Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder
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OBJECTIVE: To assess the efficacy and safety of novel pediatric-appropriate, prolonged-release melatonin minitablets (PedPRM) versus placebo for insomnia in children and adolescents with autism spectrum disorder (ASD), with or without attention-deficit/hyperactivity disorder (ADHD) comorbidity, and neurogenetic disorders (NGD). METHOD: A total of 125 children and adolescents (2-17.5 years of age; 96.8% ASD, 3.2% Smith-Magenis syndrome [SMS]) whose sleep failed to improve on behavioral intervention alone were randomized (1:1 ratio), double-blind, to receive PedPRM (2 mg escalated to 5 mg) or placebo for 13 weeks. Sleep measures included the validated caregivers' Sleep and Nap Diary (SND) and Composite Sleep Disturbance Index (CSDI). The a priori primary endpoint was SND-reported total sleep time (TST) after 13 weeks of treatment. RESULTS: The study met the primary endpoint: after 13 weeks of double-blind treatment, participants slept on average 57.5 minutes longer at night with PedPRM compared to 9.14 minutes with placebo (adjusted mean treatment difference PedPRM-placebo -32.43 minutes; p = .034). Sleep latency (SL) decreased by 39.6 minutes on average with PedPRM and 12.5 minutes with placebo (adjusted mean treatment difference -25.30 minutes; p = .011) without causing earlier wakeup time. The rate of participants attaining clinically meaningful responses in TST and/or SL was significantly higher with PedPRM than with placebo (68.9% versus 39.3% respectively; p = .001) corresponding to a number needed to treat (NNT) of 3.38. Overall sleep disturbance (CSDI) tended to decrease. PedPRM was generally safe; somnolence was more commonly reported with PedPRM than placebo. CONCLUSION: PedPRM was efficacious and safe for treatment of insomnia in children and adolescents with ASD with/without ADHD and NGD. The acceptability of this pediatric formulation in a population who usually experience significant difficulties in swallowing was remarkably high. Clinical trial registration information-Efficacy and Safety of Circadin in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities; http://clinicaltrials.gov/; NCT01906866.
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There is increasing evidence for the use of prolonged-release melatonin in autistic individuals with limited response to regular release formulations.
“There is increasing evidence for the use of prolonged-release melatonin in autistic individuals with limited response to regular release formulations [60].”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [60]
Cites
Diagnostic and Statistical Manual of Mental Disorders(DSM)
Leong, F. T. L. (2008) · Sage eBooks · doi:10.4135/9781412963978.n182 · Cited by 10,858 · see citing works
Cohen, J. (1992) · Psychological Bulletin · doi:10.1037//0033-2909.112.1.155 · Cited by 8,771 · see citing works
The consensus sleep diary: standardizing prospective sleep self-monitoring
Carney, C. E., Buysse, D. J., Ancoli-Israel, S., Edinger, J. D., Krystal, A. D., Lichstein, K. L., & Morin, C. M. (2012) · Sleep · doi:10.5665/sleep.1642 · Cited by 2,172 · see citing works
Melatonin in autism spectrum disorders: a systematic review and meta-analysis
ROSSIGNOL, D. A., & FRYE, R. E. (2011) · Developmental Medicine & Child Neurology · doi:10.1111/j.1469-8749.2011.03980.x · Cited by 468 · see citing works
Nocturnal excretion of 6-sulphatoxymelatonin in children and adolescents with autistic disorder
