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Carson S, McDonagh MS, Thakurta S, et al. Drug Class Review: Newer Drugs for Insomnia: Final Report Update 2 [Internet]. Portland (OR): Oregon Health & Science University; 2008 Oct.

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Drug Class Review: Newer Drugs for Insomnia: Final Report Update 2 [Internet].

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Appendix D. Summary of results of trials comparing newer insomnia drugs compared with benzodiazepines

(No new trials were identified for Update #2)

ComparisonKQ outcomeaHypnoticFindingBenzodiazepine(No. of Studies) Citationsb
Zaleplon compared with triazolam
Effectiveness outcomesZaleplon 5, 10 mg=,=Triazolam 0.25 mg(2)1, 2
Effectiveness outcomesZaleplon 20 mgTriazolam 0.25 mg(1)2
Effectiveness outcomesZaleplon 40–60 mgMixedTriazolam 0.25 mg(1)2
Safety outcomesZaleplon 5, 10 mg=Triazolam 0.25 mg(1)1
NauseaZaleplon 5 mg>Triazolam 0.25 mg(1)1
Zolpidem compared with flurazepam
Effectiveness outcomesZolpidem 10, 20 mg>Flurazepam 30 mg(1)3
Safety outcomesZolpidem 10 mg=Flurazepam 30 mg(1)3
Safety outcomesZolpidem 20 mg<Flurazepam 30 mg(1)3
Zolpidem compared with temazepam
Effectiveness outcomesZolpidem 5 mg=Temazepam 15 mg(1)4
Effectiveness outcomesZolpidem 10 mg=Temazepam 20 mg(1)5
Less reboundZolpidem 10 mg=Temazepam 20 mg(1)5
Zolpidem compared with trazodone
Effectiveness outcomesZolpidem 10 mg=Trazodone 50 mg(1)6
Zolpidem compared with triazolam
Effectiveness outcomesZolpidem 5 mg>Triazolam 0.125 mg(1)4
Effectiveness outcomesZolpidem 10 mg=,=Triazolam 0.25 mg(2)7, 8
Effectiveness outcomesZolpidem 10 mg>Triazolam 0.5 mg(1)9
Less reboundZolpidem 5 mg>Triazolam 0.25 mg(1)7
Less reboundZolpidem 10 mg,>Triazolam 0.25 mg(2)7, 8
Less reboundZolpidem 10 mg>Triazolam 0.5 mg(1)9
Zopiclone compared with flurazepam
Effectiveness outcomesZopiclone 3.75 mg=Flurazepam 30 mg(1)10
Effectiveness outcomesZopiclone 7.5 mg=,,=Flurazepam 30 mg(3)10–12
Effectiveness outcomesZopiclone 11.5 mg=,Flurazepam 30 mg(2)10, 11
Effectiveness outcomesZopiclone 15 mg=Flurazepam 30 mg(1)10
Safety outcomesZopiclone 7.5 mg=,=Flurazepam 30 mg(1)13, 14
Less reboundZopiclone 7.5 mgFlurazepam 30 mg(1)12
Zopiclone compared with nitrazepam
Effectiveness outcomesZopiclone 7.5 mg=,=Nitrazepam 5 mg(2)15, 16
Daytime alertnessZopiclone 7.5 mg>,Nitrazepam 5 mg(2)15, 16
Safety outcomesZopiclone 7.5 mg=Nitrazepam 5 mg(1)15
Zopiclone compared with temazepam
Effectiveness outcomesZopiclone 7.5 mg=,=,=Temazepam 20, 30 mg(3)17–19
Safety outcomesZopiclone 7.5 mg=Temazepam 20 mg(1)17
Zopiclone compared with triazolam
Effectiveness outcomesZopiclone 7.5 mg=,=,=Triazolam 0.25 mg(3)20–22
Safety outcomesZopiclone 7.5 mg=Triazolam 0.25 mg(1)20
Less reboundZopiclone 7.5 mg>,Triazolam 0.25 mg(2)21, 23

≥, some outcomes showed a preference for the newer sedative hypnotic and others were equivalent;

≤, some outcomes showed a preference for the benzodiazepine and others were equivalent;

>, all outcomes (or the majority of outcomes) showed a preference for the newer sedative hypnotic;

<, all outcomes (or the majority of outcomes) showed a preference for the benzodiazepine;

=, all outcomes (or the majority of outcomes) showed no difference between the benzodiazepine and the newer sedative hypnotic;

Mixed, some outcomes showed a preference for the newer sedative hypnotic and others showed a preference for the benzodiazepine.

a

Efficacy outcomes of individual studies were Sleep Duration, length of sleep, total sleep time; Sleep Quality, sleep efficiency, number of awakenings, Night awakenings, wake time after sleep onset, Daytime alertness, status of work, drowsiness, quality of morning awakening, morning state, feelings on awakenings, daytime well-being, Mental alertness on rising, morning sleepiness, morning alertness, Sleep latency, rapidity of sleep onset, sleep induction, sleep onset duration, Delay in falling sleep, latency to persistent sleep, Safety outcomes in individual studies were overall adverse events, side effects, and safety. Rebound insomnia: Rebound, withdrawal effects

b

See Evidence Tables 4 through 9 for details of the population, interventions, and outcomes of these studies.

