Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study
I'd rather avoid habit-forming medications — is hydroxyzine a reasonable non-addictive alternative to a benzodiazepine for me?
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Pre-registration-era trial; the funding source could not be read from available records.
In a 12-week trial of 334 adults with generalized anxiety, hydroxyzine 50 mg/day lowered Hamilton anxiety scores by about 12 points versus 10 on placebo — a real but modest edge — and worked about as well as the benzodiazepine bromazepam.
Worth asking
I'd rather avoid habit-forming medications — is hydroxyzine a reasonable non-addictive alternative to a benzodiazepine for me?
What it is FDA approved for
Read off the label. Trial duration and approval year are shown only where they were recorded — never inferred.
- Symptomatic relief of anxiety and tension associated with psychoneurosis, and as an adjunct in organic disease states in which anxiety is manifested
- Management of pruritus due to allergic conditions (chronic urticaria, atopic and contact dermatoses) and histamine-mediated pruritus
- Sedation as premedication and following general anesthesia
Source
Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study — Llorca PM, et al. (2002)
Reputable peer-reviewed journal
Read the source: https://doi.org/10.4088/JCP.v63n1112
DOI: 10.4088/JCP.v63n1112
How this was scored
- Study design
- Randomised controlled trial
- Funding
- Funding not disclosed
- Published in
- Reputable peer-reviewed journal
- Sample size
- 334
- Preregistered
- No
- Conflicts disclosed
- No
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 61 out of 100 on our published rubric. One caveat travels with that badge: Pre-registration-era trial; the funding source could not be read from available records. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study — Llorca PM, et al. (2002). Published in: Reputable peer-reviewed journal. DOI: 10.4088/JCP.v63n1112. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Randomised controlled trial. Funding: Funding not disclosed. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is hydroxyzine (Vistaril, Atarax), vistaril, atarax FDA approved?
Yes — FDA approved for Symptomatic relief of anxiety and tension associated with psychoneurosis, and as an adjunct in organic disease states in which anxiety is manifested, Management of pruritus due to allergic conditions (chronic urticaria, atopic and contact dermatoses) and histamine-mediated pruritus, Sedation as premedication and following general anesthesia. Approval is for a specific indication, not for everything the drug is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.