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Kapvay was a prescription extended-release clonidine hydrochloride product approved for attention deficit hyperactivity disorder as monotherapy or with stimulant medicines. FDA Orange Book records list the 0.1 mg and 0.2 mg Kapvay products as discontinued. Generic clonidine hydrochloride extended-release tablets remain marketed for the same ADHD indication.
read more about what was kapvay ...Clonidine is a centrally acting alpha-2 adrenergic agonist. Its exact mechanism in attention deficit hyperactivity disorder is not established. Its sympatholytic activity can lower heart rate and blood pressure.
Kapvay was used for attention deficit hyperactivity disorder as monotherapy or with stimulant medicines. Current generic extended-release clonidine labeling establishes safety and efficacy for ADHD in pediatric patients age 6 through 17 and does not establish use below age 6.
Treatment started with 0.1 mg at bedtime for one week. The daily dose increased by 0.1 mg at weekly intervals according to response, with doses above 0.1 mg divided between morning and bedtime. The maximum studied and recommended daily dose was 0.4 mg. Discontinuation used a gradual taper of no more than 0.1 mg every three to seven days.
Extended-release clonidine can cause low blood pressure, slow heart rate, sedation, somnolence, syncope, and cardiac conduction abnormalities. Abrupt discontinuation can cause rebound hypertension. Blood pressure and heart rate are checked before treatment, after dose increases, and periodically during therapy.
No. FDA Orange Book records list both Kapvay strengths as discontinued.
Kapvay contained extended-release clonidine hydrochloride.
The starting dose was 0.1 mg at bedtime.
Yes. Current generic products retain the ADHD indication associated with the former Kapvay regimen.
Clonidine: MedlinePlus Drug Information. https://medlineplus.gov/druginfo/meds/a682243.html. Date Accessed October 7, 2026.
Clonidine Extended-Release Tablets for Pediatric Patients With Attention-Deficit/Hyperactivity Disorder. https://pubmed.ncbi.nlm.nih.gov/21241954/. Date Accessed October 7, 2026.
Clonidine Hydrochloride Extended-Release Tablets Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=99485427-a120-4fc7-bb61-25857d1900ec. Date Accessed October 7, 2026.
KAPVAY (Clonidine Hydrochloride) Extended-Release Tablets Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022331s014lbl.pdf. Date Accessed October 7, 2026.
Multidiscipline Review: ONYDA XR (Clonidine Hydrochloride Extended-Release Oral Suspension). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217645Orig1s000MultidisciplineR.pdf. Date Accessed October 7, 2026.