Ashkenasi 2011.

Methods	A single‐centre, open‐label, randomised cross‐over study of transdermal methylphenidate effect on sleep disturbance, where participants were randomised to 1 of 4 groups with different sequences of patch wear time (9,10,11,12 hours a day) Phases: Titration period to optimal dose RCT for 4 weeks with a different sequence of patch wear time
Participants	Number of participants screened: not stated Number of participants included: 26 Number of participants followed up: 24 Number of withdrawals: 2 Diagnosis of ADHD: DSM‐IV (subtype: combined (77%)) Age: mean 9.3 years, range 6‐12 years old IQ: > 70 Sex: 19 males, 7 females Methylphenidate‐naïve: not stated Ethnicity: not stated Comorbidity: sleep disturbances Comedication: none Sociodemographics: not stated Inclusion criteria: Children aged 6‐12 years Met the DSM‐IV criteria for attention deficit hyperactivity disorder (any subtype) Demonstrated difficulty sleeping (as reported by the caregiver) Exclusion criteria: Patients with previous intolerance, adverse response, or allergy to methylphenidate or skin sensitivity to the methylphenidate transdermal system Severe comorbid psychiatric disorders (e.g. psychosis, bipolar illness, pervasive developmental disorders, severe obsessive compulsive disorder, severe depression, or severe anxiety disorder) or other symptomatic manifestations that would, in the opinion of the examining physician, contraindicate the use of methylphenidate or confound efficacy or safety assessments (i.e., common, less severe comorbidities of attention deficit hyperactivity disorder were permitted) A history of seizure disorder, tics/Tourette syndrome, known structural cardiac abnormalities, hypertension, hyperthyroidism, glaucoma, and pregnancy/lactation Use of psychotropic medications (other than study medications) and medications that might affect sleep (e.g. antihistamines or decongestants)
Interventions	Participants were randomly assigned to different drug condition orders Methylphenidate type: methylphenidate transdermal system Mean methylphenidate dosage: 20 mg Administration schedule: once daily in the morning, switching between 9, 10, 11 and 12 hour alternating wear time across 4 consecutive weeks. Patch wear times were maintained Monday through Thursday of each week. Patients followed the standard 9‐hour wear time schedule on weekends (i.e. Friday through Sunday) Duration of intervention: 4 weeks Washout before study initiation: 1 week before titration period to optimal dose. And a minimum of 12 hours between 2 consecutive days during the trial Titration period: before randomisation Treatment compliance: 1 participant discontinued because of non‐compliance. No information about the others
Outcomes	Serious adverse events: Hallucinosis: 1 child "withdrew after completing the randomization phase because of a significant medication side effect that emerged later in the study (i.e., hallucinosis)". No hospitalisation, symptoms withdrew after medication was discontinued Non‐serious adverse events: Skin reactions were coded on a 3‐point scale, where 0 ¼ no change, 1 ¼ slight pink/pink, and 2 ¼ slight red/ red. Rated by caregivers Sleep was assessed according to a daily sleep diary, with entries for time of patch application and removal, sleep timing (e.g. bedtime, time to fall asleep, number of awakenings, time awake at night, and final wake time), and ratings of sleep quality (on a 5‐point scale). Entries were recorded at baseline, after determination of the optimal patch dose, daily during wear time titration, and at endpoint. The sleep diary was documented by caregivers Monday through Sunday of every week throughout the wear time titration
Notes	Funding: investigator‐sponsored grants from Shire Pharmaceuticals, Inc. and Noven Pharmaceuticals, Inc. Vested interest/authors' affiliations: Shire Pharmaceuticals, Noven Pharmaceuticals. "..these companies were not involved in the conduct of the study or the preparation of the manuscript" Key conclusions of the study authors: patch wear time exerted no significant effect on sleep latency or total sleep time, although a trend toward improved sleep quality was evident (P ¼ 0.059) with longer patch wear times. Sleep parameters were not adversely affected by longer methylphenidate transdermal system patch wear times Comments from the study authors: limitations of the study: small sample size, for instance resulting in a weaker randomisation to patch wear time sequence that was not completely effective in balancing baseline covariates Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes. Children with previous intolerance or adverse events on methylphenidate were excluded Supplemental information received through personal email correspondence with the authors in September 2013. Not possible to get the necessary supplemental information on non‐serious adverse events (Ashkenasi 2013 [pers comm])