There are very few prescription medications approved for autism spectrum disorders. Some feel this encourages off-label use of drugs to alleviate challenging autism symptoms of children on the spectrum. Clonidine is one such drug; frequently mentioned as a beneficial treatment option for sleep disturbances and behavioral challenges.
Parents often experience frustration due to the lack of prescription medication available for their children with autism spectrum disorder (ASD). Aggressive behavior, sleep disturbances, and irritability are some of the symptoms parents may want to address with appropriate medication. Could clonidine for autism, a drug associated with lowering blood pressure, help with some of these symptoms, and is it safe? Some research seems encouraging about this drug dating back to the 60s.
From nasal decongestant to attention deficit hyperactivity treatment
Clonidine dates back to about 1962 when it was developed as a nasal decongestant (Oesterheld & Tervo, 1996) by pharmaceutical manufacturer Boehringer Ingelheim. Gradually, the focus was changed as the drug gained recognition for its ability to lower blood pressure, leading to FDA approval for the treatment of hypertension in 1974.
Clonidine is part of a class of prescription drugs called central alpha agonists, these drugs work in the brain to lower blood pressure. Sold under the names Catapres and Kapvay among others, discoveries of more uses for the drug changed its focal point; it evolved from a purely antihypertensive medication to being used more frequently to address psychiatric entities (Naguy, 2016).
The drug is FDA approved to treat attention deficit hyperactivity disorder (ADHD) and for many years it has been used (off-label) to treat conditions like:
- Tourette’s syndrome
- Menopausal flushing
- Opioid Withdrawal
- Smoking cessation
- Restless leg syndrome
But what about children with autism? Will a medication involved in lowering blood pressure provide relief for any of the symptoms challenging kids on the spectrum? Limited research found some positive evidence.
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Clonidine for autism spectrum disorders
An open-labeled, retrospective study (Ming et al. 2008) of clonidine in treating insomnia, in addition to/or hyperactivity, inattention, mood disorder, and aggressive behavior was conducted by utilizing reports from parents concerning sleep and behaviors before and during clonidine treatment.
Results from the study (Ming et al. 2008) showed clonidine was effective in treating specific sleep disturbances, like sleep initiation latency and night awakening, but also mood instability and aggressiveness, to a lesser degree, in 19 children with autism. The authors mention side effects were largely tolerated and they recommended further studies to test the medication in ASD for improved insight.
Another study (Leskovec et al., 2008) titled Pharmacological treatment options for autism spectrum disorders in children and adolescents reviewed the efficacy and tolerability of pharmacological interventions for autism spectrum disorders. The authors mention that though there is no cure, many of the challenging symptoms may be treated pharmacologically.
Unfortunately, there is a very limited base of evidence concerning the efficacy of clonidine for behavioral difficulties and other challenging ASD symptoms. However, available evidence does suggest the drug may be tolerated and could be successful in treating concerns like insomnia, sleep disturbances, hyperactivity, and behavioral disturbances.
The current evidence base needs to be expanded, given the scarcity of pharmacological options for treating challenging behaviors in those on the spectrum. A clonidine trial may be a suitable, cost-effective pharmaceutical option (Banas & Sawchuck, 2020).
Clonidine for attention deficit hyperactivity disorder comorbid with autism
Finding reliable statistics about the co-occurrence of ASD and attention deficit hyperactivity disorder (ADHD) in children is difficult. In fact, some believe it is impossible to discern between symptom profiles of the two conditions. Estimates that more than half of children on the spectrum also display ADHD symptoms are particularly relevant when considering clonidine.
Clonidine (more specifically Kapvay, the extended-release version of the drug) was approved by the FDA for children ages six and up, with ADHD. It is a non-stimulant medication with no appetite effect. It may enhance the effect of stimulants in addition to treating sleep difficulties and reducing anxiety.
Some parents share that the “true” benefits of clonidine only become apparent when combined with stimulant medication for ADHD. This was backed up by research when a study (Kollins et al., 2011) found extended-release clonidine combined with stimulant medication works well to reduce symptoms of ADHD. The authors also found the medication is well tolerated.
