Safety and Efficacy of Chronic Hypnotic Use

NCT01006525 | Completed DMC

• 1 other identifier: R01DA017355
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (1)

• Sleep recording measures

  one year

Secondary Outcomes (1)

• Urine and saliva cortical levels

  one year

Study Arms (1)

Insomniacs

Primary insomniacs, ages 21-70, in good general health.

Drug: zolpidem

Interventions

zolpidem DRUG

placebo or zolpidem (10mg)daily for one year

Also known as: zolpidem (Ambien)

Insomniacs

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary insomniacs meeting DSM-IV criteria, ages 23-70 yrs. old, were recruited from public advisement for a double-blind placebo controlled study. Participants were in good general health as determined by a physical exam and laboratory tests. The Structured Clinical Interview for DSM Disorders (SCID) and the Hamilton Depression Scale were used to exclude those with psychiatric disorders, drug, and alcohol dependence. To confirm the absence of illicit drugs, participants underwent a urine drug screen. Additionally, participants had a screening sleep efficiency of \<85% on an 8-hr nocturnal polysomnogram (NPSG) and had no primary sleep disorders. Pregnant or lactating females were excluded from study participation.

You may qualify if:

• age 21-70 yrs
• non-pregnant females who agree to standard birth control for 12 months and males
• two of the following chronic insomnia complaints: \>30 min sleep latency, \< 6 hrs sleep, or nonrestorative sleep.
• meet DSM-IV criteria for primary insomnia

You may not qualify if:

• any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem.
• chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses.
• current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia.
• a history of alcohol or substance abuse within the past two years.
• a prestudy positive urine drug screen
• consuming \>14 standard (1oz) alcoholic drinks per week
• caffeine consumption \>300 mg/day
• smoking during the night (11pm-7am).
• medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented.
• sleep disordered breathing (SDB) defined as \>10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Sleep and Research Center

Detroit, Michigan, 48202, United States

Location

Related Publications (6)

• Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to rebound insomnia or withdrawal symptoms: a prospective placebo-controlled study. J Psychopharmacol. 2012 Aug;26(8):1088-95. doi: 10.1177/0269881111424455. Epub 2011 Oct 16.

  PMID: 22004689 RESULT

• Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to dose escalation: a prospective placebo-controlled study. Sleep. 2011 Feb 1;34(2):207-12. doi: 10.1093/sleep/34.2.207.

  PMID: 21286241 RESULT

• Roehrs T, Roth T. Hyperarousal in insomnia: pre-sleep and diurnal cortisol levels in response to chronic zolpidem treatment. Sleep Med. 2019 Sep;61:52-56. doi: 10.1016/j.sleep.2019.04.010. Epub 2019 Apr 25.

  PMID: 31255482 DERIVED

• Roehrs TA, Roth T. Hyperarousal in insomnia and hypnotic dose escalation. Sleep Med. 2016 Jul;23:16-20. doi: 10.1016/j.sleep.2016.06.008. Epub 2016 Jul 6.

  PMID: 27692272 DERIVED

• Roehrs TA, Roth T. Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem. J Clin Sleep Med. 2016 Mar;12(3):319-25. doi: 10.5664/jcsm.5574.

  PMID: 26446253 DERIVED

• Randall S, Roehrs TA, Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. Sleep. 2012 Nov 1;35(11):1551-7. doi: 10.5665/sleep.2208.

  PMID: 23115404 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and saliva

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Timothy A. Roehrs, Ph.D.

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Surilla Randall, Ph.D.

  Henry Ford Health System

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: December 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 7, 2011

Record last verified: 2011-11

Locations

US (1)