Tordjman, S., Anderson, G. M., Pichard, N., Charbuy, H., & Touitou, Y. (2005) · Biological Psychiatry · doi:10.1016/j.biopsych.2004.11.003 · Cited by 296 · see citing works
Malow, B. A., Byars, K. C., Johnson, K., Weiss, S. K., Bernal, P., Goldman, S. E., Panzer, R., Coury, D. L., & Glaze, D. G. (2012) · PEDIATRICS · doi:10.1542/peds.2012-0900i · Cited by 277 · see citing works
Cortesi, F., Giannotti, F., Sebastiani, T., Panunzi, S., & Valente, D. (2012) · Journal of Sleep Research · doi:10.1111/j.1365-2869.2012.01021.x · Cited by 275 · see citing works
Malow, B., Adkins, K. W., McGrew, S. G., Wang, L., Goldman, S. E., Fawkes, D., & Burnette, C. (2012) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-011-1418-3 · Cited by 274 · see citing works
Erland, L. A. E., & Saxena, P. K. (2017) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.6462 · Cited by 273 · see citing works
Sleep in Children With Autism Spectrum Disorder
Kotagal, S., & Broomall, E. M. (2012) · Pediatric Neurology · doi:10.1016/j.pediatrneurol.2012.05.007 · Cited by 271 · see citing works
Pharmacologic Management of Insomnia in Children and Adolescents: Consensus Statement
Mindell, J. A. A., Emslie, G. J., Blumer, J. L., Genel, M., Glaze, D. G., Ivanenko, A., Johnson, K., ROSEN, C. L., Steinberg, F. J., Roth, T. G., et al. (2006) · PEDIATRICS · doi:10.1542/peds.2005-1693 · Cited by 247 · see citing works
Arendt, J. (1988) · Clinical Endocrinology · doi:10.1111/j.1365-2265.1988.tb00263.x · Cited by 227 · see citing works
Gringras, P., Gamble, C. L., Jones, A. P., Wiggs, L. D., Williamson, P. R., Sutcliffe, A. G., Montgomery, P., Whitehouse, W. P., Choonara, I., Allport, T., et al. (2012) · BMJ · doi:10.1136/bmj.e6664 · Cited by 218 · see citing works
Self-citationMinitablets: New Modality to Deliver Medicines to Preschool-Aged Children
Thomson, S. A., Tuleu, C., Wong, I. C. K., Keady, S., Pitt, K. G., & Sutcliffe, A. G. (2009) · PEDIATRICS · doi:10.1542/peds.2008-2059 · Cited by 192 · see citing works
Elrod, M. G., & Hood, B. S. (2015) · Journal of Developmental & Behavioral Pediatrics · doi:10.1097/dbp.0000000000000140 · Cited by 191 · see citing works
Cuomo, B., Vaz, S. M. A., Lee, E. A. L., Thompson, C., Rogerson, J. M., & Falkmer, T. (2017) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.1920 · Cited by 170 · see citing works
Sleep problems of children with pervasive developmental disorders: correlation with parental stress
Doo, S., & Wing, Y. K. (2006) · Developmental Medicine & Child Neurology · doi:10.1017/s001216220600137x · Cited by 145 · see citing works
Wade, A. G., Crawford, G. M., Ford, I., McConnachie, A., Nir, T., Laudon, M., & Zisapel, N. (2010) · Current Medical Research and Opinion · doi:10.1185/03007995.2010.537317 · Cited by 126 · see citing works
Self-citationHollway, J. A., & Aman, M. G. (2011) · Research in Developmental Disabilities · doi:10.1016/j.ridd.2010.12.035 · Cited by 115 · see citing works
Autism spectrum features in Smith–Magenis syndrome
Laje, G., Morse, R., Richter, W., Ball, J., Pao, M., & Smith, A. C. M. (2010) · American Journal of Medical Genetics Part C: Seminars in Medical Genetics · doi:10.1002/ajmg.c.30275 · Cited by 108 · see citing works
Sleep problems of children with pervasive developmental disorders: correlation with parental stress
MRCPCH, S. D., & Wing, Y. K. (2007) · Developmental Medicine & Child Neurology · doi:10.1111/j.1469-8749.2006.tb01334.x · Cited by 107 · see citing works
Montgomery, P. (2004) · Archives of Disease in Childhood · doi:10.1136/adc.2002.017202 · Cited by 100 · see citing works
