Onyda XR

(clonidine hydrochloride extended-release oral suspension, 0.1 mg/mL)
Onyda XR (clonidine hydrochloride); not controlled
Full Prescribing Information
DailyMed Drug Information
Summary
Onyda XR is extended-release clonidine as an orange-flavoured oral suspension, a central alpha-2 adrenergic agonist approved for ADHD in patients 6 years and older, as monotherapy or added to a stimulant. It is the only clonidine product dosed once daily at bedtime, and the only liquid alpha-2 agonist, which is what recommends it for a child who cannot swallow tablets or who needs a dose the tablet cannot make. Not controlled; brand only, from a single manufacturer.
Forms & Strengths
Extended-release oral suspension (orange, light beige to tan, viscous): 0.1 mg/mL
Dose maps to volume: 0.1 mg is 1 mL, 0.2 mg is 2 mL, 0.3 mg is 3 mL, 0.4 mg is 4 mL
Dosing
Age: 6 y/o and older; not established below 6 years
Onset: sedation within hours; ADHD benefit over weeks, trial endpoint at 5 weeks
Duration: once daily; clonidine half-life 12 to 16 hours, up to 41 in severe renal impairment
Release Profile: clonidine complexed with sodium polystyrene sulfonate; 0.095 mg/mL resin-bound plus 0.005 mg free. Steady-state exposure close to ER tablets twice daily, trough about 26% lower
Initial Dose: 0.1 mg (1 mL) once daily at bedtime, with or without food
Titration: 0.1 mg/day every 7 days
Max Dose: 0.4 mg (4 mL) once daily at bedtime; higher doses were not evaluated
Considerations: Shake gently at least 10 seconds before every dose and measure only with the supplied dispenser. Do not substitute for any other clonidine product mg-for-mg, and never stop abruptly.
For patients switching from another clonidine product, discontinue that treatment and titrate Onyda XR from 0.1 mg. Do not substitute milligram for milligram; the pharmacokinetic profiles differ.
Pharmacology
Mechanism: Central alpha-2 adrenergic agonist; reduces sympathetic outflow from the locus coeruleus and enhances prefrontal noradrenergic signalling. Not a CNS stimulant; mechanism in ADHD unknown.
Delivery / Release: Resin-complexed extended release; median Tmax 7.5 hours (range 4 to 17) against 3 to 5 for immediate release. Steady-state peak 107.9% and exposure 97.7% of ER tablets. Food has no effect.
Metabolism: About 50% hepatic, 40% to 60% renal unchanged. Half-life 12 to 16 hours, up to 41 hours in severe renal impairment.
Alcohol and dose dumping: in vitro, 20% alcohol produced faster and more variable release; 5% and 10% did not.
Class Positioning: Non-selective, more sedating than guanfacine (Intuniv). Same pharmacology as clonidine ER tablets but once daily and measurable to any dose; IR clonidine is not ADHD approved.
Indications
ADHD, as monotherapy (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older
ADHD, as adjunctive therapy to CNS stimulants (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older
Off-Label Uses
Tic disorders and Tourette syndrome (ICD-10: F95.1, F95.2): supported by controlled trials for the class, limited data for this product. (AACAP 2013)
Sleep-onset insomnia in ADHD (ICD-10: G47.00): limited data. Somnolence is a labeled adverse effect, but this is the only clonidine whose labeled schedule is a single bedtime dose.
Where the evidence does not support use:
Children under 6 (ICD-10: F90.x): insufficient (AHRQ 2018), though the liquid makes dosing a preschooler easy
Oppositional defiant disorder and aggression (ICD-10: F91.3): insufficient
Anxiety and PTSD (ICD-10: F41.x, F43.1): insufficient
Contraindications & Warnings
Contraindicated: history of hypersensitivity to clonidine, including generalised rash, urticaria or angioedema
Use with caution:
Hypotension, heart block, bradycardia, cardiovascular or cerebrovascular disease, renal failure; titrate slowly
Syncope, orthostatic hypotension, or a tendency to dehydration; avoid dehydration and overheating
Conduction abnormality or concurrent sympatholytics; severe bradycardia needing pacing reported
Concurrent CNS depressants, because of additive sedation
Renal impairment; set the initial dose by degree of impairment
Recurrent vomiting illness, named in this label: missed doses raise the rebound hypertension risk
Prior sensitisation to the clonidine patch; oral use may cause generalised rash
Screen before starting:
Heart rate and blood pressure, supine and standing; the label makes this mandatory
Syncope, palpitations, conduction disease, family history of sudden cardiac death, and all sedating or sympatholytic co-medication
Renal function
Whether the family can measure a liquid dose reliably and track the discard window
Drug Interactions
Sinus node and AV nodal agents (digitalis, calcium channel blockers, beta-blockers): additive bradycardia and AV block; label says avoid use. If unavoidable, check vitals each visit
CNS depressants (alcohol, barbiturates, benzodiazepines, phenothiazines, sedating antihistamines): potentiated sedation; reduce or avoid, and counsel adolescents on alcohol
Antihypertensives: potentiated hypotension; monitor blood pressure and adjust
Tricyclic antidepressants: may reduce the hypotensive effect; recheck blood pressure when either is started or stopped
Amphetamine: clonidine clearance 44% lower, and 11% higher with methylphenidate; titrate more cautiously and watch for sedation and bradycardia
Administration
Once daily at bedtime, with or without food
Insert the press-in bottle adapter before first use and leave it in place
Shake gently up and down at least 10 seconds before every dose; vigorous shaking foams it and spoils the draw
Measure only with the supplied oral dispenser, never a spoon
Supplied in 30 mL, 60 mL and 120 mL bottles
