Hancock 2005.

Methods	Randomized, double‐blind, cross‐over, controlled trial
Participants	Inclusion criteria: confirmed diagnosis of tuberous sclerosis complex and sleep problems (Quine Sleep Index score of ≥ 6 out of a possible 8) Exclusion criteria: situational sleep disorder (a higher Quine score at home with a score of < 6 elsewhere) N: 8 (1 lost to follow‐up) M: 4; F: 3 Age: 18 months to 31 years (median age 9 years) All participants had epilepsy and on concurrent AEDs; 2 participants were well controlled All had mental retardation and behavioural difficulties Duration of the trial (including follow‐up): 6 weeks
Interventions	Melatonin 5 mg vs. melatonin 10 mg (see text for more details)
Outcomes	Seizure frequency: 4 participants had seizures during the trial, without change in the frequency (or type) of seizures compared with the baseline period before melatonin treatment at either dose Seizure freedom: 3 participants with well‐controlled epilepsy remained seizure‐free during the trial Adverse events: none reported
Notes	Seizure type was not reported Concurrent AEDs not reported Seizure diaries were used to monitor the frequency and type of seizures Reasons for lost to follow‐up (1 participant) reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Allocation made by the pharmacy using random number sequences
Allocation concealment (selection bias)	Low risk	Participants received identical capsules
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Blinding not explicitly reported (insufficient information to permit judgement)
Incomplete outcome data (attrition bias) All outcomes	Low risk	No lost to follow‐up
Selective reporting (reporting bias)	Low risk	All data regarding outcomes of interest for this systematic review reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding not explicitly reported (insufficient information to permit judgement)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding not explicitly reported (insufficient information to permit judgement)