Sodium oxybate has been well tolerated in relatively small clinical trials.
In the 4-week, placebo-controlled trial,3 nausea, headache, dizziness, and enuresis were most frequently reported. Out of 136 participants, 1 withdrew because of acute confusion and 9 others left because of mild to moderate adverse events. Twelve others experienced one episode of enuresis—probably because they did not fully awaken from deep sleep when developing urinary urgency. Advise patients taking sodium oxybate to urinate before going to bed.
The medication’s propensity to increase slow-wave sleep may cause sleepwalking. Sleepwalking was reported in 32% of patients in one long-term, uncontrolled study.5 If a patient with a history of sleepwalking needs sodium oxybate, advise against sleeping in upper bunks and other dangerous settings, and recommend precautions such as locking doors.
Because of sodium oxybate’s sedating properties, concomitant use of alcohol, barbiturates, and benzodiazepines should be discouraged.
As discussed, GHB has a high abuse potential with effects such as euphoria, relaxation, and heightened sexual feelings.
Tolerance and dependence has not been reported with sodium oxybate when used as prescribed. A withdrawal state—similar to alcohol and sedative/hypnotic withdrawal and marked by anxiety, tremor, agitation, and delirium—has been reported with GHB abuse (although other chemicals often are used simultaneously in such cases). Narcolepsy patients in clinical trials have abruptly discontinued sodium oxybate after months of use without significant withdrawal.4
- Narcolepsy Network Inc. www.narcolepsynetwork.org
Dr. Krahn reports no financial relationship with Orphan Medical or with manufacturers of competing products.