Extended-release zolpidem: Efficacy and tolerability profile

Drugs of Today

Volumn 42, Issue 11, 2006, Pages 721-727

  Owen, Richard T ^a  

^a Medical Information Department   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

FLURAZEPAM; PLACEBO; ZOLPIDEM;

AREA UNDER THE CURVE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; DIZZINESS; DOSE RESPONSE; DRUG ACTIVITY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; HEADACHE; HUMAN; INSOMNIA; NAUSEA; OPTIMAL DRUG DOSE; RANDOMIZED CONTROLLED TRIAL; REBOUND; REVIEW; RHINOPHARYNGITIS; SOMNOLENCE; TREATMENT RESPONSE;

DELAYED-ACTION PREPARATIONS; HUMANS; HYPNOTICS AND SEDATIVES; PYRIDINES; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME;

EID: 33846175685     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2006.42.11.1032060     Document Type: Review

References (15)

1. Rosenberg, R.P. Sleep maintenance insomnia: Strengths and weaknesses of current pharmacological therapies. Ann Clin Psychiatry 2006, 18: 49-56.
2. Scharf, M.B., Roth, T., Vogel, G.W., Walsh, J.K. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry 1994, 55: 192-9.
3. Lahmeyer, H., Wilcok, C.S., Kann, J., Leppik, I. Subjective efficacy of zolpidem in outpatients with chronic insomnia: A double-blind comparison with placebo. Clin Drug Invest 1997, 13: 134-44.
4. Zolpidem (Ambien®, Sanofi Aventis) prescribing information. Available at http://www.ambien.com.
5. Weinling, E., McDougall, S., Andre, S., Bianchetti, G., Dubruc, C. Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. Fundam Clin Pharmacol 2006, 20: 397-403.
6. Stanley, N., Hindmarch, I., Legangneux, E. et al. Zolpidem modified-release 12.5 mg improves measures of sleep continuity in a model of sleep disturbance (traffic noise) compared with standard zolpidem 10 mg. Pharmacotherapy 2005, 25: 1504, Abst. 321.
7. Hindmarch, I., Legagneux, E., Emegbo, S. Zolpidem modified release significantly reduces latency to persistent sleep 4 and 5 hours postdose compared with standard zolpidem in a model assessing the return to sleep following nocturnal awakening. Sleep 2005, 28 (Abst. Suppl.) A245-A246. Abst 0731, and poster presented at 158th American Psychiatric Association Meeting, Miami 2005, Poster NR585.
8. Greenblatt, D.J., Zammit, G., Harmatz, J., Legagneux, E. Zolpidem modified release demonstrates greater pharmacodynamic effects from 3 to 6 hours postdose as compared with standard zolpidem in healthy adult subjects. Sleep 2005, 28: A245, Abst. 0730.
9. Roth, T., Soubrane, C., Titeux, L., Walsh, J.K. Efficacy and safety of 12.5 mg of zolpidem ER: A double-blind, placebo-controlled study in adults with primary insomnia. Sleep Med 2006, 7: 397-406.
10. Roehrs, T., Soubrane, C., Roth, T. Zolpidem modified-release objectively and subjectively improves sleep maintenance and retains the characteristics of standard zolpidem on sleep induction and duration in elderly patients with primary insomnia. Sleep 2005, 28 (Abst. Suppl.). A244, Abst. 0725, and Poster presented at 158th American Psychiatric Association, Miami 2005, Poster NR586.
11. Erman, M., Krystal, A., Zammit, G., Soubrane, C., Roth, T. Zolpidem extended-release 12.5 mg taken for 24 weeks "as needed" up to 7 nights/week improves subjective measures of therapeutic global impression, sleep onset and sleep maintenance in patients with chronic primary insomnia. Int J Neuropsychopharmacology 2006, 9 (Suppl. 1): S256, Abst. P03.106.
12. Hindmarch, I., Legagneux, E., Stanley, N., Emegbo, S., Dawson, J. A double-blind, placebo-controlled investigation of the residual psychomotor and cognitive effects of zolpidem-MR in healthy elderly volunteers. Br J Clin Pharmacol 2006, 62: 538-45.
13. Blin, O., Micallef, J., Audebert, C., Legagneux, E. A double-blind, placebo and flurazepam-controlled investigation of the residual psychomotor and cognitive effects of modified release zolpidem in young healthy volunteers. J Clin Psychopharmacol 2006, 26: 284-9.
14. Ambien CR® (Sanofi Aventis) prescribing information. Available at http://www.ambiencr.com.
15. Investigational Drugs Database Report on zolpidem available at http://www.iddb3.com/iddb3/iddb3_2/reports.display?id=4723&template= Drug&i_query_id=7238699. Accessed November 28, 2006.