Yes, Immediate-Release Guanfacine (Tenex) Is Available in the United States
Yes, immediate-release guanfacine, marketed as Tenex, is available in the United States in 1 mg and 2 mg tablet formulations 1.
Formulation Details
The FDA-approved immediate-release formulation (Tenex) comes as:
- 1 mg tablets: Light pink, diamond-shaped
- 2 mg tablets: Yellow, diamond-shaped 1
This is distinct from the extended-release formulation (Intuniv) that is FDA-approved specifically for ADHD treatment.
Clinical Context and Usage
FDA-Approved Indication
Immediate-release guanfacine (Tenex) is FDA-approved for hypertension treatment in adolescents and adults 2. It has been available since 1975 3.
Off-Label ADHD Use
Despite not having FDA approval for ADHD, immediate-release guanfacine has been used off-label for several years in children for ADHD and pervasive developmental disorders 2. This is an important distinction from extended-release guanfacine, which has FDA approval for ADHD treatment 4.
Key Differences from Extended-Release
The evidence consistently emphasizes that only extended-release guanfacine and extended-release clonidine have FDA approval for ADHD treatment 4, 5. Current ADHD guidelines specifically reference extended-release formulations when discussing guanfacine as an approved ADHD medication 4.
Clinical Considerations
Dosing Differences
- Immediate-release (Tenex): Typically dosed multiple times daily for hypertension
- Extended-release (Intuniv): Once-daily dosing, weight-adjusted (approximately 0.1 mg/kg) for ADHD 5
Common Uses in Practice
Immediate-release guanfacine remains commonly used for clinically significant hyperactivity, impulsivity, or disruptive behaviors, particularly in very young children (<6 years) where it may be prescribed off-label 6. Recent case reports also suggest efficacy for impulsivity-related symptoms in other conditions 7, 8.
Important Caveat
While immediate-release guanfacine exists and is used clinically, the robust evidence base for ADHD treatment specifically supports extended-release formulations 4, 5. The extended-release version has undergone rigorous clinical trials demonstrating efficacy and safety for ADHD, which the immediate-release formulation has not 2, 9.