TRIP

Modafinil (Provigil) - Excessive sleepiness associated with obstructive sleep apnoea / hypopnoea syndrome

Scottish Medicines Consortium, 2006

Resubmission for new indication: excessive sleepiness associated with obstructive sleep apnoea / hypopnoea syndrome 10 February 2006 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland.
The advice is summarised as follows: ADVICE: following a resubmission modafinil (Provigil_) is not recommended for use within NHS Scotland for the treatment of excessive sleepiness associated with obstructive sleep apnoea / hypopnoea syndrome.
Modafinil demonstrated modest improvement in sleepiness and quality of life, the clinical significance of which is difficult to estimate.
Indication Treatment of excessive sleepiness associated with obstructive sleep apnoea / hypopnoea syndrome Dosing information 200mg to 400mg daily UK launch date December 2002
Comparator medications No other medicines are licensed in the UK for treatment of excessive sleepiness associated with obstructive sleep apnoea / hypopnoea syndrome (OSA/HS).
The Scottish Intercollegiate Guidelines Network (SIGN) advises that nasal continuous positive airways pressure (CPAP) is the treatment of choice for OSA/HS.
Cost of relevant comparators The annual costs of modafinil 200mg and 400mg daily are _1460 and _2920, respectively, using costs from eVadis drug dictionary accessed on 15th November 2005.
Summary of evidence on comparative efficacy Modafinil is a centrally acting sympathomimetic that promotes wakefulness by mechanisms which are not fully understood.
A double-blind 12-week trial randomised adults aged <70 years with OSA/HS and excessive daytime sleepiness, Epworth Sleepiness Scale (ESS) score 10 despite effective CPAP use, to placebo, modafinil 200mg or 400mg daily.
Efficacy was evaluated in 291 patients who were at least partially compliant with CPAP, received at least one dose of study drug and had at least one post-baseline assessment of an efficacy variable.
One of the primary endpoints was change from baseline to week 12 or final visit in mean sleep latency on the maintenance of wakefulness test (MWT), which averages time to sleep, measured by polysomnography, during four 20-minute nap opportunities each separated by two hours when the patient is asked to try to remain awake.