Inverted rhythm of melatonin secretion in Smith–Magenis syndrome: from symptoms to treatment
Leersnyder, H. D. (2006) · Trends in Endocrinology and Metabolism · doi:10.1016/j.tem.2006.07.007 · Cited by 98 · see citing works
Appleton, R., Jones, A. P., Gamble, C. L., Williamson, P. R., Wiggs, L. D., Montgomery, P., Sutcliffe, A. G., Barker, C. E., & Gringras, P. (2012) · Health Technology Assessment · doi:10.3310/hta16400 · Cited by 96 · see citing works
Self-citationLoss of response to melatonin treatment is associated with slow melatonin metabolism
Braam, W., Van Geijlswijk, I., Keijzer, H., Smits, M. G., Didden, R., & Curfs, L. M. G. (2010) · Journal of Intellectual Disability Research · doi:10.1111/j.1365-2788.2010.01283.x · Cited by 94 · see citing works
Prolonged-Release Melatonin for Children With Neurodevelopmental Disorders
Leersnyder, H. D., Zisapel, N., & Laudon, M. (2011) · Pediatric Neurology · doi:10.1016/j.pediatrneurol.2011.02.001 · Cited by 69 · see citing works
Zopiclone improves sleep quality and daytime well-being in insomniac patients
Hajak, G., Clarenbach, P., Fischer, W., Haase, W., & Rüther, E. (1994) · International Clinical Psychopharmacology · doi:10.1097/00004850-199400940-00004 · Cited by 51 · see citing works
Chua, H., Richer, N. H., Swedrowska, M., Ingham, S., Tomlin, S., & Forbes, B. (2016) · Pharmaceutics · doi:10.3390/pharmaceutics8010002 · Cited by 35 · see citing works
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Hirota, T., & King, B. H. (2023) · JAMA · doi:10.1001/jama.2022.23661 · Cited by 957 · see citing works
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Zisapel, N. (2018) · British Journal of Pharmacology · doi:10.1111/bph.14116 · Cited by 893 · see citing works
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Logan, R. W., & McClung, C. A. (2019) · Nature Reviews Neuroscience · doi:10.1038/s41583-018-0088-y · Cited by 713 · see citing works
Melatonin as a Hormone: New Physiological and Clinical Insights
Cipolla‐Neto, J., & do Amaral, F. G. (2018) · Endocrine Reviews · doi:10.1210/er.2018-00084 · Cited by 653 · see citing works
Wilson, S., Anderson, K., Baldwin, D., Dijk, D.-J., Espie, A., Espie, C., Gringras, P., Krystal, A., Nutt, D., Selsick, H., et al. (2019) · Journal of Psychopharmacology · doi:10.1177/0269881119855343 · Cited by 312 · see citing works
Self-citationMelatonin: A Versatile Protector against Oxidative DNA Damage
Galano, A., Tan, D., & Reiter, R. J. (2018) · Molecules · doi:10.3390/molecules23030530 · Cited by 290 · see citing works
Signalling pathways in autism spectrum disorder: mechanisms and therapeutic implications
Jiang, C.-C., Lin, L., Long, S., Ke, X., Fukunaga, K., Lu, Y., & Han, F. (2022) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-022-01081-0 · Cited by 272 · see citing works
Williams Buckley, A., Hirtz, D., Oskoui, M., Armstrong, M. J., Batra, A., Bridgemohan, C., Coury, D., Dawson, G., Donley, D., Findling, R. L., et al. (2020) · Neurology · doi:10.1212/wnl.0000000000009033 · Cited by 228 · see citing works
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Aishworiya, R., Valica, T., Hagerman, R., & Restrepo, B. (2022) · Neurotherapeutics · doi:10.1007/s13311-022-01183-1 · Cited by 233 · see citing works
An update on pharmacotherapy for autism spectrum disorder in children and adolescents
Ji, N. Y., & Findling, R. L. (2015) · Current Opinion in Psychiatry · doi:10.1097/yco.0000000000000132 · Cited by 217 · see citing works
