![]() 8, 9 Trazodone also shows a sedating activity, with reviews indicating that insomnia is the most common reason for its off‐label prescription and use in adult and pediatric populations. 7 As a result of the combined serotoninergic receptor antagonism and serotonin reuptake inhibition, trazodone has demonstrated unique therapeutic flexibility, which has given rise to its potential use in a broad range of comorbidities of major depressive disorder as well as off‐label indications, including insomnia. It is indicated primarily for the treatment of depression in patients who do not respond to antidepressants, such as selective serotonin reuptake inhibitors. Trazodone exerts its antidepressant activity acting as serotonin antagonist and reuptake inhibitor. 1, 6 However, because of the paucity of controlled clinical trials, medications for the treatment of pediatric insomnia in children with NDDs still represent an unmet medical need. 5 In children with NDDs, behavioral techniques for sleep induction may not be successful, thus requiring pharmacological interventions. 1, 2, 3, 4 Managing sleep disorders in children is critical both for the child and for the family, and it is often frustrating because of the refractory nature of the problem. Insomnia is a common sleep disorder in children with neurodevelopmental disorders (NDDs) such as autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), Down syndrome, and Rett Syndrome. Clinical trials based on the aforementioned predicted dosing are currently in progress, and pharmacokinetic data obtained will enable further refinement of the PBPK models. An interaction between trazodone and atomoxetine was predicted to be unlikely. Doses predicted in the following age groups, with exposures corresponding to adult dosages of 30, 75, and 150 mg once a day (q.d.), respectively, were: (i) 2‐ to 6‐year‐old group, doses of 0.35, 0.8, and 1.6 mg/kg q.d. The interaction potential between trazodone and atomoxetine was also predicted. Data on the pharmacokinetics of trazodone in children are currently lacking. This study was designed to predict the doses of trazodone to guide dosing in a clinical trial for pediatric insomnia using physiologically‐based pharmacokinetic (PBPK) modeling. Keep from freezing.ĭo not keep outdated medicine or medicine no longer needed.Īsk your healthcare professional how you should dispose of any medicine you do not use.There is a paucity of clinical trials for the treatment of pediatric insomnia. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose of this medicine, take it as soon as possible. However, the dose is usually not more than 400 mg per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 375 mg per day.Ĭhildren-Use and dose must be determined by your doctor.Īdults-At first, 150 milligrams (mg) per day, given in divided doses. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.įor oral dosage form (extended-release tablets):Īdults-At first, 150 milligrams (mg) per day as a single dose. The amount of medicine that you take depends on the strength of the medicine. If your dose is different, do not change it unless your doctor tells you to do so. ![]() The following information includes only the average doses of this medicine. Follow your doctor's orders or the directions on the label. The dose of this medicine will be different for different patients. Do not break the tablet unless your doctor tells you to. ![]() The tablet can be swallowed whole or given as a half tablet by breaking the tablet along the score line. Take the extended-release tablet at the same time each day, preferably at bedtime, without food. To lessen stomach upset and to reduce dizziness and lightheadedness, take the regular tablet with or shortly after a meal or light snack. Ask your doctor or pharmacist if you have any questions. Read and follow these instructions carefully. This medicine should come with a Medication Guide. ![]()
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