Is Trazodone a Controlled Substance?
No, trazodone is not a controlled substance according to the FDA drug label, which explicitly states that "Trazodone Hydrochloride Tablets are not a controlled substance." 1
Regulatory Classification
- The FDA has determined that trazodone does not meet criteria for scheduling as a controlled substance by the US Drug Enforcement Administration 1
- Preclinical and clinical studies have shown no indication of drug-seeking behavior with trazodone use 1
- Trazodone has demonstrated low abuse potential in clinical investigations 2
Clinical Context for Sleep Use
While trazodone is not a controlled substance, it's important to understand its appropriate role in sleep medicine:
- The American Academy of Sleep Medicine explicitly recommends AGAINST using trazodone for sleep onset or sleep maintenance insomnia in adults 3
- Clinical trials of trazodone 50 mg showed only modest improvements in sleep parameters with no improvement in subjective sleep quality, and the harms were deemed to outweigh benefits 3
- Despite widespread off-label use for insomnia, trazodone is FDA-approved only for major depressive disorder, not for sleep disorders 4, 5
Prescribing Implications
- Because trazodone is not a controlled substance, it does not require special DEA prescribing authorization or triplicate prescription forms 1
- However, its non-controlled status does not indicate it is the preferred choice for insomnia treatment 3
- Trazodone is commonly prescribed off-label as a hypnotic (at doses of 25-50 mg) despite lack of strong efficacy evidence, largely because physicians have concerns about prescribing controlled substances like benzodiazepines 6, 5
Preferred Alternatives
The American Academy of Sleep Medicine recommends several FDA-approved medications over trazodone for insomnia, including:
- Eszopiclone, zolpidem, and zaleplon for sleep onset and/or maintenance 3
- Suvorexant for sleep maintenance insomnia 3
- Ramelteon for sleep onset insomnia 3
- Low-dose doxepin (3-6 mg) for sleep maintenance 3
These agents have stronger evidence for efficacy and are specifically approved for insomnia treatment, though some are Schedule IV controlled substances 3.