Discard 30 days after opening a 30 mL or 60 mL bottle, 60 days after opening a 120 mL bottle. Store at room temperature, protected from light
Missed dose: skip it; never exceed the prescribed daily total
Switching: stop the other product and titrate from 0.1 mg; never convert mg-for-mg from ER tablets or IR clonidine
Do not stop abruptly; see Discontinuation & Taper
Side Effects
Common (at least 5% and twice placebo, from the ER tablet trials this label cites):
Somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth
Somnolence 38% at 0.2 mg/day and 31% at 0.4 mg/day, vs 4% placebo
As adjunct: somnolence 19% vs 7%, plus fatigue, decreased appetite, dizziness
Serious:
Rebound hypertension on abrupt discontinuation; this label adds that a vomiting illness causing missed doses raises that risk
Dose-related hypotension and bradycardia; hold or reduce and recheck
Syncope; stop and check orthostatic vitals before further titration
Conduction abnormality or AV block; severe bradycardia has needed pacing. Obtain an ECG and stop
Allergic reactions including generalised rash, urticaria and angioedema; discontinue
Monitoring & Labs
Heart rate and blood pressure: baseline, 1 to 2 weeks after each increment, then every 3 months; hold titration for bradycardia by age
Orthostatics: lying and standing at baseline, every dose change, and any dizziness visit
Sedation: ask about morning grogginess at every titration visit and every visit for 3 months
Rebound hypertension risk: at every refill confirm no missed doses or supply gap, and ask about recent gastroenteritis
Dosing technique: at first follow-up have the caregiver demonstrate shaking and drawing the dose
ADHD response: rated scale at 5 to 8 weeks, matching the bridged trial endpoint
ECG: not routine; baseline if conduction disease, syncope history or concurrent sympatholytics, and promptly for new syncope or bradycardia
Renal function: baseline and annually
Laboratory: no routine laboratory monitoring required
Discontinuation & Taper
Never stop abruptly. Reduce by no more than 0.1 mg (1 mL) every 3 to 7 days; from 0.4 mg that is 12 days to 4 weeks
Abrupt cessation in adults: headache, tachycardia, nausea, flushing, chest tightness, anxiety
With immediate-release clonidine: nervousness, agitation, tremor and a rapid rise in blood pressure
A vomiting illness is de facto abrupt discontinuation, named in this label for children; families should call, and recheck blood pressure afterwards
Measure blood pressure and heart rate at each taper step and after the last dose
Drug holidays are not appropriate for this class. Weekend and summer breaks are a rebound hypertension risk here
Pregnancy & Lactation
Pregnancy: decades of human use show no identified risk of major birth defects, miscarriage or adverse outcomes. Animal resorptions at 10x (rat) and 5x (mouse) the maximum human dose; no rabbit effect to 3x.
Lactation: relative infant dose 4.1% to 8.4%; milk levels about double maternal serum. Most infants unaffected; one case of sedation, hypotonia and apnoea. Monitor for lethargy, tachypnoea and poor feeding. (LactMed 2024)
Lactation, milk supply: dose-related oxytocin and prolactin effects, with postpartum galactorrhea reported. Other agents are preferred while nursing a newborn or preterm infant. (LactMed 2024)
Fertility: animal findings suggest impaired fertility in both sexes
Exposure Registry: National Pregnancy Registry for Psychiatric Medications, 1-866-961-2388, womensmentalhealth.org
Counseling Points
Counsel the family on:
Shaking gently 10 seconds before every dose, and using only the supplied dispenser; an unshaken bottle underdoses early and overdoses late
Writing the opening date on the bottle, because it is discarded at 30 or 60 days whether or not it is empty
The bedtime-only schedule; this is not the twice-daily tablet and the dose does not carry across
Sleepiness early being expected while the ADHD benefit takes weeks; watch for morning grogginess
Never stopping on their own; name rebound high blood pressure in those words, and never doubling a missed dose
Calling during any stomach bug that stops the medicine going down
Avoiding alcohol in adolescents, for sedation and because alcohol can speed release
Advise them to call for:
Fainting, or dizziness on standing that does not settle
A pulse that feels very slow or irregular
Morning sleepiness affecting school, or a child hard to wake
Severe headache with blurred vision, especially after missed doses
New hives, facial or lip swelling, or a widespread rash
Any vomiting illness that stops the medicine going down
References
DailyMed. Onyda XR (clonidine hydrochloride) extended-release oral suspension prescribing information. NextWave Pharmaceuticals. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a15c850-9da5-4bdc-a34d-7f740a6149b7
DailyMed. Clonidine hydrochloride extended-release tablets prescribing information. Actavis Pharma, Inc. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0100c70d-7fde-46a1-8374-940550a27e43
LactMed. Clonidine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2024. https://www.ncbi.nlm.nih.gov/books/NBK501628/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
AACAP. Practice parameter for the assessment and treatment of children and adolescents with tic disorders. Journal of the American Academy of Child and Adolescent Psychiatry. 2013. https://www.jaacap.org/article/S0890-8567(13)00695-3/fulltext
AHRQ. Attention deficit hyperactivity disorder: diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 203. 2018. https://www.ncbi.nlm.nih.gov/books/NBK487764/
FDA. openFDA National Drug Code Directory, clonidine, queried by generic name across all labelers. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22clonidine%22&limit=1000