Self-citationCarmassi, C., Palagini, L., Caruso, D., Masci, I., Nobili, L., Vita, A., & Dell’Osso, L. (2019) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2019.00366 · Cited by 220 · see citing works
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Ferlazzo, N., Andolina, G., Cannata, A., Costanzo, M. G., Rizzo, V., Currò, M., Ientile, R., & Caccamo, D. (2020) · Antioxidants · doi:10.3390/antiox9111088 · Cited by 189 · see citing works
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Self-citationAbdelgadir, I. S., Gordon, M. A., & Akobeng, A. K. (2018) · Archives of Disease in Childhood · doi:10.1136/archdischild-2017-314181 · Cited by 117 · see citing works
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Neves, A. R., Albuquerque, T., Quintela, T., & Costa, D. R. B. (2022) · Journal of Cellular Physiology · doi:10.1002/jcp.30815 · Cited by 120 · see citing works
Cortese, S., Wang, F., Angriman, M., Masi, G., & Bruni, O. (2020) · CNS Drugs · doi:10.1007/s40263-020-00710-y · Cited by 101 · see citing works
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Victor, S., Rocha‐Ferreira, E., Rahim, A. A., Hagberg, H., & Edwards, A. D. (2021) · European Journal of Pediatrics · doi:10.1007/s00431-021-04320-8 · Cited by 101 · see citing works
Melatonin: From Pharmacokinetics to Clinical Use in Autism Spectrum Disorder
Lalanne, S., Fougerou-Leurent, C., Anderson, G. M., Schroder, C. M., Nir, T., Chokron, S., Delorme, R., Claustrat, B., Bellissant, E., Kermarrec, S., et al. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22031490 · Cited by 90 · see citing works
Self-citationPalagini, L., Manni, R., Aguglia, E., Amore, M., Brugnoli, R., Bioulac, S., Bourgin, P., Micoulaud‐Franchi, J., Girardi, P., Grassi, L. G., et al. (2021) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2021.688890 · Cited by 93 · see citing works
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Johnson, K., & Zarrinnegar, P. (2020) · Child and Adolescent Psychiatric Clinics of North America · doi:10.1016/j.chc.2020.08.012 · Cited by 87 · see citing works
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Arendt, J. (2019) · Frontiers in Endocrinology · doi:10.3389/fendo.2019.00391 · Cited by 89 · see citing works
Reiter, R. J., Sharma, R., Ma, Q., Rosales‐Corral, S., & Chuffa, L. G. D. A. (2020) · Cellular and Molecular Life Sciences · doi:10.1007/s00018-019-03438-1 · Cited by 79 · see citing works
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Ballester, P., Richdale, A. L., Baker, E. K., & Peiró, A. M. (2020) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2020.101357 · Cited by 81 · see citing works
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Dijk, D., & Landolt, H. (2019) · Handbook of experimental pharmacology · doi:10.1007/164_2019_243 · Cited by 71 · see citing works
Baglioni, C., Bostanova, Z., Bacaro, V., Benz, F., Hertenstein, E., Spiegelhalder, K., Rücker, G., Frase, L., Riemann, D. W., & Feige, B. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9061949 · Cited by 71 · see citing works
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Cameron, S., Donnelly, A., Broderick, C., Arichi, T., Bartsch, U., Dazzan, P., Elberling, J., Godfrey, E. L., Gringras, P., Heathcote, L. C., et al. (2023) · Allergy · doi:10.1111/all.15818 · Cited by 72 · see citing works
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Geoffroy, P. A., Micoulaud‐Franchi, J., Lopez, R., & Schroder, C. M. (2019) · L Encéphale · doi:10.1016/j.encep.2019.04.068 · Cited by 64 · see citing works
