mark@markwwilsonmdpc.com

assistant@markwwilsonmdpc.com

(917) 441-2344

PayPal can be used to send payment for services:

©2018 by Mark W. Wilson, MD, PC. Proudly created with Wix.com

Long-Term Efficacy and Safety of Melatonin for Insomnia in Children with Autism Spectrum Disorder

September 6, 2018

OBJECTIVE: A recent double-blind randomized placebo-controlled study demonstrated 3-month efficacy and safety of a novel pediatric-appropriate prolonged-release melatonin (PedPRM) for insomnia in children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) with/without attention-deficit/hyperactivity disorder comorbidity. Long-term efficacy and safety of PedPRM treatment was studied.

 

METHODS: A prospective, open-label efficacy and safety follow-up of nightly 2, 5, or 10 mg PedPRM in subjects who completed the 13-week double-blind trial (51 PedPRM; 44 placebo). Measures included caregiver-reported Sleep and Nap Diary, Composite Sleep Disturbance Index (CSDI), caregiver's Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, and quality of life (WHO-5 Well-Being Index).

 

RESULTS: Ninety-five subjects (74.7% males; mean [standard deviation] age, 9 [4.24]; range, 2-17.5 years) received PedPRM (2/5 mg) according to the double-blind phase dose, for 39 weeks with optional dose adjustment (2, 5, or 10 mg/day) after the first 13 weeks. After 52 weeks of continuous treatment (PedPRM-randomized group) subjects slept (mean [SE]) 62.08 (21.5) minutes longer (p = 0.007); fell asleep 48.6 (10.2) minutes faster (p < 0.001); had 89.1 (25.5) minutes longer uninterrupted sleep episodes (p = 0.001); 0.41 (0.12) less nightly awakenings (>50% decrease; p = 0.001); and better sleep quality (p < 0.001) compared with baseline. The placebo-randomized group also improved with PedPRM. Altogether, by the end of 39-week follow-up, regardless of randomization assignment, 55/72 (76%) of completers achieved overall improvement of ≥1 hour in total sleep time (TST), sleep latency or both, over baseline, with no evidence of decreased efficacy. In parallel, CSDI child sleep disturbance and caregivers' satisfaction of their child's sleep patterns (p < 0.001 for both), PSQI global (p < 0.001), and WHO-5 (p = 0.001) improved in statistically significant and clinically relevant manner (n = 72) compared with baseline. PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients).

 

CONCLUSION: PedPRM, an easily swallowed formulation shown to be efficacious versus placebo, is an efficacious and safe option for long-term treatment (up to 52 weeks reported here) of children with ASD and NGD who suffer from insomnia and subsequently improves caregivers' quality of life.

 


Athanasios Maras, Carmen M Schroder, Beth A Malow, Robert L Findling, John Breddy, Tali Nir, Shiri Shahmoon, Nava Zisapel, Paul Gringras.  Journal of Child and Adolescent Psychopharmacology 2018 August 22

Please reload

Our Recent Posts

Below is an updated consent for telehealth; you can obtain the official form from my assistant Eric Scott Kincaid.  I added in the following (listed a...

Updated Consent for Telehealth

March 24, 2020

Hi everyone,

I know you’re all closely watching the new developments in the COVID-19 pandemic and I imagine you’ve seen the recent guidelines that sugg...

COVID-19/coronavirus update

March 15, 2020

For those folks taking lamotrigine (Lamictal), if your generic brand is Taro Pharmaceuticals, there is a recall (due to inactive ingredients that may...

Recall of specific generic brand of lamotrigine (Lamictal)

January 26, 2020

1/1
Please reload

Tags

I'm busy working on my blog posts. Watch this space!

Please reload