Medication approval journey
alprazolam (Xanax)
Approved for Generalized anxiety disorder and panic disorder
Before changing anything
Stopping abruptly can be dangerous — never do it without medical supervision
Do not stop a benzodiazepine abruptly. Abrupt withdrawal can cause seizures, delirium, and can be fatal. Physical dependence develops within weeks of daily use and is not the same thing as addiction. Coming off safely is a prescriber-supervised taper measured in months, sometimes far longer, and going slower is not failure.
How long the trials actually ran
The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.
The approval, step by step
Step 1
What the approval was actually based on
Which studies did the FDA rely on, how long did they run, and who was in them?
Alprazolam was significantly better than placebo at each of the evaluation periods of these 4-week studies... The effectiveness of alprazolam in the treatment of panic disorder was studied in 3 short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- October 16, 1981
- Application
- NDA018276
- Review
- STANDARD
Step 3
What was added after it was on the market
Which warnings arrived only after millions of people were already taking it?
Step 4
What independent research has found since
What has been learned by people who were not selling it?
Step 5
What still is not known
Which questions you might reasonably have has nobody answered yet?
Open alprazolam (Xanax) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