As the drug is approved as a medication for ADHD in the pediatric population, there is a body of research available that delves into clonidine’s side effects in this vulnerable group. While more research is needed to ascertain specific side effects for children on the spectrum, the study results may be of interest to parents with autistic children.
Side effects of clonidine
Even though research (Luan et al., 2017) lauds clonidine hydrochloride’s “appreciable effectiveness and tolerability” there are serious side effects parents should take note of before considering the drug for their children.
In a study (Joo & Ki, 2018) assessing the safety and effectiveness of extended-release clonidine, in Korean children and adolescents with ADHD and/or Tourette’s syndrome, 65.5% of subjects experienced adverse effects. The most common effect experienced was drowsiness or sleepiness which, according to the authors, resolved in most cases. Other side effects mentioned in the study include:
- A decrease in blood pressure
- Night terrors
- Aggravation of motor and vocal tics
Reading anecdotal accounts, it becomes clear that—though effective for irritability, sleep troubles, and challenging behaviors—parents are worried about serious (though mostly uncommon) adverse effects like bradycardia, weakness, drowsiness, and dry mouth.
Even though most studies mention the relative safety and tolerance of clonidine in pediatrics, all seem to agree that more research and clinical trials are necessary. This is especially relevant for children on the autism spectrum; because autism is characterized by deficits in communication, extra care is needed when trying any new pharmacological intervention.
Parents should consult with their child’s pediatrician and/or psychiatrist before considering any new treatment for autism. Clonidine is not approved for autism spectrum disorder, the use of this medication is considered off-label, which means parents should proceed with caution.
Unfortunately, because there are so few approved treatment options available for ASD and its related symptoms, most parents feel they have little choice but to experiment with (off-label use of) medication until they find something that works for their child. These parents feel the research community should spend their resources on trials to find better solutions for challenging symptoms rather than increasingly trying to figure out the cause and intricacies behind the condition.
A safe drug treating sleep disturbances, anxiety, hyperactivity, and behavioral challenges in autism sounds too good to be true. Only a randomized double-blind placebo control study could tell us if it is.
Banas, K., & Sawchuk, B. (2020). Clonidine as a Treatment of Behavioural Disturbances in Autism Spectrum Disorder: A Systematic Literature Review. Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l’Academie canadienne de psychiatrie de l’enfant et de l’adolescent, 29(2), 110–120.
Joo, S. W., & Kim, H. W. (2018). Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder and/or Tourette’s Disorder with Clonidine Extended-Release. Psychiatry Investigation, 15(1), 90–93. https://doi.org/10.4306/pi.2018.15.1.90.
Kollins, S. H., Jain, R., Brams, M., Segal, S., Findling, R. L., Wigal, S. B., & Khayrallah, M. (2011). Clonidine extended-release tablets as add-on therapy to psychostimulants in children and adolescents with ADHD. Pediatrics, 127(6), e1406–e1413. https://doi.org/10.1542/peds.2010-1260.
Leskovec, T. J., Rowles, B. M., & Findling, R. L. (2008). Pharmacological treatment options for autism spectrum disorders in children and adolescents. Harvard review of psychiatry, 16(2), 97–112. https://doi.org/10.1080/10673220802075852.
Luan, R., Mu, Z., Yue, F., & He, S. (2017). Efficacy and Tolerability of Different Interventions in Children and Adolescents with Attention Deficit Hyperactivity Disorder. Frontiers in psychiatry, 8, 229. https://doi.org/10.3389/fpsyt.2017.00229.
Ming, X., Gordon, E., Kang, N., & Wagner, G. C. (2008). Use of clonidine in children with autism spectrum disorders. Brain & development, 30(7), 454–460. https://doi.org/10.1016/j.braindev.2007.12.007.
Naguy A. (2016). Clonidine Use in Psychiatry: Panacea or Panache. Pharmacology, 98(1-2), 87–92. https://doi.org/10.1159/000446441.
Oesterheld, J., & Tervo, R. (1996). Clonidine: a practical guide for usage in children. South Dakota journal of medicine, 49(7), 234–237.