References

1.
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. Clinical Drug Investigation. 1998b;16(5):347–354.
2.
Drake CL, Roehrs TA, Mangano RM, Roth T. Dose-response effects of zaleplon as compared with triazolam (0.25 mg) and placebo in chronic primary insomnia. Human Psychopharmacology. 2000;15(8):595–604. [PubMed: 12404612]
3.
Fleming J, Moldofsky H, Walsh JK, Scharf M, Nino MG, Radonjic D. Comparison of the residual effects and efficacy of short term zolpidem, flurazepam and placebo in patients with chronic insomnia. Clinical Drug Investigation. 1995;9(6):303–313.
4.
Leppik IE, Roth-Schechter GB, Gray GW, Cohn MA, Owens D. Double-blind, placebo-controlled comparison of zolpidem, triazolam, and temazepam in elderly patients with insomnia. Drug Development Research. 1997;40(3):230–238.
5.
Voshaar RC, van Balkom AJ, Zitman FG. Zolpidem is not superior to temazepam with respect to rebound insomnia: a controlled study. European Neuropsychopharmacology. 2004;14(4):301–306. [PubMed: 15163440]
6.
Walsh JK, Erman M, Erwin CW, et al. Subjective hypnotic efficacy of trazodone and zolpidem in DSMIII-R primary insomnia. Human Psychopharmacology. 1998a;13:191–198.
7.
Roger M, Attali P, Coquelin JP. Multicenter, double-blind, controlled comparison of zolpidem and triazolam in elderly patients with insomnia. Clinical Therapeutics. 1993;15(1):127–136. [PubMed: 8458042]
8.
Silvestri R, Ferrillo F, Murri L, et al. Rebound insomnia after abrupt discontinuation of hypnotic treatment: Double-blind randomized comparison of zolpidem versus triazolam. Human Psychopharmacology. 1996;11(3):225–233.
9.
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10.
Nair NP, Schwartz G, Dimitri R, Le Morvan P, Thavundayil JX. A dose-range finding study of zopiclone in insomniac patients. International Clinical Psychopharmacology. 1990;5(2):1–10. [PubMed: 2201721]
11.
Singh AN, Bourgouin J. Comparison of zopiclone and flurazepam treatments in insomnia. Human Psychopharmacology. 1990;5(3):217–223.
12.
Mamelak M, Buck L, Csima A, Price V, Smiley A. Effects of flurazepam and zopiclone on the performance of chronic insomniac patients: a study of ethanol-drug interaction. Sleep. 1987;10(1):79–87. [PubMed: 3438646]
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14.
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15.
Anderson AA. Zopiclone and nitrazepam: a multicenter placebo controlled comparative study of efficacy and tolerance in insomniac patients in general practice. Sleep. 1987;10(1):54–62. [PubMed: 3326116]
16.
Klimm HD, Dreyfus JF, Delmotte M. Zopiclone versus nitrazepam: a double-blind comparative study of efficacy and tolerance in elderly patients with chronic insomnia. Sleep. 1987;10(1):73–78. [PubMed: 3326118]
17.
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18.
van der Kleijn E. Effects of zopiclone and temazepam on sleep, behaviour and mood during the day. European Journal of Clinical Pharmacology. 1989;36(3):247–251. [PubMed: 2744064]
19.
Stip E, Furlan M, Lussier I, Bourgouin P, Elie R. Double-blind, placebo-controlled study comparing effects of zopiclone and temazepam on cognitive functioning of insomniacs. Human Psychopharmacology. 1999;14(4):253–261.
20.
Chaudoir PJ, Bodkin NL, O'Donnell J, Anderson A, Holland RL. A comparative study of zopiclone and triazolam in patients with insomnia. International Clinical Psychopharmacology. 1990;5(2):21–27. [PubMed: 2201727]
21.
Hajak G, Clarenbach P, Fischer W, et al. Rebound insomnia after hypnotic withdrawal in insomniac outpatients. European Archives of Psychiatry & Clinical Neuroscience. 1998;248(3):148–156. [PubMed: 9728734]
22.
Hayoun G, Bagot C. Comparative efficacy and safety of triazolam and zopiclone in insomniacs seen in general practice. Current Therapeutic Research - Clinical and Experimental. 1989;46(6):1236–1244.
23.
Fleming JA, McClure DJ, Mayes C, Phillips R, Bourgouin J. A comparison of the efficacy, safety and withdrawal effects of zopiclone and triazolam in the treatment of insomnia. International Clinical Psychopharmacology. 1990;5(2):29–37. [PubMed: 2201728]
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.
Bookshelf ID: NBK47213

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