Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial
Autor(a) principal: | |
---|---|
Data de Publicação: | 2020 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Psychiatry (São Paulo. 1999. Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462020000200175 |
Resumo: | Objective: To evaluate the safety and efficacy of a 5 mg sublingual dose of zolpidem, compared to a 10 mg oral dose, at bedtime and “as needed” following middle-of-the-night awakenings. Methods: Participants were randomized into an oral group (oral zolpidem 10 mg and sublingual placebo at bedtime and “as-needed”) and a sublingual group (oral placebo and sublingual zolpidem 5 mg at bedtime and “as-needed”). Participants underwent medical evaluation, polysomnography, the psychomotor vigilance test, and completed questionnaires. Results: Of 85 patients, 67 met the criteria for insomnia (48±10 years; 79% women) and were randomized. Of these, 46 completed 92±5 days of treatment. Mild-to-moderate adverse events were reported by 25% of the participants, including headache, sleepiness, and dizziness. Both treatments decreased middle-of-the-night awakenings by an average of -3.1±2.3 days/week and increased total sleep time by 1.5 hours. Changes in sleep quality and insomnia severity scores were also favorable and comparable between groups: variation depended on continuation of treatment. Regarding PSG findings, sleep latency decreased more in the sublingual group than the oral group (-14±42 vs. 10±29 min; p = 0.03). The psychomotor vigilance test showed minor residual effects 30 minutes after awakening, which reversed after 2 hours. Conclusions: The safety and efficacy of both zolpidem formulations are comparable. The sublingual 5 mg dose induced sleep more rapidly. Clinical trial registration: NCT01896336 |
id |
ABP-1_aacbe9f7cf934494ef4a7e43e3ae7398 |
---|---|
oai_identifier_str |
oai:scielo:S1516-44462020000200175 |
network_acronym_str |
ABP-1 |
network_name_str |
Brazilian Journal of Psychiatry (São Paulo. 1999. Online) |
repository_id_str |
|
spelling |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trialChronic insomniapolysomnographypsychomotor performancesleep diariesclinical effectiveness Objective: To evaluate the safety and efficacy of a 5 mg sublingual dose of zolpidem, compared to a 10 mg oral dose, at bedtime and “as needed” following middle-of-the-night awakenings. Methods: Participants were randomized into an oral group (oral zolpidem 10 mg and sublingual placebo at bedtime and “as-needed”) and a sublingual group (oral placebo and sublingual zolpidem 5 mg at bedtime and “as-needed”). Participants underwent medical evaluation, polysomnography, the psychomotor vigilance test, and completed questionnaires. Results: Of 85 patients, 67 met the criteria for insomnia (48±10 years; 79% women) and were randomized. Of these, 46 completed 92±5 days of treatment. Mild-to-moderate adverse events were reported by 25% of the participants, including headache, sleepiness, and dizziness. Both treatments decreased middle-of-the-night awakenings by an average of -3.1±2.3 days/week and increased total sleep time by 1.5 hours. Changes in sleep quality and insomnia severity scores were also favorable and comparable between groups: variation depended on continuation of treatment. Regarding PSG findings, sleep latency decreased more in the sublingual group than the oral group (-14±42 vs. 10±29 min; p = 0.03). The psychomotor vigilance test showed minor residual effects 30 minutes after awakening, which reversed after 2 hours. Conclusions: The safety and efficacy of both zolpidem formulations are comparable. The sublingual 5 mg dose induced sleep more rapidly. Clinical trial registration: NCT01896336Associação Brasileira de Psiquiatria2020-04-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462020000200175Brazilian Journal of Psychiatry v.42 n.2 2020reponame:Brazilian Journal of Psychiatry (São Paulo. 1999. Online)instname:Associação Brasileira de Psiquiatria (ABP)instacron:ABP10.1590/1516-4446-2019-0389info:eu-repo/semantics/openAccessCastro,Laura S.Otuyama,Leonardo J.Fumo-dos-Santos,CristianeTufik,SergioPoyares,Dalvaeng2020-04-08T00:00:00Zoai:scielo:S1516-44462020000200175Revistahttp://www.bjp.org.br/ahead_of_print.asphttps://old.scielo.br/oai/scielo-oai.php||rbp@abpbrasil.org.br1809-452X1516-4446opendoar:2020-04-08T00:00Brazilian Journal of Psychiatry (São Paulo. 1999. Online) - Associação Brasileira de Psiquiatria (ABP)false |
