Sleep Disorder (Sedative-Hypnotic) Drug Information
Sedative-hypnotic drug products are a class of drugs used to induce and/or maintain sleep.
FDA Drug Safety Communications:
- FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines (4/30/2019)
- FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks (9/20/2017)
- FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning (8/31/2016)
- FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose (5/15/2014)
- FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR (5/14/2013)
Prescription Insomnia Drugs (UPDATED)
For prescribing information, please search the Drugs@FDA database.
- Ambien (zolpidem)
- Belsomra (suvorexant)
- Butisol (butabarbital)
- Dayvigo (lemborexant)
- Doral (quazepam)
- Edluar (zolpidem)
- Estazolam
- Flurazepam
- Halcion (triazolam)
- Hetlioz (tasimelteon)
- Intermezzo (zolpidem)
- Lunesta (eszopiclone)
- Quviviq (daridorexant)
- Restoril (temazepam)
- Rozerem (ramelteon)
- Seconal (secobarbital)
- Silenor (doxepin)
- Sonata (zaleplon)
- Zolpimist (zolpidem)
Over-the-counter (OTC) Insomnia Drugs
*Also in many cold and headache combination products