Moon, E., Kim, K., Partonen, T., & Mantere, O. (2022) · Current Psychiatry Reports · doi:10.1007/s11920-022-01369-6 · Cited by 61 · see citing works
Barlow, K. M., Esser, M. J., Veidt, M., & Boyd, R. N. (2018) · Journal of Neurotrauma · doi:10.1089/neu.2018.5752 · Cited by 59 · see citing works
Chronic Administration of Melatonin: Physiological and Clinical Considerations
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Pharmacologic Treatments for Sleep Disorders in Children: A Systematic Review
McDonagh, M. S., Holmes, R. S., & Hsu, F. C. (2019) · Journal of Child Neurology · doi:10.1177/0883073818821030 · Cited by 59 · see citing works
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Comorbidities and quality of life in children with intellectual disability
Reddihough, D. S., Leonard, H., Jacoby, P. A., Kim, R., Epstein, A., Murphy, N., Reid, S., Whitehouse, A., Williams, K. J., & Downs, J. A. (2021) · Child Care Health and Development · doi:10.1111/cch.12873 · Cited by 58 · see citing works
Esposito, D., Belli, A., Ferri, R., & Bruni, O. (2020) · Brain Science · doi:10.3390/brainsci10070441 · Cited by 49 · see citing works
Lamy, M., & Erickson, C. A. (2018) · Current problems in pediatric and adolescent health care · doi:10.1016/j.cppeds.2018.08.015 · Cited by 58 · see citing works
Rzepka-Migut, B., & Paprocka, J. (2020) · Brain Sciences · doi:10.3390/brainsci10040219 · Cited by 55 · see citing works
The Relationship between Autism Spectrum Disorder and Melatonin during Fetal Development
Jin, Y., Choi, J., Won, J., & Hong, Y. (2018) · Molecules · doi:10.3390/molecules23010198 · Cited by 52 · see citing works
Yuge, K., Nagamitsu, S., Ishikawa, Y., Hamada, I., Takahashi, H., Sugioka, H., Yotsuya, O., Mishima, K., Hayashi, M., & Yamashita, Y. (2020) · BMC Psychiatry · doi:10.1186/s12888-020-02847-y · Cited by 57 · see citing works
The psychopharmacology of autism spectrum disorder and Rett syndrome
Persico, A. M., Ricciardello, A., & Cucinotta, F. (2019) · Handbook of clinical neurology · doi:10.1016/b978-0-444-64012-3.00024-1 · Cited by 53 · see citing works
Salanitro, M., Wrigley, T., Ghabra, H., de Haan, E. H. F., Hill, C. M., Solmi, M., & Cortese, S. (2022) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2022.104723 · Cited by 48 · see citing works
Yavuz-Kodat, E., Reynaud, È., Geoffray, M., Limousin, N., Franco, P., Bonnet‐Brilhault, F., Bourgin, P., & Schroder, C. M. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9061978 · Cited by 47 · see citing works
Skrzelowski, M., Brookhaus, A., Shea, L. A., & Berlau, D. J. (2021) · The Journal of Pediatric Pharmacology and Therapeutics · doi:10.5863/1551-6776-26.1.4 · Cited by 46 · see citing works
Schroder, C. M., Banaschewski, T., Fuentes, J., Hill, C. M., Hvolby, A., Posserud, M.-B. R., & Bruni, O. (2021) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2021.1959549 · Cited by 44 · see citing works
Händel, M. N., Andersen, H., Ussing, A., Virring, A., Jennum, P., Debes, N. M., Laursen, T., Baandrup, L., Gade, C., Nielsen, J. D., et al. (2023) · EClinicalMedicine · doi:10.1016/j.eclinm.2023.102083 · Cited by 43 · see citing works
Quera-Salva, M.-A., & Claustrat, B. (2018) · L Encéphale · doi:10.1016/j.encep.2018.06.005 · Cited by 43 · see citing works
Dysregulation of Circadian Rhythms in Autism Spectrum Disorders
Pinato, L., Spilla, C. S. G., Markus, R. P., & Cruz‐Machado, S. D. S. (2019) · Current Pharmaceutical Design · doi:10.2174/1381612825666191102170450 · Cited by 43 · see citing works
