Novel sublingual low-dose zolpidem tablet reduces latency to sleep onset following spontaneous middle-of-the-night awakening in insomnia in a randomized, double-blind, placebo-controlled, outpatient study

Sleep

Volumn 36, Issue 2, 2013, Pages 189-196

  Roth, Thomas ^a   Krystal, Andrew ^b   Steinberg, Frank J ^c   Singh, Nikhilesh N ^c   Moline, Margaret ^d  

^a HENRY FORD HOSPITAL   (United States)

^b DUKE UNIVERSITY   (United States)

^c Transcept Pharmaceuticals Inc   (United States)

^d PURDUE PHARMA L P   (United States)

Author keywords

Insomnia; Middle of the night awakenings; MOTN insomnia; Pharmacotherapy; Zolpidem

Indexed keywords

INTERMEZZO; PLACEBO; UNCLASSIFIED DRUG; ZOLPIDEM;

ADULT; ALERTNESS; AROUSAL; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; FATIGUE; FEMALE; HUMAN; INSOMNIA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; NAUSEA; NIGHT; OUTPATIENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPONSE TIME; SLEEP QUALITY; SOMNOLENCE; TABLET FORMULATION;

ADMINISTRATION, SUBLINGUAL; ADULT; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPNOTICS AND SEDATIVES; MALE; PYRIDINES; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME;

EID: 84873363660     PISSN: 01618105     EISSN: 15509109     Source Type: Journal    
DOI: 10.5665/sleep.2370     Document Type: Article

References (12)

1. Ohayon MM, Roth T. What are the contributing factors for insomnia in the general population? J Psychosom Res 2001;51:745-55.
2. Ohayon MM, Krystal A, Roehrs TA, Roth T, Vitiello MV. Using difficulty resuming sleep to define nocturnal awakenings. Sleep Med 2010;11:236-41.
3. Estivill E. Behaviour of insomniacs and implication for their management. Sleep Med Rev 2002;6:S3-6.
4. Roth T, Mayleben D, Corser BC, Singh N. Daytime pharmacodynamic and pharmacokinetic evaluation of low-dose transmucosal zolpidem. Hum Psychopharmacol 2008;23:13-20.
5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index. cfm?fuseaction=Search.DrugDetails. Accessed August 18, 2012.
6. Roth T, Krystal AD, Maguire Y, Singh N, Maytom M. Pharmacokinetics of the sublingual zolpidem tartrate 3.5 mg lozenge compared to the oral zolpidem tartrate 10 mg tablet. Sleep 2008;31:A235.
7. Roth T, Hull SG, Lankford DA, Rosenberg R, Scharf MB. Low-dose sublingual zolpidem tartrate is associated with dose-related improvement in sleep onset and duration in insomnia characterized by middle-of-the-night (MOTN) awakenings. Sleep 2008;31:1277-84.
8. Diagnostic and statistical manual of mental disorders, 4th edition, text revision. Washington, DC: American Psychiatric Association, 2000.
9. Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto U. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. Br Med J 2005;19:1169-76.
10. Krystal AD, Lankford A, Durrence HH, et al. Efficacy and safety of doxepin 3 and 6 mg in a 35-day sleep laboratory trial in adults with chronic primary insomnia. Sleep 2011;34:1433-42.
11. Walsh JK, Fry J, Erwin CW, Scharf M, Roth T, Vogel GW. Efficacy and tolerability of 14-day administration of zaleplon 5 mg and 10 mg for the treatment of primary insomnia. Clin Drug Invest 1998;16:347-54.
12. Roth T, Zammit GK, Scharf MB, Farber R. Efficacy and safety of asneeded, post bedtime dosing with indiplon in insomnia patients with chronic difficulty maintaining sleep. Sleep 2007;30:1731-8.