Modafinil as adjunct therapy
for daytime sleepiness in obstructive sleep apnea: a 12-week, open-label study.
Schwartz JR, Hirshkowitz M,
Erman MK, Schmidt-Nowara W.
Integris Sleep Disorders Center of Oklahoma
4200 S. Douglas, Suite 313, Oklahoma City, OK 73109 SchwJR@integris-health.com
Chest. 2003 Dec; 124(6): 2192-9.
Abstract
STUDY OBJECTIVES: The purpose of this 12-week
study was to evaluate the efficacy and safety of adjunct modafinil to treat
excessive sleepiness in patients with obstructive sleep apnea (OSA) who
experience residual sleepiness despite regular nasal continuous positive airway
pressure (nCPAP) use.
DESIGN: Twelve-week, open-label trial.
SETTING: Twenty-two centers in the United States.
PATIENTS: We studied 125 patients with moderate-to-severe OSA (ie, respiratory
disturbance index > or =15) before nCPAP therapy and residual daytime sleepiness
(Epworth sleepiness scale [ESS] score > or =10) despite effective and regular
nCPAP therapy. Patients were studied after completing a 4-week, double-blind,
placebo-controlled trial of nCPAP plus modafinil for the treatment of residual
daytime sleepiness. Interventions and measurements: Patients received
individually titrated doses of modafinil (200 to 400 mg qd). Sleepiness was
assessed using the ESS, quality of life was evaluated using the Functional
Outcomes of Sleep Questionnaire (FOSQ), and the overall clinical effect was
indexed using the clinical global impression of change scale. Adverse events,
nCPAP use, and vital sign measurements were also recorded.
RESULTS: The significant improvements in daytime wakefulness and sleep-related
functional status observed with modafinil treatment during the 4-week,
double-blind study were maintained throughout 12 weeks of open-label treatment:
week 12 ESS, 7.8 (4.7) vs 14.4 (3.1) at double-blind baseline; week 12 FOSQ, 3.3
(0.6) vs 14.4 (2.7) at double-blind baseline (mean [SD]). The percentage of
patients rated as clinically improved increased from 83% after 1 week to > or
=93% after 2 to 12 weeks of open-label treatment. Mean (SD) nCPAP use decreased
from 6.3 (1.3) h/night at baseline to 5.9 (1.4) h/night (p = 0.004) during
open-label treatment. The most common adverse events were headache (28%),
anxiety (16%), and nervousness (14%).
CONCLUSIONS: Modafinil remained effective and well tolerated as an adjunct
therapy for residual daytime sleepiness even after 12 weeks of daily dosing in
patients with OSA receiving nCPAP therapy.
1. Modafinil for
sustaining the alertness of helicopter pilots
2. Modafinil augmentation
of antidepressant treatment
3. Modafinil the
unique properties of a new stimulant
4. Modafinil children
with attention-deficit/hyperactivity disorder
5. Modafinil dosage
and safety
6. Modafinil successful
treatment of hypersomnia & narcolepsy
7. Modafinil narcolepsy:
symptoms and management
8. Modafinil
amplification of cortical serotonin release
9. Modafinil
treatment of alcoholic organic brain syndrome
10. Modafinil
effect on melatonin, cortisol, and growth hormone
11. Modafinil
in obstructive sleep apnea-hypopnea syndrome
12. Modafinil
vs dextroamphetamine in treatment of adult ADHD
13. Modafinil
efficacy in narcolepsy
14. Modafinil
switching from narcolepsy drugs to modafinil
15. Modafinil
dopaminergic transmission mediates CNS stimulants
