Extinction alone or extinction–plus-placeboDaily sleep diary (duration and time)Abrupt reduction in sleep disturbance with alimemazine
France et al1712 patients (age 6–27 months) with sleep problemsDouble-blind, randomised controlled trialAlimemazine, two different dosesPlaceboDaily sleep diary (duration and time)No clinically significant effects of the low dose detected, whereas the effects of the high dose were not consistently replicated across nor within patients
Richman1822 patients with severe awaking problems (mean age 22 months)Double-blind, randomised controlled trialAlimemazinePlaceboSleep questionnaires: composite scoreModerate improvement, no permanent effect on sleep
Simonoff and Stores1918 patients (age 7–37 months) with night wakingDouble-blind, randomised controlled trialAlimemazinePlaceboParental sleep diary (duration and time)Significantly fewer awakenings, less awake at night and more night-time sleep
Patel et al2190 patients (age 2–12 years) scheduled for anaesthesiaDouble-blind, randomised controlled trialMidazolamDiazepam-droperidol and alimemazineAnxiolysis on arrival in the anaesthetic roomAnxiolysis was significantly greater in the midazolam group compared with the alimemazine group
Mitchell et al2085 children scheduled to undergo anaesthesia for adenoidectomy and/or tonsillectomy, older than 6 monthsDouble-blind, randomised controlled trialMidazolamAlimemazine and placeboAnxiety, crying and distress on arrival in the anaesthetic roomMore patients were calm and quiet following midazolam than following alimemazine, with both premedicant agents comparing favourably with placebo
Antao et al2212 patients (age 8 months–15 years) with retching after Nissen fundoplicationDouble-blind, randomised controlled trialOral alimemazinePlaceboNumber of retching episodesSignificant decrease in the number of retching episodes with alimemazine compared with placebo
  • *Behavioural extinction by withdrawal of parental attention.