What are the generic and brand names of sleep medications, and are they controlled substances?

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Last updated: May 19, 2026 • View editorial policy

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Sleep Medications: Generic Names, Brand Names, and Controlled Substance Status

Most prescription sleep medications approved by the FDA are controlled substances, classified as either Schedule IV (benzodiazepines and Z-drugs) or Schedule III (suvorexant), while melatonin receptor agonists and low-dose doxepin are not controlled substances. 1

FDA-Approved Sleep Medications

Benzodiazepine Receptor Agonists (Z-Drugs) - Schedule IV Controlled Substances

  • Eszopiclone (Brand: Lunesta)

    • Controlled Substance: YES - Schedule IV
    • Used for sleep onset and maintenance insomnia 1

  • Zaleplon (Brand: Sonata)

    • Controlled Substance: YES - Schedule IV
    • Used for sleep onset insomnia 1

  • Zolpidem (Brands: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist)

    • Controlled Substance: YES - Schedule IV
    • Used for sleep onset and maintenance insomnia 1

Benzodiazepines - Schedule IV Controlled Substances

  • Triazolam (Brand: Halcion)

    • Controlled Substance: YES - Schedule IV
    • Used for sleep onset insomnia 1

  • Temazepam (Brand: Restoril)

    • Controlled Substance: YES - Schedule IV
    • Used for sleep onset and maintenance insomnia 1

Orexin Receptor Antagonist - Schedule IV Controlled Substance

  • Suvorexant (Brand: Belsomra)
    • Controlled Substance: YES - Schedule IV
    • Used for sleep maintenance insomnia 1

Melatonin Receptor Agonist - NOT a Controlled Substance

  • Ramelteon (Brand: Rozerem)
    • Controlled Substance: NO
    • Used for sleep onset insomnia 1

Tricyclic Antidepressant (Low-Dose) - NOT a Controlled Substance

  • Doxepin (Brand: Silenor, when used at low doses 3-6 mg)
    • Controlled Substance: NO
    • Used for sleep maintenance insomnia 1

Important Clinical Considerations

Controlled Substance Implications

All benzodiazepines and Z-drugs carry significant risks including daytime memory impairment, psychomotor dysfunction, complex sleep behaviors (sleep-driving), potential for dependence, and association with dementia (hazard ratio 2.34) in observational studies 2. These medications require careful prescribing practices, monitoring for abuse potential, and adherence to state and federal controlled substance regulations.

Non-Controlled Alternatives

Ramelteon and low-dose doxepin offer treatment options without controlled substance restrictions, making them preferable for patients with substance abuse history or when long-term treatment is anticipated without abuse liability concerns 1, 3.

Medications NOT Recommended

The American Academy of Sleep Medicine guidelines explicitly recommend against using the following for insomnia treatment 1:

  • Trazodone (not controlled, but not recommended due to insufficient evidence)
  • Diphenhydramine (OTC antihistamine - not controlled, not recommended)
  • Melatonin (OTC supplement - not controlled, not recommended for insomnia disorder)

Common Pitfall

Many clinicians prescribe trazodone off-label for insomnia because it is not a controlled substance, but guidelines explicitly recommend against this practice due to lack of efficacy evidence and potential harms outweighing benefits 1. If avoiding controlled substances is the goal, ramelteon or low-dose doxepin are evidence-based alternatives.

References

1
Guideline

clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an american academy of sleep medicine clinical practice guideline.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2017

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