FDA Clears Path for Generic Sleep-Aid Tablets
Published Date: 7/9/2026
Notice
Summary
The FDA has decided that TOVALT ODT tablets (5 mg and 10 mg) weren’t taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions, making it easier and cheaper for people who need this sleep aid. If approved, more affordable options could hit the shelves soon, helping patients and saving money.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Generics May Be Approved for TOVALT ODT
The FDA determined that TOVALT ODT (zolpidem tartrate) orally disintegrating tablets, 5 mg and 10 mg, were not withdrawn for reasons of safety or effectiveness. Because of that decision, the FDA can approve abbreviated new drug applications (ANDAs) that refer to these 5 mg and 10 mg products if the ANDA meets all other legal and regulatory requirements.
Orange Book Listing and ANDA Labeling Guidance
FDA will continue to list TOVALT ODT (zolpidem tartrate) 5 mg and 10 mg in the "Discontinued Drug Product List" section of the Orange Book, which denotes discontinuation for reasons other than safety or effectiveness. ANDAs that refer to these listed products may be approved if they meet legal requirements, and FDA said it will advise ANDA applicants to submit revised labeling if the Agency determines labeling should be updated to meet current standards.
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