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                Postmarket Drug Safety Information for Patients and Providers

Postmarket Drug Safety Information for Patients and Providers

                        Index to Drug-Specific Information Home
          Drugs
          Drug Safety and Availability
          Postmarket Drug Safety Information for Patients and Providers
          Sleep Disorder (Sedative-Hypnotic) Drug InformationPostmarket Drug Safety Information for Patients and Providers Sleep Disorder (Sedative-Hypnotic) Drug Information
  
  	
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    Print**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**

Benadryl (diphenhydramine)*
	Unisom (doxylamine)**Also in many cold and headache combination products

Related Information

Questions and Answers: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)
	Taking Z-drugs for Insomnia? Know the Risks

                                                                                  Content current as of:
      06/29/2023
              
              
Regulated Product(s)
		 DrugsPostmarket Drug Safety Information for Patients and Providers

          
                        Index to Drug-Specific Information
 
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