Tianeptine proposed for Schedule I

The DEA has proposed placing tianeptine, a tricyclic antidepressant with opioid-like effects, in Schedule I of the Controlled Substances Act — a proposed rule published July 8, 2026, and not in effect. The proposed rule was published in the Federal Register on July 8, 2026 [1]; the FDA has separately warned about tianeptine products it calls "Gas Station Heroin" [1], and poison-center exposures have risen sharply in recent years [1]. This is a notice of proposed rulemaking, not a final rule — tianeptine is not scheduled yet, and handling it is not a federal offence by reason of this docket [1]. It remains uncontrolled under the CSA today [1]. Comments are open until August 7, 2026 [1]; if the rule is finalized, Schedule I's full regulatory controls and criminal penalties would attach to anyone who manufactures, distributes, or possesses it [1].

For someone using it now, tianeptine's federal legal status has not changed. Tianeptine is a tricyclic antidepressant that also acts as a mu-opioid agonist [1], prescribed elsewhere at 12.5 mg three times daily [1], but U.S. products have been found containing hundreds to over 1,000 mg per dosage unit [1], with case reports of daily doses up to 10,000 mg [1]. There are no FDA-approved tianeptine products in the U.S. [1].

Cessation of tianeptine use can lead to withdrawal symptoms similar to those of other opioids [1], including agitation, nausea, vomiting, tachycardia, hypertension, diarrhea, tremor, and diaphoresis [1]. Tianeptine itself clears fast, with a half-life around 2.5 hours [1], but its MC5 metabolite has a half-life of 7 to 12 hours [1]. Overdose has produced respiratory depression, severe sedation, and death [1], and naloxone has reversed some tianeptine overdoses [1] — worth knowing for anyone nearby. Poison-center exposures rose 1,400 percent between 2015 and 2023 [1], and 40.1 percent of reported exposures required medical admission, including 22.9 percent that went to a critical care unit [1].
Procedurally, this follows HHS's recommendation that tianeptine go into Schedule I [1], based on an evaluation HHS delivered in July 2025 after DEA submitted its data in September 2023 [1]. Several states already ban or control the drug [1], as do a handful of other countries [1]. What happens next is the public comment period through August 7 [1]; Schedule I's controls and penalties would attach only if the rule is finalized [1].

References

1. Schedules of Controlled Substances: Placement of Tianeptine in Schedule I — Federal Register