dc.title.none.fl_str_mv |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial |
title |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial |
spellingShingle |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial Castro,Laura S. Chronic insomnia polysomnography psychomotor performance sleep diaries clinical effectiveness |
title_short |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial |
title_full |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial |
title_fullStr |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial |
title_full_unstemmed |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial |
title_sort |
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial |
author |
Castro,Laura S. |
author_facet |
Castro,Laura S. Otuyama,Leonardo J. Fumo-dos-Santos,Cristiane Tufik,Sergio Poyares,Dalva |
author_role |
author |
author2 |
Otuyama,Leonardo J. Fumo-dos-Santos,Cristiane Tufik,Sergio Poyares,Dalva |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Castro,Laura S. Otuyama,Leonardo J. Fumo-dos-Santos,Cristiane Tufik,Sergio Poyares,Dalva |
dc.subject.por.fl_str_mv |
Chronic insomnia polysomnography psychomotor performance sleep diaries clinical effectiveness |
topic |
Chronic insomnia polysomnography psychomotor performance sleep diaries clinical effectiveness |
description |
Objective: To evaluate the safety and efficacy of a 5 mg sublingual dose of zolpidem, compared to a 10 mg oral dose, at bedtime and “as needed” following middle-of-the-night awakenings. Methods: Participants were randomized into an oral group (oral zolpidem 10 mg and sublingual placebo at bedtime and “as-needed”) and a sublingual group (oral placebo and sublingual zolpidem 5 mg at bedtime and “as-needed”). Participants underwent medical evaluation, polysomnography, the psychomotor vigilance test, and completed questionnaires. Results: Of 85 patients, 67 met the criteria for insomnia (48±10 years; 79% women) and were randomized. Of these, 46 completed 92±5 days of treatment. Mild-to-moderate adverse events were reported by 25% of the participants, including headache, sleepiness, and dizziness. Both treatments decreased middle-of-the-night awakenings by an average of -3.1±2.3 days/week and increased total sleep time by 1.5 hours. Changes in sleep quality and insomnia severity scores were also favorable and comparable between groups: variation depended on continuation of treatment. Regarding PSG findings, sleep latency decreased more in the sublingual group than the oral group (-14±42 vs. 10±29 min; p = 0.03). The psychomotor vigilance test showed minor residual effects 30 minutes after awakening, which reversed after 2 hours. Conclusions: The safety and efficacy of both zolpidem formulations are comparable. The sublingual 5 mg dose induced sleep more rapidly. Clinical trial registration: NCT01896336 |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-04-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462020000200175 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462020000200175 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/1516-4446-2019-0389 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Associação Brasileira de Psiquiatria |
publisher.none.fl_str_mv |
Associação Brasileira de Psiquiatria |
dc.source.none.fl_str_mv |
Brazilian Journal of Psychiatry v.42 n.2 2020 reponame:Brazilian Journal of Psychiatry (São Paulo. 1999. Online) instname:Associação Brasileira de Psiquiatria (ABP) instacron:ABP |
instname_str |
Associação Brasileira de Psiquiatria (ABP) |
instacron_str |
ABP |
institution |
ABP |
reponame_str |
Brazilian Journal of Psychiatry (São Paulo. 1999. Online) |
collection |
Brazilian Journal of Psychiatry (São Paulo. 1999. Online) |
repository.name.fl_str_mv |
Brazilian Journal of Psychiatry (São Paulo. 1999. Online) - Associação Brasileira de Psiquiatria (ABP) |
repository.mail.fl_str_mv |
||rbp@abpbrasil.org.br |
_version_ |
1754212559224832000 |