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
Article
in English
| LILACS
| ID: biblio-1089249
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
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Sleep Aids, Pharmaceutical
/
Sleep Initiation and Maintenance Disorders
Type of study:
Controlled clinical trial
/
Observational study
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
English
Journal:
Braz. J. Psychiatry (São Paulo, 1999, Impr.)
Journal subject:
Psychiatry
Year:
2020
Type:
Article
Affiliation country:
Brazil
Institution/Affiliation country:
Universidade Federal de São Paulo (UNIFESP)/BR
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