Sleep problems (SP) are recognized as a common comorbid condition in autism spectrum disorder (ASD) and can influence core autism symptoms and mental and physical health. SPs can be lifelong and have been reported that adults on the autistic spectrum with and without intellectual disability (ID) present SPs (longer sleep latency, frequent night awakenings, and circadian rhythm sleep-wake disorders). A prospective, objective sleep study was conducted in 41 adults with ASD (33 AE 6 years old) and ID and 51 typically developing adults (33 AE 5 years old) using ambulatory circadian monitoring (ACM) recording wrist temperature, motor activity, body position, sleep, and light intensity. The findings indicated that individuals with ASD presented sleep difficulties including low sleep efficiency, prolonged sleep latency and increased number and length of night awakenings, together with daily sedentary behavior, and increased nocturnal activity. Furthermore, indications of an advanced sleepwake phase disorder were found in these autistic adults. Examining sleep and markers of the circadian system showed significant differences between adults with ASD and ID and an age-matched, healthy adult population. The sleep disturbances described for this sample of adults with ASD and ID are similar to those of already described for adults with ASD without ID; their relationship with intellectual ability should be further studied. Improving knowledge of sleep patterns in ASD adults with ID might help to designed targeted interventions to improve their functioning and reduce family stress. Autism Research 2019, 12: 66-79.Lay Summary: SPs are very frequent in autism from childhood to adulthood. We recorded sleep with a watch-like device in adults with autism and ID and compared sleep patterns with nonautistic volunteers. Results showed poorer sleep conditions in adults with autism (increased sleep latency and number/length of night awakenings) that resulted in decreased sleep efficiency. Increasing knowledge of the SPs in adults on the autism spectrum will allow to improve their and their families' quality of life.

Purpose: Intellectual disability (ID) and autism spectrum disorder (ASD) are common, co-occurring developmental disorders and are frequently associated with sleep problems. This study aimed to assess the effectiveness and tolerability of agomelatine as a pharmacotherapy for sleep problems in ASD adults with ID. Method: A randomised, crossover, triple-blind, placebo-controlled clinical trial, with two three-month periods of treatment starting with either agomelatine or placebo and a washout period of two weeks. Ambulatory circadian monitoring (24 hours/7 days) evaluated total sleep time (TST) as the primary outcome variable. Results: Participants ( N=23; 35±12 years old; 83% male) had a median of three (interquartile range (IQR) 1–4) co-morbidities and were taking a median of five (IQR 2–7) prescribed drugs. Before agomelatine or placebo treatment, all subjects presented with insomnia symptoms, including sleep latency (100% abnormal, 55±23 minutes) or TST (55% abnormal, 449±177 minutes), and 66% had circadian rhythm sleep–wake abnormalities with rhythm phase advancements according to the M5 sleep phase marker values. During the three-month agomelatine treatment, night TST significantly increased by a mean of 83 minutes (16% abnormal, 532±121 minutes), together with a phase correction (M5 1:45±2:28 hours vs. 3:15±2:20 hours), improving sleep stability in wrist temperature rhythm (0.43±0.29 vs. 0.52±0.18 AU). Adverse events were mild and transient. Conclusions: Agomelatine was effective and well tolerated for treating insomnia and circadian rhythm sleep problems present in adults with ASD and ID.

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The internal systems for quality assure are being introduced in the health care environment, and especially in hospitals. The Clinical Pharmacology Service (CPS) at a University Hospital has implemented a quality management system, consistently with ISO 9001:2008 requirements and subjected to external audits by AENOR. The CPS defined 6 processes representing its activity in the hospital, and within each of those processes defined a number of indicators of the performance and its quality (process/n indicators): Clinical consultations (6), Safety of medicines and pharmacovigilance (7), Therapeutic Drug Monitoring (3), Policy and medicines selection (5), Clinical trials (4) and Clinical research (2). Three of the indicators were satisfaction surveys. The implantation period lasted 10 months. In a first phase (4 months), the design and documentation of the processes were developed; 24 procedures, 9 work instructions and 67 forms (or records) were documented and incorporated into the management system. In a second phase (6 months) the system was implemented. The internal and the external audits valued the performance and gave the higher standards to the CPS. The certification improved the activity of the CPS by using a structured process, analyzing the results, and introducing improvements. Furthermore the activity of the CPS was clearly visible for the rest of the Hospital and especially for the head physician team. The extra bureaucratic work pays off for the results obtained.