Meletonin/Autism

I have an 8 year old son who was diagnosed at three with Autism.  He has always had problems sleeping since he was an infant.  Although he should be tired, he would stay up till 12 or 1 am, and he would not be able to fall asleep.  He would yawn, but would lie awake with his bervous system and brain not cooperating to let him sleep.  He is not particularly hyper during the day.  I have tried altering his diet, no sugar caffiene msg etc.  I have tried routine and discipline, and have been firm and consistant with everything I tried.  Several years ago I decided to try him on meletonin.  He is now taking 1\2 of a 2.5 mg sublingual half an hour before bedtime.  This has worked for years very effectively, and also seems to improve his behavior the next day at school.  In all my reading there is no information about it's use in children.  The only thing I could find at all was a comment against it's use in children, but it did not list any reason or concern for that. During our history of using it I have tried on three occasions to stop using it.  Within days he was back to the same problem, and poor behaviors increased at school.  Please comment on what you know about it's usage with children.  Thank you.  JoAnn

[Kevin Kennedy, Ph.D.]

Dear JoAnn,

Many medications, both over-the-counter and prescription, are not exposed to clinical studies with children. Nonetheless, medications are used in clinical practice with children and, on the basis of clinical experience, some medications gain widespread use and are quite effective.

Unless clinical trials have been conducted with children, the FDA will always caution against use of a medication because, in a strict research sense, the safety and effectiveness have not been determined. Prescribing physicians employ their judgement, in addition to what they know via clinical trials, in their prescribing practices. And, in many instances, the applied clinical field is 'ahead' of the research field in the use of medications.

The use of melatonin is further complicated by the reality that it is not regulated in the sense that prescription medications are. As you know, it is available over the counter, and has been useful to both adults and children as an aide to sleep. However, you should be careful to discuss its use with your doctor(s) and see if they offer any reason why you should refrain from its use. Be sure to be forthcoming about your use of the medication and how successful you have found it.

[Jeff Luper]

CAUTIONS
          ADVERSE REACTIONS
               ADVERSE REACTIONS, CARDIOVASCULAR
                    A. CARDIOVASCULAR EFFECTS
                         1. TACHYCARDIA has been reported rarely after
                         melatonin administration (Claustrat et al, 1992); a
                         cause-effect relationship is doubtful.
               3.3.3 CENTRAL NERVOUS SYSTEM
                    A. CENTRAL NERVOUS SYSTEM EFFECTS
                         1. Four of 6 neurologically impaired children (ages
                         9 months to 18 years) who were given oral
                         melatonin 5 milligrams/night at bedtime for chronic
                         sleep complaints developed new or increased
                         seizure activity. In all cases, seizure activity returned
                         to pre-treatment levels after discontinuing melatonin.
                         Melatonin alleviated sleep disorders in 5 of the 6
                         children (Sheldon et al, 1998).
                         2. A 73-year-old woman with no history of
                         psychotic behavior was hospitalized for an ACUTE
                         PSYCHOTIC EPISODE after taking ten
                         3-milligram tablets of melatonin one morning after a
                         sleepless night. Her other regular medications were
                         thought not to be responsible for the episode. She
                         slept through the night of admission and had normal
                         mental status the next morning (Force et al, 1997).
                         3. ALTERED SLEEP PATTERNS have been
                         reported after the administration of melatonin
                         (Middleton et al, 1996).
                         4. Discontinuation of melatonin after 1 year of
                         nightly treatment (5 milligrams/night) resulted in
                         WITHDRAWAL-EMERGENT DYSKINESIA
                         and AKATHISIA in a 22-year-old woman who
                         suffered from spastic diplegia (from cerebral palsy)
                         and severe mental retardation. Melatonin treatment
                         was terminated because of repeated vomiting. One
                         week later, the woman began to develop
                         involuntary lip- smacking movements and tongue
                         protrusion, with moaning, shouting, and
                         restlessness. Reintroduction of melatonin in
                         gradually increasing doses caused disappearance of
                         the involuntary motions and improvement of
                         agitation and insomnia. A month later, another
                         episode of abdominal pain resulted in termination of
                         melatonin, with the same consequences. When
                         melatonin 5 milligrams per night was reinstituted, all
                         symptoms disappeared the next day. Melatonin was
                         then stopped gradually over a 2-month period
                         without any movement abnormalities. The authors
                         cautioned against the use of melatonin in patients
                         with organic brain damage (Giladi

[Jeff Luper]

CAUTIONS
          ADVERSE REACTIONS
               ADVERSE REACTIONS, CARDIOVASCULAR
                    A. CARDIOVASCULAR EFFECTS
                         1. TACHYCARDIA has been reported rarely after
                         melatonin administration (Claustrat et al, 1992); a
                         cause-effect relationship is doubtful.
               3.3.3 CENTRAL NERVOUS SYSTEM
                    A. CENTRAL NERVOUS SYSTEM EFFECTS
                         1. Four of 6 neurologically impaired children (ages
                         9 months to 18 years) who were given oral
                         melatonin 5 milligrams/night at bedtime for chronic
                         sleep complaints developed new or increased
                         seizure activity. In all cases, seizure activity returned
                         to pre-treatment levels after discontinuing melatonin.
                         Melatonin alleviated sleep disorders in 5 of the 6
                         children (Sheldon et al, 1998).
                         2. A 73-year-old woman with no history of
                         psychotic behavior was hospitalized for an ACUTE
                         PSYCHOTIC EPISODE after taking ten
                         3-milligram tablets of melatonin one morning after a
                         sleepless night. Her other regular medications were
                         thought not to be responsible for the episode. She
                         slept through the night of admission and had normal
                         mental status the next morning (Force et al, 1997).
                         3. ALTERED SLEEP PATTERNS have been
                         reported after the administration of melatonin
                         (Middleton et al, 1996).
                         4. Discontinuation of melatonin after 1 year of
                         nightly treatment (5 milligrams/night) resulted in
                         WITHDRAWAL-EMERGENT DYSKINESIA
                         and AKATHISIA in a 22-year-old woman who
                         suffered from spastic diplegia (from cerebral palsy)
                         and severe mental retardation. Melatonin treatment
                         was terminated because of repeated vomiting. One
                         week later, the woman began to develop
                         involuntary lip- smacking movements and tongue
                         protrusion, with moaning, shouting, and
                         restlessness. Reintroduction of melatonin in
                         gradually increasing doses caused disappearance of
                         the involuntary motions and improvement of
                         agitation and insomnia. A month later, another
                         episode of abdominal pain resulted in termination of
                         melatonin, with the same consequences. When
                         melatonin 5 milligrams per night was reinstituted, all
                         symptoms disappeared the next day. Melatonin was
                         then stopped gradually over a 2-month period
                         without any movement abnormalities. The authors
                         cautioned against the use of melatonin in patients
                         with organic brain damage (Giladi