Pattison, E., Papadopoulos, N. V., Marks, D., McGillivray, J., & Rinehart, N. (2020) · Current Psychiatry Reports · doi:10.1007/s11920-020-01172-1 · Cited by 41 · see citing works
Pediatric use of prescribed melatonin in Sweden 2006–2017: a register based study
Kimland, E. E., Bardage, C., Collin, J., Järleborg, A., Ljung, R., & Iliadou, A. N. (2020) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-020-01598-1 · Cited by 39 · see citing works
Mantle, D., Smits, M. G., Boss, M., Miedema, I., & van Geijlswijk, I. M. (2020) · Sleep Medicine X · doi:10.1016/j.sleepx.2020.100022 · Cited by 41 · see citing works
Barlow, K. M., Kirk, V. G., Brooks, B. L., Esser, M. J., Yeates, K. O., Zemek, R. L., Kirton, A., Mikrogianakis, A., MacMaster, F. P., Nettel‐Aguirre, A., et al. (2020) · Journal of Neurotrauma · doi:10.1089/neu.2020.7154 · Cited by 39 · see citing works
Bertelli, M. O., Azeem, M. W., Underwood, L., Scattoni, M. L., Persico, A. M., Ricciardello, A., Sappok, T., Bergmann, T. J., Keller, R., Bianco, A., et al. (2022) · Springer eBooks · doi:10.1007/978-3-319-95720-3_16 · Cited by 41 · see citing works
Lamy, M., Pedapati, E. V., Dominick, K. C., Wink, L. K., & Erickson, C. A. (2020) · Pediatric Drugs · doi:10.1007/s40272-020-00408-0 · Cited by 36 · see citing works
The relationship between sleep and depression and bipolar disorder in children and young people
Comsa, M., Anderson, K. N., Sharma, A., Yadav, V. C., & Watson, S. (2022) · BJPsych Open · doi:10.1192/bjo.2021.1076 · Cited by 41 · see citing works
Kotagal, S., Malow, B. A., Spruyt, K., Wang, G., Almeida, C. E. B., Tavera-Saldaña, L. M., Blunden, S. L., Narang, I., Ipsiroglu, O., Bruni, O., et al. (2024) · Sleep Medicine · doi:10.1016/j.sleep.2024.04.008 · Cited by 36 · see citing works
The Role of Oxidative Stress in Autism Spectrum Disorder Pathophysiology, Diagnosis and Treatment
Kuźniar-Pałka, A. (2025) · Biomedicines · doi:10.3390/biomedicines13020388 · Cited by 36 · see citing works
Maniram, J., Karrim, S. B., Oosthuizen, F., & Wiafe, E. (2022) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s371013 · Cited by 36 · see citing works
Sleep Problems of Children with Autism May Independently Affect Parental Quality of Life
Liu, R., Dong, H., Wang, Y., Lu, X., Li, Y., Xun, G., Ou, J., Shen, Y., Xia, K., & Zhao, J. (2020) · Child Psychiatry & Human Development · doi:10.1007/s10578-020-01035-z · Cited by 34 · see citing works
Paediatric neurodisability and sleep disorders: clinical pathways and management strategies
McDonald, A., & Joseph, D. (2019) · BMJ Paediatrics Open · doi:10.1136/bmjpo-2018-000290 · Cited by 33 · see citing works
Behavioral insomnia in infants and young children
Kang, E. K., & Kim, S. S. (2020) · Korean Journal of Pediatrics · doi:10.3345/cep.2020.00052 · Cited by 33 · see citing works
Diagnosis and management of sleep disorders in Prader-Willi syndrome
Duis, J. B., Pullen, L. C., Picone, M., Friedman, N. R., Hawkins, S., Sannar, E. M., Pfalzer, A. C., Shelton, A. R., Singh, D., Zee, P. C., et al. (2022) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.9938 · Cited by 33 · see citing works
Singla, R., Mishra, A., & Cao, R. (2022) · Translational Psychiatry · doi:10.1038/s41398-022-02120-8 · Cited by 33 · see citing works
Decades of Progress in the Psychopharmacology of Autism Spectrum Disorder
Henneberry, E. A., Lamy, M., Dominick, K. C., & Erickson, C. A. (2021) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-021-05237-9 · Cited by 31 · see citing works
What do we really know about the safety and efficacy of melatonin for sleep disorders?
