Hydroxyzine Is NOT a Controlled Substance and Can Be Prescribed for 30 Days
Hydroxyzine is an unscheduled (non-controlled) first-generation antihistamine that can legally be prescribed for 30 days or longer without the restrictions that apply to controlled substances. 1
Regulatory Status
- Hydroxyzine is classified as an unscheduled medication, meaning it is not subject to DEA controlled substance regulations 1
- This allows healthcare providers to prescribe it for extended periods, including 30-day supplies, without the limitations imposed on Schedule II-V medications 1
- No special prescribing requirements, prescription monitoring programs, or refill restrictions apply 1
Clinical Prescribing Considerations
While hydroxyzine can be legally prescribed for 30 days, the British Journal of Dermatology advises against extended monotherapy with hydroxyzine, favoring its use as a nighttime adjunct to non-sedating antihistamines rather than as standalone long-term treatment 2
Typical Duration Guidelines:
- For mild to moderate itching: 2-4 weeks is appropriate 2
- For urticaria/anxiety: Can be used longer-term but preferably as nighttime adjunct (10-50 mg at bedtime) combined with non-sedating antihistamines during the day 3, 4
- Long-term management: Transition to non-sedating antihistamines is recommended for extended use 2
Important Safety Considerations for 30-Day Prescriptions
High-Risk Populations Requiring Caution:
- Elderly patients: Should be started at low doses with close monitoring for confusion, over-sedation, and fall risk; hydroxyzine is listed among medications to deprescribe in older adults due to fall risk 2, 4
- Renal impairment: Reduce dose by half in moderate impairment (CrCl 10-20 mL/min); avoid entirely if CrCl <10 mL/min 3, 4
- Hepatic disease: Avoid in severe liver disease due to sedating effects 3, 2, 4
- Pregnancy: Specifically contraindicated during early pregnancy 3, 4
Common Pitfalls to Avoid:
- CNS depression: Avoid concomitant use with other CNS depressants as this enhances performance impairment and sedation 2
- Driving impairment: Hydroxyzine can significantly impair driving performance with observations including erratic driving, crashes, and difficulty with coordination 1
- Sedation rates: Hydroxyzine causes 80% sedation rates compared to 50% with diphenhydramine 2
Practical Prescribing Algorithm
For a 30-day prescription, use this approach:
- Standard dosing: 10-50 mg at bedtime for pruritus/anxiety 2, or 10-25 mg four times daily for more severe symptoms 3
- Elderly/high-risk patients: Start at 10 mg and titrate cautiously 4
- Renal impairment: Halve the dose if CrCl 10-20 mL/min 3, 4
- Counsel patients about sedation, driving impairment, and avoiding alcohol/CNS depressants 2, 1
- Plan transition to non-sedating antihistamines if symptoms require treatment beyond 2-4 weeks 2