FDA shuts down sleep aid dreams for HETLIOZ capsules.
Published Date: 3/7/2025
Notice
Summary
The FDA said no to Vanda Pharmaceuticals' request to approve HETLIOZ capsules for helping people who have trouble falling asleep. They also denied Vanda’s ask for a hearing to challenge this decision. This means the drug won’t be approved for this new use anytime soon, affecting patients hoping for a new insomnia treatment and Vanda’s plans to expand their product line.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Refusal to Approve HETLIOZ for Insomnia
The FDA refused to approve supplemental NDA 205677-012 for HETLIOZ (tasimelteon) capsules, 20 mg, as a treatment for insomnia characterized by difficulties with sleep initiation, and denied Vanda Pharmaceuticals' request for a hearing. The FDA issued that decision on February 28, 2025, so HETLIOZ will not be approved for that new use at this time.
Existing HETLIOZ Approvals Remain
HETLIOZ (tasimelteon) remains approved under NDA 205677 (approved January 31, 2014) for non-24-hour sleep-wake disorder and under NDA 214517 (approved December 1, 2020) for nighttime sleep disturbances in pediatric patients with Smith-Magenis Syndrome. Those prior approvals are unchanged by the February 28, 2025 decision.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20063, Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees
The FDA is looking for smart, qualified people to join its advisory committees and help make important decisions about food and drugs. If you have the right skills, you can apply anytime, but get your nomination in by November 30, 2026, for the best chance at current openings. This is a great chance to influence public health without any cost to you!
Previous / Next Documents
Previous: 2025-03696, U.S. Integrated Ocean Observing System (IOOS®) Advisory Committee Public Meeting Cancelled
The U.S. Integrated Ocean Observing System (IOOS) Advisory Committee’s public meeting planned for March 12-14, 2025, has been cancelled. This affects committee members and anyone interested in ocean observing updates, but no new dates or costs were mentioned. If you were planning to attend or follow the meeting, stay tuned for future announcements!
Next: 2025-03699, Arbitrator's Personal Data Questionnaire
The Federal Mediation and Conciliation Service (FMCS) is updating its Arbitrator's Personal Data Questionnaire, which helps keep a list of qualified arbitrators who are private citizens, not government employees. This update asks for public feedback by May 6, 2025, to make sure the form is clear, useful, and not a hassle to fill out. No new costs are mentioned, but the changes help FMCS keep only the best arbitrators on their roster.