Kennaway, D. J. (2021) · Current Medical Research and Opinion · doi:10.1080/03007995.2021.2000714 · Cited by 31 · see citing works
Melatonin Use in Pediatrics: A Clinical Review on Indications, Multisystem Effects, and Toxicity
Shenoy, P., Etcheverry, A., Ia, J., Witmans, M., & Tablizo, M. A. (2024) · Children · doi:10.3390/children11030323 · Cited by 30 · see citing works
Taking Sleep Difficulties Seriously in Children With Neurodevelopmental Disorders and ASD
Lord, C. (2019) · PEDIATRICS · doi:10.1542/peds.2018-2629 · Cited by 30 · see citing works
Ballester, P., Martínez, M. J., Inda, M., Javaloyes, A., Richdale, A., Muriel, J., Belda, C., Toral, N., Morales, D., Fernandez, E., et al. (2019) · Journal of Psychopharmacology · doi:10.1177/0269881119864968 · Cited by 21 · see citing works
The effect of acupuncture on depression and its correlation with metabolic alterations
Li, W., Sun, M., Yin, X., Lao, L., Kuang, Z., & Xu, S. (2020) · Medicine · doi:10.1097/md.0000000000022752 · Cited by 31 · see citing works
Determinants of sleep problems in children with intellectual disability
Gilbertson, M., Richardson, C. E., Eastwood, P. R., Wilson, A. C., Jacoby, P. A., Leonard, H., & Downs, J. A. (2021) · Journal of Sleep Research · doi:10.1111/jsr.13361 · Cited by 29 · see citing works
Autism Spectrum Disorder and Sleep
Johnson, K., & Zarrinnegar, P. (2024) · Psychiatric Clinics of North America · doi:10.1016/j.psc.2023.06.013 · Cited by 29 · see citing works
How did I get so late so soon? A review of time processing and management in autism
Jurek, L., Longuet, Y., Baltazar, M., Amestoy, A., Schmitt, V., Desmurget, M., & Geoffray, M. (2019) · Behavioural Brain Research · doi:10.1016/j.bbr.2019.112121 · Cited by 28 · see citing works
Understanding the role of sleep and its disturbances in Autism spectrum disorder
Ramanujam, K., Cardinali, D. P., Venkat, S., Spence, D. W., Brown, G. M., & Pandi-Perumal, S. R. (2020) · International Journal of Neuroscience · doi:10.1080/00207454.2019.1711377 · Cited by 28 · see citing works
Sleep Problems in Autism Spectrum Disorder.
Sidhu, N., Wong, Z. M., Bennett, A. E., & Souders, M. (2024) · The Pediatric clinics of North America · doi:10.1016/j.pcl.2024.01.006 · Cited by 24 · see citing works
Sleep disturbances in autism spectrum disorder: Animal models, neural mechanisms, and therapeutics
Maurer, J. J., Choi, A., An, I., Sathi, N., & Chung, S. (2023) · Neurobiology of Sleep and Circadian Rhythms · doi:10.1016/j.nbscr.2023.100095 · Cited by 28 · see citing works
Lura, V., Lura, A., Breitkreutz, J., & Klingmann, V. (2025) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2025.114655 · Cited by 25 · see citing works
Seo, W. (2021) · Yeungnam University Journal of Medicine · doi:10.12701/yujm.2021.01410 · Cited by 20 · see citing works
Efficacy of Melatonin for Insomnia in Children with Autism Spectrum Disorder: A Meta-analysis
Xiong, M., Li, F., Liu, Z., Xie, X., Shen, H., Li, W., Wei, L., & He, R. (2023) · Neuropediatrics · doi:10.1055/s-0043-1761437 · Cited by 24 · see citing works
The role of microRNAs in the molecular link between circadian rhythm and autism spectrum disorder
Kim, J. Y., Kim, W., & Lee, K. (2023) · Animal Cells and Systems · doi:10.1080/19768354.2023.2180535 · Cited by 24 · see citing works
Parvataneni, T., Srinivas, S., Shah, K. H., & Patel, R. S. (2020) · Cureus · doi:10.7759/cureus.8335 · Cited by 23 · see citing works
Autism - A Comprehensive Array of Prominent Signs and Symptoms
Nadeem, M. S., Murtaza, B. N., Al-Ghamdi, M. A., Ali, A., Zamzami, M. A., Khan, J. A., Ahmad, A., Rehman, M. U., & Kazmi, I. A. (2021) · Current Pharmaceutical Design · doi:10.2174/1381612827666210120095829 · Cited by 25 · see citing works
