Melatonin, 3 mg, is effective for migraine prevention also in school-aged patients

Hypothalamic dysfunction may be present in migraine and in circadian periodicity of headache attacks, more specifically, the suprachiasmatic nucleus and melatonin have been suggested to play a role in the pathogenesis [1]. Altered melatonin levels have been found in cluster headache, migraine with and without aura, menstrual migraine, and chronic migraine. Melatonin may have many metabolic effects, such as anti-inflammatory effects (melatonin and indomethacin share similar chemical structure), reducing the up-regulation of proinflammatory cytokines, and inhibiting nitric oxide synthase activity and dopamine release. Melatonin administration is thus a possible candidate for migraine prevention [2]. Objective The aim of this open trial was to test the hypothesis of the potential effectiveness of melatonin for migraine prophylaxis also in school-aged children. Patients and methods We performed an open-label trial of melatonin, 3 mg, for migraine prevention. Twenty-three patients (11 M, 12 F) aged 6–15 years (mean 12.8 years, SD±1.38) with episodic migraine with or without aura according to ICHD-II 2004 criteria, were screened for the baseline period. All patients started prophylactic treatment with melatonin, 3 mg, 10 minutes before bedtime for 3 months. A complete clinical interview and examination as well neurophysiological recordings (wake and sleep EEG) were performed for each patient. Study participants experienced between two and six attacks per month. Exclusion criteria included the presence of sleep disorders, as confirmed by the mothers of all subjects who filled out the Sleep Disturbances Scale for Children [SDSC]. The SDSC is a sleep questionnaire that consists of 26 items subdivided into 6 sleep disorder subscales according to American Sleep Disorders Association criteria: DIMS (disorders in initiating and maintaining sleep), SDB (sleep disordered breathing), DA (disorders of arousal), SWTD (sleep-wake transition disorders), DES (disorders of excessive somnolence), SHY (sleep hyperhydrosis). Results Twenty out of 23 patients completed the study (86.95%). That patients (85%, 17/20) who completed the study had at least a 50% reduction in intensity and frequency of headache attacks. Nobody reported an increase in headache frequency. Complete (100%) response was achieved in 12 patients (60%) and no adverse effects were recorded. Conclusions There is increasing evidence to indicate that the hypothalamus plays a major role in the pathophysiology of several of the primary headache disorders, such as migraine, and hypnic headache [1, 2]. Melatonin, an indole compound derived from serotonin, was reported safe and effective in adult patients [2], but no data were available for school-aged children. This is an original study to assess melatonin, 3 mg, for prophylactic treatment of headache also in childhood.