Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial
Braz. J. Psychiatry (São Paulo, 1999, Impr.)
; 42(2): 175-184, Mar.-Apr. 2020. tab, graf
Artigo
em Inglês
| LILACS
| ID: biblio-1089249
Biblioteca responsável:
BR1.1
ABSTRACT
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
Texto completo:
Disponível
Coleções:
Bases de dados internacionais
Base de dados:
LILACS
Assunto principal:
Medicamentos Indutores do Sono
/
Distúrbios do Início e da Manutenção do Sono
Tipo de estudo:
Ensaio clínico controlado
/
Estudo observacional
Limite:
Adulto
/
Feminino
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
Braz. J. Psychiatry (São Paulo, 1999, Impr.)
Assunto da revista:
Psiquiatria
Ano de publicação:
2020
Tipo de documento:
Artigo
País de afiliação:
Brasil
Instituição/País de afiliação:
Universidade Federal de São Paulo (UNIFESP)/BR