Hejduk, A., Czajka, S., & Lulek, J. (2021) · Powder Technology · doi:10.1016/j.powtec.2021.03.063 · Cited by 23 · see citing works
Chronic insomnia of early childhood: Phenotypes and pathophysiology
Bruni, O., DelRosso, L. M., Mogavero, M. P., Angriman, M., & Ferri, R. (2022) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2022.104653 · Cited by 23 · see citing works
Neonatal irritable sleep-wake rhythm as a predictor of autism spectrum disorders
Miike, T., Toyoura, M., Tonooka, S., Konishi, Y., Oniki, K., Saruwatari, J., Tajima, S., Kinoshita, J., Nakai, A., & Kikuchi, K. (2020) · Neurobiology of Sleep and Circadian Rhythms · doi:10.1016/j.nbscr.2020.100053 · Cited by 22 · see citing works
Effects of Supplementation With Antioxidant Agents on Sleep in Autism Spectrum Disorder: A Review
Zambrelli, E., Lividini, A., Spadavecchia, S., Turner, K., & Canevini, M. P. (2021) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2021.689277 · Cited by 21 · see citing works
Tse, A. C. Y., Lee, P. H., Sit, C. H. P., Poon, E. T., Sun, F., Pang, C.-L., & Cheng, J. W. C. H. (2023) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-023-06172-7 · Cited by 21 · see citing works
Adams, J. B., Bhargava, A., Coleman, D. M., Frye, R. E., & Rossignol, D. A. (2021) · Journal of Personalized Medicine · doi:10.3390/jpm11090878 · Cited by 22 · see citing works
Modulation of neural circuits by melatonin in neurodegenerative and neuropsychiatric disorders
Giri, A., Mehan, S., Khan, Z., Gupta, G. D., Narula, A. S., & Kalfin, R. E. (2024) · Naunyn-Schmiedeberg s Archives of Pharmacology · doi:10.1007/s00210-023-02939-y · Cited by 20 · see citing works
Zisapel, N. (2022) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2022.2053520 · Cited by 19 · see citing works
Melatonin Treatment for Pediatric Patients with Insomnia: Is There a Place for It?
Rolling, J., Rabot, J., & Schroder, C. M. (2022) · Nature and Science of Sleep · doi:10.2147/nss.s340944 · Cited by 19 · see citing works
Mental health of children and young people in the WHO Europe region
Tarasenko, A., Josy, G., Minnis, H., Hall, J., Danese, A., Lau, J. Y. F., Cortese, S., Stringaris, A., Redlich, C., & Ougrin, D. (2025) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2025.101459 · Cited by 21 · see citing works
Management of Sleep Disturbances Associated with Smith-Magenis Syndrome
Kaplan, K., Elsea, S. H., & Potocki, L. (2020) · CNS Drugs · doi:10.1007/s40263-020-00733-5 · Cited by 18 · see citing works
- Authors
- Gringras, P., Nir, T., Breddy, J., Frydman-Marom, A., & Findling, R. L.
- Affiliations
- Guy's Hospital (GB)
- Neurim Pharmaceuticals (Israel) (IL)
- Kennedy Krieger Institute (US)
- Corresponding author
- Gringras, Paul
- Venue
- Journal of the American Academy of Child & Adolescent Psychiatry
- Publisher
- Elsevier BV
- Published
- 2017-11
- Volume
- 56
- Issue
- 11
- Pages
- 948-957.e4
- ISSN
- 0890-8567 (ISSN-L)
- OpenAlex
- W2756112142
- Cited by
- 306
- References
- 28
- Citations by year
- 2026: 21 · 2025: 48 · 2024: 41 · 2023: 31 · 2022: 50 · 2021: 31 · 2020: 42 · 2019: 25 · 2018: 16 · 2015: 1
- FWCI
- 29.35
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Keywords
- melatonin, prolonged-release melatonin, pediatric insomnia, autism spectrum disorder, ADHD comorbidity, neurogenetic disorders, Smith-Magenis syndrome, sleep latency, total sleep time, sleep disorders, sleepiness, dysphagia, children and adolescents, treatment efficacy and safety, number needed to treat
- MeSH terms
- Autism Spectrum Disorder, Adolescent, Attention Deficit Disorder with Hyperactivity, Central Nervous System Depressants, Child, Child, Preschool, Delayed-Action Preparations, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Melatonin, Outcome Assessment, Health Care
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